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Effect of exercise alone and in combination with time-restricted eating on cardiometabolic health in menopausal women

Journal of Translational Medicine volume 22, Article number: 957 (2024) Cite this article

Abstract

There is a need to investigate the effect of lifestyle modifications on cardiometabolic health-related issues that occur during menopause. The aim of this study was to compare the effect of resistance and endurance circuit training program alone (exercise group, n = 34) with the effect of time-restricted eating (16:8) combined with a training program (combination group, n = 28) on cardiometabolic health in 62 menopausal women (aged 51.3 ± 4.69 years). Testing was conducted before and after a 12-week period and included an assessment of body composition, glycemic control, lipid panel, blood pressure, and anthropometric measurements. Decreases in body mass index and systolic blood pressure were significantly greater in the combination group than in the exercise group (F(1,60) = 4.482, p = 0.038, η2 = 0.07; F(1,57) = 5.215, p = 0.026, η2 = 0.08, respectively, indicating moderate effects). There were significant decreases in fat mass (p = 0.001, r = 0.654), glucose level (p = 0.017, r = 0.459), insulin level (p = 0.013, r = 0.467), homeostatic model assessment for insulin resistance (p = 0.009, r = 0.499), waist circumference (p = 0.002, r = 0.596), and waist-to-height ratio (p = 0.003, r = 0.588) (indicating moderate effect) in the combination group, while there were no significant changes in the exercise group. There were no changes in lipid panel indicators in either group. This is the first study to investigate the effect of time-restricted eating combined with exercise in menopausal women. The results of the study provide evidence that the combination of time-restricted eating and exercise leads to a greater body mass index reduction than exercise alone in menopausal women.

Trial registration: ClinicalTrials.gov, NCT06138015 registered 18 November 2023—Retrospectively registered, https://clinicaltrials.gov/study/NCT06138015.

Background

The female population is aging and facing many health issues related to menopause. Menopause is a state defined by the decrease in and the cessation of estrogen production by the ovaries, which typically occurs between the ages of 45 and 55 [1]. During menopause, several metabolic (e.g., decreased glucose tolerance/insulin resistance, increased low-density lipoprotein, decreased high-density lipoprotein) and somatic (e.g., hot flashes, heart palpitations, irritability) changes occur [2, 3]. Metabolic and somatic changes are likely associated with decreased estrogen levels and the regulation of neurotransmitter systems [4]. Decreased ovarian estrogen production is the most studied factor linking menopause and cardiometabolic health. However, the mechanisms underlying the menopausal transition and cardiometabolic health decline are not well understood [5]. Nevertheless, lifestyle modifications, such as exercise and diet, can reduce the severity of or delay the onset of menopausal symptoms [2, 6], and decrease cardiometabolic risk [7,8,9,10,11] in menopausal women. Physical training reduces the risk of cardiovascular diseases in menopausal women [9]. Higher physical activity levels are associated with lower cardiometabolic risk in menopausal women [8]. One example of a diet that has been studied in menopausal women is the Mediterranean diet which demonstrated positive effects on cardiometabolic risk factors [11].

Intermittent fasting (IF) is an eating pattern consisting of periods of fasting and periods of consumption [12]. Time-restricted eating (TRE) is a type of intermittent fasting that involves consuming meals within a limited time window, followed by a period of fasting. The duration of the eating window varies depending on the selected model, with a range of 6–12 h, with an average of 8 h [13]. Another example of a type of intermittent fasting is alternate-day fasting (ADF), which involves alternating between days of eating ad libitum with days of fasting [14]. Recently, IF has received considerable attention from researchers because of its positive effects on health and metabolism [15].

The molecular mechanism underlying the beneficial effects of IF on cardiometabolic health is characterized by a shift from fat to ketone metabolism and the modulation of cellular adaptive responses such as autophagy [16]. The circadian clock influences gene expression and has a wide-ranging impact on different organs as well as the network of neurohormonal signals that regulate weight control [17]. Disruption of circadian genes affects glucose and lipid homeostasis and increases insulin resistance [18]. IF restores the expression of genes that regulate circadian rhythm [19]. IF exerts cardiovascular protective effects and has been reported to restore the circadian rhythm of blood pressure levels through the inhibition of sympathetic activity [20]. Intermittent fasting has demonstrated positive effects on obesity, insulin resistance, type 2 diabetes, hypertension, and cardiovascular risk factors [12, 21]. However, the findings regarding low-density lipoprotein cholesterol and triglyceride levels are inconsistent [22]. IF is mostly examined in participants with obesity. There is little research regarding the effect of fasting strategies in menopausal women. Nevertheless, evidence indicates that physical exercise has a beneficial impact on body composition, glycemic control, and cardiovascular risk factors in menopausal women [8, 23].

The combination of intermittent fasting and physical exercise has been proven to promote fat loss and maintain lean body mass in individuals with overweight or obesity and in young adults [24, 25]. It is crucial to determine whether the positive effects of combining these strategies can be utilized as an effective approach for maintaining health during and after the menopausal transition. There have been no previous studies that have investigated the effect of combining IF and exercise in menopausal women. Prior studies have not yet examined the impact of combining TRE with exercise over a period exceeding 8 weeks [24, 26]. Treatment and prevention options for cardiometabolic health decline during menopausal transition range from hormone replacement therapy to lifestyle modifications such as diet and physical activity [27]. In comparison to hormone replacement therapy, diet and exercise are more cost-effective and have fewer contraindications or side effects. The findings of this study may contribute to the development of effective physical activity and nutritional strategies that could be integrated into guidelines for the general population of menopausal women.

The positive effects of physical activity or intermittent fasting on cardiometabolic health are well established. Additionally, some studies suggest that combining exercise with IF may lead to even greater health benefits. However, this combination has not been previously studied in menopausal women. Therefore, it remains unclear whether the combination of TRE and exercise provides additional cardiometabolic benefits compared to exercise alone in this population. The aim of the study was to evaluate whether the combination of exercise and TRE has a more significant impact on cardiometabolic health in menopausal women than exercise alone. The authors hypothesized that implementing TRE alongside exercise would result in greater improvements in body composition and cardiometabolic health markers than implementing exercise alone in menopausal women.

Methods

Primary and secondary outcomes

The primary outcome measures were the changes from baseline to week 12 in fat mass (FM), muscle mass (MM), body mass index (BMI), homeostatic model assessment for insulin resistance (HOMA-IR), low-density lipoprotein (LDL) cholesterol level, systolic blood pressure (SBP), and diastolic blood pressure (DBP).

The secondary outcome measures were the changes from baseline to week 12 in fat-free mass (FFM), total body water (TBW), the extracellular water to total body water ratio (ECW/TBW), glucose level, insulin level, total cholesterol level, high-density lipoprotein (HDL) cholesterol level, non-high-density lipoprotein (non-HDL) cholesterol level, triglyceride level, systemic immune-inflammation index (SII), waist circumference (WC), hip circumference (HC), waist-to-height ratio (WHtR).

Participants

Sample size calculations (G*Power 3.1.7) revealed that a minimum sample size of 62 participants would be appropriate to detect significant differences between the groups, assuming an effect size ηp2 = 0.12, a type I error of 0.05, and a power of 0.80. On the basis of a prediction of a dropout rate of 20%, an estimated 74 participants were required to achieve a total of 62 participants. Participants were recruited in Poznan, Poland. The key inclusion criteria were as follows: aged 41–61 years; perimenopausal (women with irregular bleeding during the last 12 months), menopausal (women with amenorrhea during the last year) or postmenopausal (women with no menstrual bleeding for 1 year or more); and lightly active or inactive (i.e., <3 h/week of light-intensity exercise at 2.5–4.0 metabolic equivalents (METs). The level of physical activity was measured via the Global Physical Activity Questionnaire [28]. The exclusion criteria were: using hormone replacement therapy, using hormonal contraception, cardiovascular disease, type 1 or 2 diabetes mellitus, taking antihypertensive medication, glucose- or lipid-lowering medication, variation in body mass ≥ 4 kg in the last 3 months, a history of eating disorders, or working night shifts. Participants with contraindications for physical exercise or fasting were excluded from the study by an experienced physician. Of the 243 individuals who expressed interest in the study, 80 met the criteria (Fig. 1). The experimental protocol was approved by the Bioethical Committee of the Poznan University of Medical Sciences KB-179/21 in accordance with the Declaration of Helsinki [29], and all volunteers provided their written informed consent to participate in the trial. The experiment was registered at ClinicalTrials.gov (identifier: NCT06138015).

Fig. 1
figure 1

Flow diagram of the study following CONSORT guidelines

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Study design and procedures

A 12-week quasi-experimental trial was implemented to test the effects of exercise (exercise group) and TRE combined with exercise (combination group) on cardiometabolic health in menopausal women. Eligible participants were distributed into two groups: 1) a combination group; 2) an exercise group. The combination group took part in both dietary and exercise intervention. The exercise group underwent exercise intervention only. The 12-week clinical trial was run in 3 bouts. The first bout took place from October 2021 to December 2021, and the second bout took place from January 2022 to March 2022, and the third bout took place from October 2022 to December 2022. Recruitment took place during a 4-week period before the beginning of each bout. Participants were recruited through advertisements on the university website. In the first bout, participants were assigned to groups in an alternating sequence. During the second and third runs of the trial, additional participants were distributed to groups because of high dropout rates. This ensured that the total number of participants would be similar in each group at the end of the study. In the second and third bout a quasi-randomized component was not implemented to ensure sufficient adherence to the program which represents a frequent methodological barrier in diet and exercise research [30,31,32]. Thus, part of the women was not quasi-randomized but allocated to the exercise or combination group according to their personal convenience. To account for potential confounding factors arising from the allocation process, statistical analyses were applied to assess differences between the groups at baseline. Most scientific workers were blinded to allocation into the exercise and combination group, except for those responsible for the training sessions.

Collection and analysis of blood samples

Blood samples were collected by an experienced nurse both before the intervention and after its completion. After an overnight fast (≥10 h), a sample of 5 mL of blood was collected from both groups in EDTA tubes and used to determine glucose, insulin, total cholesterol, triglycerides, neutrophils, lymphocytes, and platelets via an enzymatic system and an absorbance spectrophotometer. The calculation of the LDL-cholesterol fraction was calculated via the Friedewald formula: [LDL-c = CT-HDL-c-TG/5]. The calculation of the Systemic Immune Inflammation Index (SII) was performed via the following formula: [SII = (neutrophil × platelet)/lymphocyte].

Body composition and anthropometric and blood pressure measurement

Body composition was assessed via an MC-980 Body Composition Analyzer (Tanita, Tokyo, Japan). The scale sends current through the body and measures the resistance of different tissues. This technique is referred to as bioelectrical impedance analysis and is used to estimate body mass (BM) (kg), muscle mass (MM) (kg), fat-free mass (FFM) (kg), fat mass (FM) (kg), fat mass percentage (%FM) (%), and total body water (TBW) (kg). The instructions for participants were as follows: they were required to abstain from alcohol for 1 day prior to the measurement, to urinate just before the measurement, avoid taking any food or liquid for a minimum of 3 h prior to the measurement, to avoid taking any food or liquid for a minimum of 3 h prior to the measurement, and to refrain from excessive eating, drinking or exercising for a minimum of 1 day prior to the measurement.

A nonstretchable, flexible body measuring tape was used to measure waist circumference (WC) and hip circumference (HC). The waist circumference was measured in the horizontal plane at the midpoint between the lowest rib and the iliac crest. The hip circumference was measured at the widest point of the buttocks, with the tape parallel to the floor. Height was measured via a stadiometer. For each participant, the body mass index (BMI) and the waist-to-height ratio (WHtR) were calculated. BMI was calculated via the formula: [BMI = weight [kg]/height [m]2], and WHtR was calculated via the formula: [WHtR = (WC [cm]/height [cm]) × 100].

Peripheral blood pressure measurements were performed via a digital sphygmomanometer. The participants were in a relaxing environment, comfortably seated with their backs and arms supported, feet flat on the ground, legs not crossed, and bladders empty. Data concerning systolic (SBP) (mmHg), and diastolic (DBP) (mmHg) blood pressure were obtained.

Diet protocol

Only the combination group participated in the dietary intervention which involved eating within an 8-h window or less and fasting during the rest of the day. Participants were asked to reduce their daily time window for energy intake to a maximum of 8 h/day. The participants were starting the eating window at a self-selected time. The amount and type of food were also self-selected. The participants were asked not to change the type of food they usually ate. During the fasting period, participants were allowed to consume non-energy-containing beverages. Participants received motivational support to enhance adherence through face-to-face conversations during training sessions. The participants reported the time of their first and last meal each day in an online survey every 7 days. The participants in the exercise group were instructed to maintain their usual eating habits. Before and at the end of the experiment, the participants completed the Dietary Habits, Lifestyle, Food Frequency Consumption and Nutritional Beliefs Questionnaire (KomPAN questionnaire) [33]. KomPAN was used to evaluate the food frequency consumption (FFC) which provides information about the frequency of consumption of the 33 different items, habitual consumption of foods, specific food components or nutrients, and dietary patterns. Ten of the 33 items were labeled as components of the Healthy Diet Index and used to calculate the Pro-Healthy Diet Index and fourteen of these items were labeled as the Unhealthy Diet Index and used to calculate the Non-Healthy Diet Index.

Exercise protocol

Both the combination and exercise groups participated in the exercise intervention. All individuals engaged in a moderate-intensity strength and endurance circuit training program twice per week under supervised conditions for a period of 12 weeks. The exercises of the training program were performed on eight machines that are a part of the MILON system, arranged in the following circuit sequence: cycle ergometer, abdominal crunch, leg curl, latissimus pulldown, elliptical machine, leg press, back extension, and leg abductor. Aerobic exercises were performed on the cycle ergometer and the elliptical machine. Strength exercises were performed on strength training machines and involved abdominal muscles, hamstrings, latissimus dorsi, quadriceps, erector spinae, gluteal muscles. The duration of the exercises was controlled (1 min for strength exercises, 4 min for endurance exercises, and 30-s rest after each exercise. During each session, the participants performed 3 circuit sequences. Training intensity was estimated for each individual via an age-predicted heart rate maximum (HRmax) equation via Fox’s equation (Fox-HRmax = 220 − age). During each training session, a Polar heart rate monitor (Polar USA, Inc., NY) was used to monitor each participant’s heart rate (HR). The intensity load was adjusted based on the monitored HR. According to the American College of Sports Medicine (ACSM), moderate-intensity aerobic exercise is achieved once a person’s heart rate reaches 64–76% of their age-predicted maximal heart rate. Time spent in low, moderate, and high-intensity zones was calculated for each participant to estimate the percentage of time spent in each intensity zone during all training sessions. The intensity of the resistance training was individualized according to the muscle strength level of each participant, which was assessed by the 1 repetition maximum (1RM). The training intensity was increased periodically every 4 weeks. The resistance training load was set at 50% of the 1RM during weeks 1–4, 60% of the 1RM during weeks 5–8, and 70% of the 1RM during weeks 9–12. Each exercise session lasted 55 min. In addition, participants were asked to maintain their regular activity habits. The participants were required to attend a minimum of 90% of the training sessions (at least 22 of 24 training sessions), and any participant who did not meet this threshold was excluded from the final analysis. The exercise intensity and duration were selected based on a review of the literature, which suggested that these parameters optimize cardiometabolic health parameters in sedentary individuals [34].

Statistical analysis

After the assumptions of normality were tested by the Shapiro–Wilk test, the t test was applied in cases of a parametric distribution for comparisons between groups and the paired t test was used for intragroup comparisons. The Wilcoxon test was applied for intragroup comparisons in cases of nonparametric distribution and the Mann–Whitney U test was used for comparisons between groups. The Chi-square tests were used to compare the prevalence of BMI status and menopausal status among each group. The results are expressed as the means ± standard deviations or medians with upper and lower quartiles. Cohen’s d effect size for the paired t test and r =|z|/sqrt(N) for the Wilcoxon test were calculated and interpreted as follows: trivial: <0.20, small: 0.20–0.50, moderate: 0.50–0.80, or large: >0.80 [35, 36]. An ANOVA with a two-way repeated measures mixed model for intra- and intergroup comparisons was performed. When a significant effect was found, post hoc multiple comparisons were performed. Effect size and statistical power were reported when a significant interaction effect was detected. The effect size for ANOVA was assessed using the partial eta-squared (η2) and ranked as follows: ∼0.01 = small effect, ∼0.06 = moderate effect, and ≥0.14 = large effect. Differences with a p value ≤ 0.05 were considered statistically significant. The calculations were performed using STATISTICA 13.3 (StatSoft, Inc.).

Results

Participants

A total of 80 participants were recruited for this study, with an overall dropout rate of 23% by the end of 12 weeks. The reasons for the high dropout rate were the personal situations of the participants and their concerns regarding the COVID-19 pandemic. In total, 62 participants completed the study. The mean age was 51.3 ± 4.69 years. Statistical analysis revealed that a systolic blood pressure was significantly greater in the combination group than in the exercise group at baseline (p = 0.009). No other significant differences between groups at baseline were identified. The mean BMI was 27.26 ± 5.38. There was no significant difference in the mean of BMI between the groups at baseline (p = 0.380). There were 44.1% perimenopausal/menopausal women and 55.9% postmenopausal women in the exercise group. There were 32.1% perimenopausal/menopausal women and 67.9% postmenopausal women in the combination group. No significant differences were observed in the prevalence of women in premenopausal/menopausal or postmenopausal groups between the combination group and the exercise group (p = 0.335). There were no differences between perimenopausal/menopausal and postmenopausal women in the combination group at baseline in the measured outcomes. There were no differences between perimenopausal/menopausal and postmenopausal women in the exercise group at baseline regarding measured outcomes, despite total cholesterol (p = 0.002), non-HDL (p = 0.003), and LDL (p = 0.004) levels, which were higher in postmenopausal women.

Adherence to exercise and/or dietary intervention

A total of 24 sessions were conducted for the training, with both groups completing over 96% of the sessions. The participants were allowed to miss a maximum of 2 out of 24 total sessions. Exercise compliance was assessed by recording attendance at each supervised exercise session. If an exercise session was missed, the participant was required to compensate for the missed session. More than 79% of the participants were exercising at moderate or higher intensity for at least 50% of the time during the sessions. There was no difference in exercise intensity between the groups (p = 0.801). Dietary compliance was assessed by weekly reports. Participants reported the time of the consumption of their first meal and the time of the consumption of their last meal on each day of the week. The length of the eating window in every day was calculated for each participant. The average length of an eating window was calculated for each participant and for both study groups separately. Dietary compliance was lower than exercise compliance, with the combination group adhering to their prescribed 8-h-long eating window for over 62% of the days and adhering to their 9-h eating window for almost 87% of days. During the experiment, the mean length of the eating window was 8 h and 23 min in the combination group. Prior to the experiment, the eating window of the participants was on average 12 h and 26 min long. The KomPAN questionnaire results were calculated to compare the baseline intensity of pro-healthy and non-healthy characteristics and the intensity at the end of the study in both groups. There was no significant difference in food frequency consumption characterized by pro-healthy (p = 0.264) and non-healthy (p = 0.065) intensity before and after the 12-week intervention in the combination group. This suggests that the quality and quantity of food consumed while undergoing TRE remained unaltered when compared with the diet previously consumed by participants prior to the experiment.

Body composition and anthropometric measurements

Values for FM, FFM, MM, TBW (%), TBW (kg), and ECW/TBW at baseline were similar in the exercise and the combination groups. There were no significant changes in body composition outcomes in the exercise group after 12 weeks (Table 1). FM, TBW (%), and ECW/TBW ratio decreased significantly in the combination group after the intervention (Table 1). There was no significant effect of the group × time interaction in body composition outcome measurements (Table 1). There were no differences in BMI, WC, HC, and WHtR between the exercise and combination groups at baseline. The combination of TRE and exercise affected all these indicators, resulting in significant decreases in BMI, WC, HC, and WHtR (Table 1). A significant decrease was observed in the exercise group, although this was limited to HC only (Table 1). There was a significant effect of the group × time interaction on BMI (F(1,60) = 4.482) (Table 1).

Table 1 The effect of diet and/or exercise intervention on cardiometabolic biomarkers
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Blood indicator concentrations and blood pressure

The values for glucose, insulin, and HOMA-IR at baseline were similar in both groups. After 12 weeks, no significant changes were observed in the exercise group. However, the combination group demonstrated a significant reduction in glucose, insulin, and HOMA-IR (Table 1). There was no effect of group × time interaction on these measurements (Table 1). There were no changes in total cholesterol, LDL, HDL, non-HDL, and triglyceride concentrations after 12 weeks (Table 1). The values for the SII were similar in both groups at baseline. The SII decreased significantly in both groups (Table 1). There was no effect of the group × time interaction on the SII (Table 1). SBP was significantly higher in the combination group at baseline (p = 0.009). There was no difference in DBP between the groups at baseline. SBP and DBP decreased significantly in both groups after 12 weeks F(1,58) = 5.082 (Table 1). There was a significant effect of the group × time interaction on SBP (Table 1). However, there were differences between the groups at baseline. There was no effect of the group × time interaction on DBP (Table 1).

Discussion

To our knowledge, the present investigation is the first trial of intermittent fasting and exercise in menopausal participants. The aim of this study was to investigate whether implementing time-restricted eating alongside exercise, as opposed to exercise alone, would have a significant positive effect on cardiometabolic health in menopausal women. Initially, the authors hypothesized that combining TRE with exercise would result in greater improvements in body composition and cardiometabolic health compared to exercise alone. The main finding of the study was that the combination of TRE and exercise did indeed lead to greater improvements in BMI but not in cardiometabolic health markers compared to exercise alone. An additional finding was that the combination group presented significant improvement in a greater number of parameters than the exercise group, with moderate or small effect sizes: e.g., in fat mass, glucose homeostasis markers (glucose level, insulin level, and HOMA-IR), and anthropometric measurements (WC and WHtR).

In the present study, insulin, glucose, and HOMA-IR parameters improved significantly in the combination group after a 12-weeks intervention. The results of this study indicate that combining TRE with physical exercise may lead to improved glycemic control. Fasting dietary interventions appear to improve glucose metabolism and increase fatty-acid metabolism [37]. Nevertheless, fasting glucose levels, fasting insulin levels, and insulin resistance have remained unchanged in studies investigating the effect of TRE with 8-h eating windows [38,39,40]. In the present study, insulin, glucose, and HOMA-IR parameters improved significantly in the combination group. This improvement was possibly due to metabolic adaptations which are regulated by multiple molecules, such as myokines, hepatokines, and adipokines—their levels change in various situations [41]. Adiponectin is an adipokine that has an insulin-sensitizing effect in fat tissue [42]. Moro et al. investigated a similar issue in a group of resistance-trained males who followed 8 weeks of TRE with an 8-h long eating window. They reported a highly significant increase in adiponectin levels [43]. Varady et al. [22] suggested that shorter eating windows, placed earlier in the day, may be required to improve parameters of glycemic control via TRE. The results of this study indicate that combining TRE with physical exercise may also result in improved glycemic control. In the study conducted by Haganes et al., glycated hemoglobin decreased after 7 weeks of high-intensity interval training and TRE with a 10-h long eating window in women with overweight or obesity. However, there were no changes in HOMA-IR2. Given that the 12-week intervention in this study did induce changes in HOMA-IR, it may be possible that 7 weeks is not enough time to observe significant changes in this indicator [44].

There was no significant change in the level of LDL, HDL, non-HDL and triglycerides in either group in this study. However, fasting strategies aligned with the human circadian rhythm have been found to positively influence cardiometabolic health [45]. Moreover, intermittent fasting provides superior improvement in cardiometabolic health compared with continuous energy restriction [14]. In a study group of middle-aged participants who followed 6 months of ADF, their LDL cholesterol and triglyceride levels were reduced [46]. However, LDL cholesterol levels, HDL cholesterol levels, and triglyceride levels remained unchanged in trials of 12 weeks of 16:8 TRE [38,39,40]. These results are similar to the results of this study. It is likely that a greater amount of time would be required to observe consistent changes in lipid panel parameters with IF.

The decrease in systolic and diastolic blood pressure was significantly greater in the combination group than in the exercise group in this study. The results of the studies investigating the effects of TRE on blood pressure vary, with some studies reporting decreases in blood pressure [39, 47] and others reporting no effect [38, 48]. Gabel et al. [39] reported a significant decrease in systolic blood pressure and no changes in diastolic blood pressure. In this study, the hypotensive effect was significantly greater in the combination group, suggesting that adding TRE to regular physical activity as a preventive measure may significantly contribute to reducing cardiovascular risk in menopausal women. IF has been reported to restore the circadian rhythm of blood pressure in diabetic mice by inhibiting sympathetic activity, resulting in a cardiovascular protective effect [20]. Interestingly, in this study, the reduction in systolic blood pressure was greater than the reduction in diastolic blood pressure in the combination group, indicating that TRE has a stronger effect on systolic blood pressure. Our observation was similar to the results discussed in the meta-analysis by Wang et al. [49]. However, interpreting the results of SBP in this study is challenging, as SBP was significantly higher in the combination group at baseline.

There were no significant improvements in body composition, glucose levels, insulin levels, insulin resistance biomarkers or lipid panel parameters in the exercise group. Multicomponent exercise mode that was utilized in this study engages both the cardiovascular and the musculoskeletal system during a single exercise session using both resistance and aerobic exercises. This type of exercise has been proven to be more effective than continuous endurance training or resistance training for improving cardiometabolic health [50]. The effect of body and mind strategies such as tai chi on metabolic health is similar to the effect of resistance training [51] and walking [52]. Although the exercise method used in this study has been proven to be one of the most effective for improving cardiometabolic health, there were no changes in body composition, glucose level, insulin level, HOMA-IR, and lipid panel parameters in the exercise group. Similarly, Dupuit et al. [23] reported no changes in BMI, WC, FM (kg), FM (%), FFM, MM, glucose, insulin, HOMA-IR, total cholesterol, HDL-C, LDL-C, or TG in postmenopausal women with overweight/obesity after a 12-week training program of high-intensity interval training and resistance training conducted 3 times a week for 45 min. Isenmann et al. [53] reported that 2 resistance training sessions per week over 10 weeks at 50% 1-RM intensity did not cause significant changes in BMI or body composition in premenopausal and postmenopausal women. The results of this study are similar, as there was no change in these parameters in the exercise group. In the study conducted by Nio et al. [54] premenopausal women experienced a greater increase in maximal aerobic capacity than postmenopausal women did after 12 weeks of high-intensity interval training, which may indicate that menopause may reduce positive adaptations to physical exercise. In this study, blood pressure and hip circumference improved significantly in the exercise group, indicating that the resistance and aerobic circuit training program is effective in improving cardiometabolic health in menopausal women, but the effects on body composition and glucose/insulin levels are not as pronounced as those observed in patients with medical conditions such as type 2 diabetes [55].

In this study, fat mass decreased significantly, and lean body mass remained unchanged in the combination group. There were no significant changes in body composition in the exercise group. A systematic review and meta-analysis evaluating the influence of intermittent fasting combined with resistance training on body composition outcomes demonstrated significant decreases in body mass, fat mass, body mass index, and body fat percentage with no significant effect on fat-free mass [24]. Another systematic review also confirmed that intermittent fasting paired with resistance training maintains lean body mass and promotes fat loss, simultaneously [25]. This finding is consistent with the results of this study, where it appears that TRE did not reduce lean body mass, although BMI decreased significantly more in the combination group than in the exercise group. Intermittent fasting and continuous calorie restriction have been shown to produce similar weight loss outcomes. However, IF has demonstrated a superior ability to preserve lean body mass [56]. It is hypothesized that the effectiveness of IF in fat loss is attributed not only to calorie restriction, but also to the production of ketone bodies and enhanced lipid metabolism. Fasting optimizes the use of cellular energy sources, prioritizing ketone bodies and fatty acids over glucose [57]. While IF has been shown to improve BMI, it does not affect sex hormone levels in women [58, 59]. Therefore, changes in sex hormone levels cannot explain the beneficial effect on BMI observed in this study.

In this study, no significant changes in WC or WHtR were observed in the exercise group. However, there was a significant decrease in these measures in the combination group. Similarly, a systematic review and meta-analysis comparing the combined effects of intermittent fasting and exercise on cardiometabolic health found that the combination of these two strategies resulted in greater changes in waist circumference than exercise alone does [26]. WHtR, as well as WC, are predictors of diabetes, hypertension and cardiovascular disease [60]. Therefore, the combination of TRE and exercise might be an effective strategy for the prevention of these health conditions.

In this study, the ECW/TBW decreased significantly in the combination group, indicating an improvement in fluid balance after undergoing TRE and exercise. No change in ECW/TBW was observed in the exercise group. The ECW to TBW ratio is a fluid imbalance marker known to be associated with hypertension [61]. Therefore, it may be suggested that the combination of TRE and exercise demonstrates potential hypotensive effect.

The Systemic Immune-Inflammation Index (SII) is a potential inflammation-based biomarker of cardiovascular diseases, as individuals with higher SII have an increased risk of cardiovascular disease [62]. In this study, the SII was significantly reduced in the exercise group. Joisten et al. [63] reported that 3 weeks of high-intensity interval training (HIIT) performed 3 times per week significantly decreased the SII among older men and women. This finding is consistent with the results of our study. A decrease in the SII was also present in the combination group. This is the first study to investigate the effect of diet on the SII. Fasting activates autophagy and defense mechanisms against oxidative and metabolic stress and suppresses inflammation [64].

Although a significant group × time effect was observed for BMI and SBP only, notably, there were significant effects of the intervention on most of the variables in the combination group. These findings show the direction for future studies which could investigate the effect of combined exercise and TRE interventions with different control groups in larger study samples and control for a larger number of covariates, such as BMI or specific menopausal phases. This study, along with future studies in this field, may contribute to the development and verification of appropriate health recommendations for middle-aged women.

The results of this study highlight the clinical significance of TRE and exercise interventions in the prevention of cardiometabolic disease. Based on the findings of a meta-analysis by Canoy et al. [65], even modest blood pressure reduction can lead to meaningful gains in the prevention of cardiovascular disease, and for each 5-mmHg reduction in systolic blood pressure, the risk of developing cardiovascular events fell by 10%. In this study, a median reduction in systolic blood pressure of 10 mmHg was observed in the combination group. This represents a 9% reduction in SBP from baseline. Presumably, this reduction is associated with an approximately 20% decrease in the risk of developing cardiovascular events in the future. According to Wainberg et al. [66], a reduction in BMI of 1 kg/m2 was associated with a 1.37-fold reduction in diabetes odds in non-overweight individuals and with 1.21-fold reduction in diabetes odds in individuals with obesity. In this study, a median BMI reduction of 0.8 kg/m2 was achieved in the combination group over a 12-week period. This decrease is clinically significant, as it presumably corresponds to 14–22% reduction in risk of developing diabetes. These results underscore clinical significance of TRE combined with exercise for the prevention of diabetes and cardiovascular disease. Notably, the results retained clinical significance despite relatively low diet protocol adherence and high dropout rates.

The results of this study have the potential to be applicable to different populations and cultural backgrounds. However, further research in diverse cohort is warranted to confirm these findings. Fasting in an integral part of religious and ethnic cultures [67]. The results were clinically significant even though fasting does not align with the cultural practises of the women who participated in this study. This suggests that individuals from various cultural backgrounds may still benefit from fasting interventions. The findings of this study support the development of lifestyle guidelines that include exercise and time-restricted eating recommendations to improve cardiometabolic health in menopausal women. It is crucial to simultaneously adapt exercise and fasting interventions to increase the effectiveness of public health interventions.

There are several limitations of the study. Our inclusion criteria may have resulted in selection bias with a broad age at menopause as a confounding factor. Additionally, the level of sex hormones was not measured, and the menopausal phase was self-reported. The levels of these hormones could explain the participants’ response to exercise and diet and could objectively indicate the menopausal phase. Another limitation is that the intervention lasted only 3 months, and the observed effects may not persist over the long-term. Diet-plus-exercise programs are associated with partial weight regain. Possible regain was not investigated in this study. The lack of energy intake data does not allow to observe a potential effect of energy restriction on the study outcomes. Moreover, our sample size is quite limited. Further studies with larger samples are needed to clarify the appropriate doses of fasting and exercise interventions for improving metabolic health in menopausal women.

Conclusions

The present study demonstrated that the combination of time-restricted eating and exercise resulted in superior improvements in BMI, though not in markers of cardiometabolic health, compared to exercise alone in menopausal women. The combination of time-restricted eating and exercise may serve as an effective strategy for preventing conditions commonly associated with menopause, such as obesity, hypertension, and insulin resistance.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

%FM:

Fat mass percentage

1RM:

1 Repetition maximum

ADF:

Alternate-day fasting

BM:

Body mass

BMI:

Body mass index

DBP:

Diastolic blood pressure

ECW/TBW:

Extracellular water to total body water ratio

FFC:

Food frequency consumption

FFM:

Fat-free mass

FM:

Fat mass

HC:

Hips circumference

HDL:

High-density lipoprotein

HOMA-IR:

Homeostatic model assessment for insulin resistance

HRmax:

Heart rate maximum

IF:

Intermittent fasting

LDL:

Low-density lipoprotein

METs:

Metabolic equivalents

MM:

Muscle mass

Non-HDL:

Non-high-density lipoprotein

SBP:

Systolic blood pressure

SII:

Systemic immune-inflammation index

TBW:

Total body water

TRE:

Time-restricted eating

WC:

Waist circumference

WHtR:

Waist-to-height ratio

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Acknowledgements

We would like to thank the kravter Sp. Z o. o. (exclusive distributor for the MILON company products in Poland) for providing exercise equipment, as well as the participants of the study for taking part in the experiment.

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Authors and Affiliations

  1. Department of Physical Activity and Health Promotion Science, Poznan University of Physical Education, 61-871, Poznan, Poland

    Beata Jóźwiak & Ida Laudańska-Krzemińska

  2. Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medical Sciences, 60-355, Poznan, Poland

    Remigiusz Domin

  3. Department of Cardiological and Rheumatological Rehabilitation, Poznan University of Physical Education, 61-871, Poznan, Poland

    Monika Krzywicka

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Contributions

BJ has made substantial and major contribution to the conception and design of the work, the acquisition, analysis, and interpretation of data, has drafted the work and substantively revised it. RD has made substantial contribution to the acquisition and analysis of data and has substantively revised the work, MK has made substantial contribution to acquisition and analysis of data, ILK has made substantial contribution to the design of the work, the acquisition, analysis, and interpretation of data and has substantively revised the work. All authors read and approved the final version of the manuscript and have agreed both to be personally accountable for author’s own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature.

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Correspondence to Beata Jóźwiak.

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Jóźwiak, B., Domin, R., Krzywicka, M. et al. Effect of exercise alone and in combination with time-restricted eating on cardiometabolic health in menopausal women. J Transl Med 22, 957 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12967-024-05738-y

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