CompletedNot Applicable

High Intensity Resistance Training + Creatine in Perimenopause

United States55 participantsStarted 2025-06-02

Plain-language summary

Purpose: The aims of the study are to investigate the effects of high-intensity resistance training (HIRT) with or without creatine monohydrate (CM) supplementation on three key areas: muscle characteristics, brain health, and metabolism/protein dynamics. Participants: 51 healthy, perimenopausal women between 38-60 years old. Procedures: In a randomized double-blind, placebo-controlled design, participants will either consume creatine (CM), a placebo (PL), or no supplement (CON). CM and PL groups will be assigned a HIRT protocol, and the CON will do no training.

Who can participate

Age range

38 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women transitioning through perimenopause (defined by the North American Menopause Society Menopause Health Questionnaire), with or without hormone therapy or experiencing two or more perimenopause-related symptoms, as determined from the validated North American Menopause Society * Women ≥38-60 yrs. * Recreationally active \[(≥30 minutes of moderate-intensity physical activity per week and \<3 times per week of progressive resistance training, as defined by the International Physical Activity Questionnaire (IPAQ)\] * Body mass index of 18.5-34.9 kg/m\^2 * Is at risk or has a current chronic disease that is not contraindicated by exercise, and could be improved by resistance exercise (i.e. type 2 diabetes, heart disease, hypertension, hypercholesterolemia, hyperthyroidism, depression, osteoporosis, etc.) Exclusion Criteria: * Experienced a musculoskeletal injury within the past three months that inhibits participation in the study. * Has chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer * Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids). * Currently using creatine monohydrate or other performance-enhancing supplements * Has a self-identified or clinically diagnosed eating disorder * 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 part…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Muscle quality

Timeframe: Baseline to after 6 weeks of resistance training and supplementation

Muscle Strength

Timeframe: Baseline to post 6 weeks of resistance training and supplementation

Trial details

NCT IDNCT07027800

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-15

View on ClinicalTrials.gov More Perimenopause trials