Metabolic Effects of Perimenopause

Last updated: January 24, 2025
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Non-caloric Placebo water

Whey Protein Isolate

Clinical Study ID

NCT06098183
23-2338
  • Ages 38-60
  • Female
  • Accepts Healthy Volunteers

Study Summary

Starting in early-perimenopause, changes in systemic and tissue level metabolism result in an accelerated loss of muscle mass and an increase in body fat. Our preliminary work indicates that metabolic alterations, specifically a decrease in whole-body protein balance, increase in abdominal adiposity, and reduced metabolic flexibility during exercise is most evident in perimenopause. Exercise is a potent stimulator of skeletal muscle insulin sensitivity. High intensity interval training (HIIT) has been shown to be an effective exercise strategy to support cardiometabolic health in overweight and obese young women. Skeletal muscle is critical to maintaining metabolic health and functionality across the lifespan, and is considered the primary diver of whole-body insulin resistance.There is a significant decrease in muscle mass across the menopause transition, which is often exacerbated by a significant gain in fat mass and visceral fat. Protein consumption prior to HIIT has resulted in improvements in energy expenditure and fat oxidation in young women. The overarching objective of this study is to determine the metabolic response of HIIT compared to traditional aerobic exercise in early and late perimenopausal women. Aim 1 will examine the metabolic responses (glucose, insulin sensitivity, energy expenditure) of HIIT vs aerobic exercise, combined with pre-exercise carbohydrate or protein ingestion, in overweight/obese (BMI: 28-40 Kg/m^2) early and late perimenopausal women. Aim 2 will explore the impact of perimenopause on the fat oxidation and protein turnover before and after exercise. Lastly, aim 3 will explore the modulating effect of intramuscular fat on these metabolic outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Early and late perimenopausal women (≥38 years; early: experienced menstrualbleeding in the previous 3 months with a decrease in cycle regularity in the pastyear; late: no menstrual bleeding in the previous 3 months with some bleeding in theprevious year).

  • Overweight and obese: body mass index (BMI) of 28 - 40 Kg/m^2 and percent body fat (%BF) ≥ 30%.

  • Healthy, non-smokers.

Exclusion

Exclusion Criteria:

  • Have current and/or history of cardiovascular disease, diabetes, metabolic, thyroid,pulmonary, renal, hepatic, gastrointestinal, musculoskeletal disorders or medical orsurgical events, such as bariatric surgery, heart surgery, or any joint ormusculoskeletal 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 theprevious 6 months.

  • Taking metabolism-altering drugs or medications outside of estrogen replacementtherapy 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 pregnancytest)

  • Currently nursing or have had a child within the previous 6 months

  • Has participated in another clinical trial within four weeks prior to enrollmentthat 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 fromcaffeine, tobacco, alcohol, and physical activity before testing days.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Non-caloric Placebo water
Phase:
Study Start date:
March 22, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Applied Physiology Laboratory - University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.