Trial Summary
What is the purpose of this trial?This trial aims to compare the effects of high-intensity interval training (HIIT) and traditional aerobic exercise on metabolism in overweight or obese women going through perimenopause. The study will also look at how eating protein or carbohydrates before exercise affects these outcomes. The goal is to understand how these exercises and dietary choices can help manage weight and improve metabolic health during perimenopause. High-intensity interval training (HIIT) has been shown to significantly decrease body weight and fat mass, with more pronounced effects in premenopausal women.
Is pre-exercise protein a promising treatment for perimenopausal women?Yes, pre-exercise protein, especially milk basic protein (MBP), is promising for perimenopausal women as it can help increase bone mineral density by promoting bone formation and reducing bone loss.458911
Do I need to stop taking my current medications for the trial?Yes, you may need to stop taking certain medications. The trial excludes participants taking metabolism-altering drugs or medications outside of estrogen replacement therapy, such as corticosteroids, stimulants, insulin, thyroid medications, or phytoestrogens.
What safety data exists for pre-exercise protein treatment in perimenopausal women?The provided research does not contain specific safety data for pre-exercise protein treatments such as Whey Protein Isolate (WPI) or Non-caloric Placebo water in perimenopausal women. The studies focus on soy protein and isoflavones, which are different from the treatment in question.12367
What data supports the idea that Pre-Exercise Protein for Perimenopause is an effective treatment?The available research shows that milk whey protein, particularly its basic protein fraction, can increase bone mineral density in perimenopausal women by promoting bone formation and reducing bone breakdown. This suggests that Pre-Exercise Protein, which includes whey protein isolate, may be effective in supporting bone health during perimenopause. However, there is no direct comparison to other treatments for perimenopausal symptoms in the provided data.234510
Eligibility Criteria
This trial is for early and late perimenopausal women aged 38 or older who are overweight (BMI: 28-40) with a body fat percentage of 30% or higher. They must be non-smokers, not currently pregnant or nursing, and have had changes in menstrual cycle regularity. Women with cardiovascular, metabolic disorders, recent weight fluctuations, or those on certain medications cannot participate.Exclusion Criteria
I have been diagnosed with or believe I have an eating disorder.
I have high blood pressure that isn't managed or an abnormal heart rhythm.
I have gained or lost more than 5 kg in the last 2 months.
I have been diagnosed with PCOS.
I had a hysterectomy to manage menopause symptoms.
Treatment Details
The study tests how high intensity interval training (HIIT) versus traditional aerobic exercise affects metabolism in perimenopausal women when combined with pre-exercise consumption of either carbohydrates or protein. It aims to understand the impact on glucose levels, insulin sensitivity, energy expenditure, fat oxidation and muscle mass during this life stage.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Whey protein isolate, then Non-caloric placeboExperimental Treatment2 Interventions
Participants will randomly consume a whey protein isolate (Dymatize ISO-100) mixed with 6 oz of water prior to exercise. After a minimum of 48 hrs they will consume a non-caloric placebo (6 oz of water) prior to exercise.
Group II: Non-caloric placebo, then Whey protein isolatePlacebo Group2 Interventions
Participants will randomly consume a non-caloric placebo (6 oz of water) prior to exercise. After a minimum of 48 hrs they will consume a whey protein isolate (Dymatize ISO-100) mixed with 6 oz of water prior to exercise.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Applied Physiology Laboratory - University of North CarolinaChapel Hill, NC
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
American Diabetes AssociationCollaborator
References
Isoflavone-rich soy protein isolate attenuates bone loss in the lumbar spine of perimenopausal women. [2018]No published studies have directly examined the effect of soy protein with isoflavones on bone or bone turnover in perimenopausal women.
Isoflavone-rich or isoflavone-poor soy protein does not reduce menopausal symptoms during 24 weeks of treatment. [2019]We examined the change in menopausal symptoms in response to 24 weeks of isoflavone-rich (80.4 mg/day) and isoflavone-poor (4.4 mg/day) soy protein isolate treatment in perimenopausal women.
Effect of a combination of isoflavones and Actaea racemosa Linnaeus on climacteric symptoms in healthy symptomatic perimenopausal women: a 12-week randomized, placebo-controlled, double-blind study. [2021]To investigate the effects of a novel dietary supplement containing soy isoflavones and Actaea racemosa Linnaeus (formerly called Cimicifuga racemosa L.) on climacteric symptoms in healthy perimenopausal women.
[Prevention of osteoporosis by foods and dietary supplements. Milk basic protein (MBP) increases bone mineral density in young adult women and perimenopausal women]. [2015]Milk has beneficial effects on bone health than other food sources. Recent in vitro and in vivo studies have shown that milk whey protein, especially its basic protein fraction (milk basic protein: MBP), contains components capable of promoting bone formation and inhibiting bone resorption. We tried to examine the effect of MBP on bone mineral density (BMD) and markers of bone metabolism in healthy young adult women and perimenopausal women. In the healthy young women study, we found that MBP increased BMD, by promoting bone formation and inhibiting bone resorption. In the healthy perimenopausal women study, we also found that MBP increased BMD, primarily by inhibiting bone resorption, while maintaining bone formation. Thus, bone remodeling balances become positive that leads to maintenance or increase of bone formation. MBP supplementation could be effective for bone health in a wide range of generation especially those who hate to drink milk.
Acute effects of whey protein isolate on cardiovascular risk factors in overweight, post-menopausal women. [2015]The purpose of this study was to investigate the acute effects of dietary whey proteins on lipids, glucose and insulin, and resting energy expenditure in overweight and obese post-menopausal women, a population highly susceptible to cardiovascular disease.
Soy use and vasomotor symptoms: Soy Estrogen Alternative follow-up study. [2021]To evaluate vasomotor symptoms and soy and hormone therapy use in women who had previously participated in the Soy Estrogen Alternative (SEA) study, a trial conducted to compare the effects of soy protein supplements containing differing levels of isoflavones on menopausal symptoms, chronic disease risk factors, and health-related quality of life in perimenopausal and postmenopausal women.
The effect of Qigong on menopausal symptoms and quality of sleep for perimenopausal women: a preliminary observational study. [2022]The study objectives were to examine the effect of a 12-week 30-minute-a-day Ping Shuai Qigong exercise program on climacteric symptoms and sleep quality in perimenopausal women.
Whey protein and high-volume resistance training in postmenopausal women. [2018]To examine the combined effects of whey protein supplementation and low intensity, high-volume resistance training in healthy postmenopausal women.
Effect of gender on the acute effects of whey protein ingestion on energy intake, appetite, gastric emptying and gut hormone responses in healthy young adults. [2020]Protein supplements, usually drinks rich in whey protein, are used widely for weight loss purposes in overweight adults. Information comparing the effects of whey protein on appetite and energy intake in men and women is limited. The objective was to compare the acute effects of whey-protein intake on energy intake, appetite, gastric emptying and gut hormones in healthy young men and women.
Dietary and Exercise Interventions for Perimenopausal Women: A Health Status Impact Study. [2022]To explore the impact of different intervention methods on physical health indexes of perimenopausal women.
Effect of Whey Protein Supplementation in Postmenopausal Women: A Systematic Review and Meta-Analysis. [2022](1) Background: Whey protein (WP) in combination with resistance training (RT) is beneficial in improving sarcopenic obesity and its damaging effects in older adults, while the difference between men and women should be considered while interpreting results. This review aims to investigate WP's efficacy on postmenopausal women with or without RT; (2) Material and Methods: We searched electronic databases including PubMed, EMBASE, and the Cochrane Library from inception to August 2021 for randomized controlled trials that included comparison groups to evaluate WP's efficacy in women aged 55 years and above. The outcomes included body composition, muscular strength, functional capacity, and dietary intake. Standardized mean differences (SMDs) with 95% confidence intervals (CIs) were used to estimate the effect of WP. We also performed subgroup analysis with or without RT; (3) Results: We included 14 studies in the systematic review and 10 studies in the meta-analysis. Subgroup analyses showed RT was a major confounder for muscle strength, lean mass, and dietary protein intake (PI). In the RT subgroup, WP supplementation had a significant positive effect on biceps curl strength (BC) (SMD: 0.6805, 95% CI: 0.176, 1.185, I2: 0%), and lower limb lean-mass (LLLM) (SMD: 1.103, 95% CI: 0.632, 1.574, I2: 14%). In the subgroup without RT, a significant negative effect on PI (SMD: -0.4225, 95% CI: -0.774, -0.071, I2: 47%) was observed, while no significant effect on muscle strength or lean mass was revealed. WP supplementation did not show a significantly different effect on fat mass or body weight loss in both the subgroups; (4) Conclusions: In postmenopausal women, WP supplementation only in combination with RT enhances BC and LLLM compared to placebo controls. Without RT, WP has no significant benefit on muscle strength or lean mass.