High Intensity Resistance Training + Creatine in Perimenopause
NCT ID: NCT07027800
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
51 participants
INTERVENTIONAL
2025-06-02
2026-08-01
Brief Summary
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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.
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Detailed Description
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Skeletal muscle health, critical for lifelong function, often begins to decline during PERI. While resistance training is known to improve muscle strength and body composition in older women, limited research has focused specifically on the PERI stage. High-intensity resistance training (HIRT) offers a time-efficient strategy to address these issues. Creatine monohydrate (CM) supplementation, traditionally used to enhance muscle performance, has shown potential benefits for cognitive function, mood, fatigue reduction, and overall metabolic health-effects particularly relevant to PERI women.
This pilot study aims to evaluate the preliminary effects of six weeks of HIRT, with or without CM supplementation, on muscle characteristics, brain health, and metabolism in women around PERI age. The study uses a randomized, double-blind, placebo-controlled design with broad inclusion criteria to enhance generalizability. Participants will undergo a 5-day supplementation phase followed by a 6-week training phase. Outcomes will include assessments of muscle quality and strength, cognitive function, brain oxygenation, metabolic rate, and protein turnover, while accounting for hormonal fluctuations.
This trial will provide foundational data to inform a larger, more comprehensive study and aims to identify effective, accessible interventions to support health and quality of life in women during the menopause transition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Creatine Monohydrate
20 g Creatine Monohydrate for 5 days followed by 5 grams creatine monohdyrate daily + 2 x weekly high intensity resistance training
Creatine Monohydrate
20 gram loading of creatine monohdyrate for 5 days, followed by 5 grams per day for 6 weeks
Placebo
20 g Non-Caloric Placebo followed by 5 grams daily placebo + 2 x weekly high intensity resistance training
Placebo
20 grams daily of non-caloric placebo + 5 grams daily non-caloric placebo for 6 weeks
Control
No exercise or supplement provided
No interventions assigned to this group
Interventions
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Creatine Monohydrate
20 gram loading of creatine monohdyrate for 5 days, followed by 5 grams per day for 6 weeks
Placebo
20 grams daily of non-caloric placebo + 5 grams daily non-caloric placebo for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
38 Years
60 Years
FEMALE
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Abbie Smith-Ryan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carollina at Chapel Hill
Locations
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Applied Physiology Laboratory
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Research Coordinator
Role: CONTACT
Facility Contacts
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Other Identifiers
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24-3202
Identifier Type: -
Identifier Source: org_study_id
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