High Intensity Resistance Training + Creatine in Perimenopause

Completed · Not applicable · Has a placebo group

Conditions studied: Perimenopause

In brief

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.

Key facts

Study ID

NCT07027800

Run by

University of North Carolina, Chapel Hill

People needed

55

Starts

2025-06-02

Expected to finish

2025-12-15

Last updated by the study team

2026-03-11

Who can join

Age: 38 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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 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 it is running

• Applied Physiology Laboratory — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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