Effects of exercise and protein on metabolism during perimenopause
Metabolic Effects of Muscle and Exercise Across Perimenopause
This study is testing if combining high-intensity exercise with protein shakes can help overweight and obese women going through perimenopause improve their metabolism and manage changes in muscle and body fat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 38 Years to 60 Years |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06098183 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolic changes that occur during perimenopause, focusing on the loss of muscle mass and increase in body fat. It aims to assess the impact of high-intensity interval training (HIIT) combined with whey protein isolate on improving metabolic health in overweight and obese women experiencing perimenopause. Participants will be monitored for changes in muscle mass, body fat, and insulin sensitivity. The study seeks to provide insights into effective interventions for managing metabolic health during this transitional phase.
Who should consider this trial
Good fit: Ideal candidates are early and late perimenopausal women aged 38 and older who are overweight or obese.
Not a fit: Patients with significant cardiovascular, metabolic, or musculoskeletal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve metabolic health and reduce the risk of obesity-related conditions in perimenopausal women.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Early and late perimenopausal women (≥38 years; early: experienced menstrual bleeding in the previous 3 months with a decrease in cycle regularity in the past year; late: no menstrual bleeding in the previous 3 months with some bleeding in the previous year). * Overweight and obese: body mass index (BMI) of 28 - 40 Kg/m\^2 and percent body fat (%BF) ≥ 30%. * Healthy, non-smokers. Exclusion Criteria: * Have current and/or history of cardiovascular disease, diabetes, metabolic, thyroid, pulmonary, renal, hepatic, gastrointestinal, musculoskeletal disorders or medical or surgical events, such as bariatric surgery, heart surgery, or any joint or musculoskeletal injuries or surgeries occurring in the 6-months prior to enrollment, that may significantly influence study outcomes or prevent safe participation. * Gained or lost \>5 kg in the previous 2 months * Have a self-identified or clinically diagnosed eating disorder * Undergone a full or partial hysterectomy for treatment of menopausal symptoms * Have uncontrolled hypertension or an abnormal electrocardiogram. * Have an ongoing diagnosed mental disorder with a change in medication in the previous 6 months. * Taking metabolism-altering drugs or medications outside of estrogen replacement therapy that may influence study outcomes (i.e. corticosteroids, stimulants, insulin, thyroid medications) or phytoestrogens. * Diagnosed with polycystic ovarian syndrome (PCOS). * Participating in more than 75 minutes per week of moderate exercise per week. * Currently pregnant or planning to become pregnant (determined from urine pregnancy test) * Currently nursing or have had a child within the previous 6 months * Has participated in another clinical trial within four weeks prior to enrollment that in the opinion of the PI would influence the results. * Has severely impaired hearing or speech or inability to speak English. * Unwilling or unable to comply with the study protocol, including abstaining from caffeine, tobacco, alcohol, and physical activity before testing days.
Where this trial is running
Chapel Hill, North Carolina
- Applied Physiology Laboratory - University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Abbie Smith-Ryan, PhD — University of North Carolina
- Study coordinator: Abbie Smith-Ryan, PhD
- Email: abbiesmith@unc.edu
- Phone: 919-962-2574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.