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NCT06098183: MAAP
Metabolic Effects of Perimenopause
NA trial testing Whey Protein Isolate in Perimenopausal Disorder in 28 participants. Completed in 8 August 2025.
8 August 2025
Quick facts
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 28 |
| Start date | 22 March 2024 |
| Primary completion | 8 August 2025 |
| Estimated completion | 8 August 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Whey Protein Isolate
- Non-caloric Placebo water
Conditions studied
- Perimenopausal Disorder — all drugs for Perimenopausal Disorder →
Sponsor
University of North Carolina, Chapel Hill
Who can join
Adults 38 to 60, female only, with Perimenopausal Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06098183
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Whey Protein Isolate
Trials testing the same drug.
- NCT03154606 — The Effects of Protein Source on Appetite Control, Satiety, and Subsequent Food Intake · NA · completed
Other recruiting trials for Perimenopausal Disorder
Currently open trials in the same condition.
- NCT06419972 — Multimodal Program for Climacteric Women · NA · recruiting
Other University of North Carolina, Chapel Hill trials
Trials by the same sponsor.
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- NCT07383428 — The INICIO-Guatemala Study · NA · not yet recruiting
- NCT07528443 — Ultraprocessed Foods in Colombia · NA · not yet recruiting
- NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
- NCT07534254 — Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06098183 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
- Last refreshed: 11 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06098183.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing