PerimenopausePERIHIRTNCT07027800
High Intensity Resistance Training + Creatine in Perimenopause
A study testing Creatine Monohydrate in people with Perimenopause, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 38 to 60 years, women only
- Conditions the study is for
- Perimenopause
- What is being tested?
- Creatine Monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Physiology Laboratory
Chapel Hill, North Carolina, 27713
About this study
Official title: Effects of High-intensity Resistance Training and Creatine Supplementation on Muscle Quality and Cognition in Perimenopausal Women: a Pilot Study
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.
Read the detailed description
Over one million women in the U.S. transition through menopause each year, a phase marked by significant hormonal fluctuations (estrogen, progesterone, luteinizing hormone) and associated with increased cardiometabolic and cardiovascular risks. Research from our lab has identified key metabolic disruptions during the perimenopausal (PERI) period, including reduced protein balance, increased abdominal fat, decreased strength, and impaired metabolic flexibility. Additionally, women as early as age 35 may experience menopause-related symptoms such as cognitive decline, mood disturbances, and sleep disruptions.
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
- Perimenopause
- Being tested
- Creatine Monohydrate, Placebo
- Keywords
- resistance training, muscle mass, hormone health, creatine monohydrate, exercise, nutrition, womens health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
20 gram loading of creatine monohdyrate for 5 days, followed by 5 grams per day for 6 weeks
PlaceboDietary supplement
20 grams daily of non-caloric placebo + 5 grams daily non-caloric placebo for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Creatine Monohydrate | Experimental | 20 g Creatine Monohydrate for 5 days followed by 5 grams creatine monohdyrate daily + 2 x weekly high intensity resistance training Receives: Dietary Supplement: Creatine Monohydrate |
| Placebo | Placebo comparator | 20 g Non-Caloric Placebo followed by 5 grams daily placebo + 2 x weekly high intensity resistance training Receives: Dietary Supplement: Placebo |
| Control | No intervention | No exercise or supplement provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle quality
Muscle quality measured by echo intensity via ultrasound
Measured: Baseline to after 6 weeks of resistance training and supplementation
Muscle Strength
Maximal strength from 1 repetition maximum for leg press
Measured: Baseline to post 6 weeks of resistance training and supplementation
Secondary outcomes (3)
Menopausal Symptoms
Greene climacteric Scale, 21 questions, scores ranging from 0-63, with higher number indicating greater symptom severity.
Measured: Baseline to post 6 weeks of resistance training + supplementation
Resting metabolic rate
Resting metabolic rate determined from indirect calorimetry
Measured: Baseline to post 6 weeks of resistance training + supplementation
Inventory of Depression and Anxiety
Inventory of Depression and Anxiety Symptoms (IDAS) questionnaire is based on a 5-point Likert scale, ranging from 'not at all' to 'extremely', scores ranging 0-63, with a higher score indicating more severe symptoms.
Measured: Baseline to post 6 weeks of resistance training + supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start2 Jun 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carollina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027800
- Sponsor's protocol ID
- 24-3202
- Acronym
- PERIHIRT
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is pilot data and therefore may not be powered for secondary analyses
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Resistance Training and Creatine Supplementation on Muscle Quality and Cognition in Perimenopausal Women: a Pilot Study
- ClinicalTrials.gov ID
- NCT07027800
- Acronym / sponsor ID
- PERIHIRT / 24-3202
- Conditions
- Perimenopause
- Keywords
- resistance training, muscle mass, hormone health, creatine monohydrate, exercise, nutrition, womens health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over one million women in the U.S. transition through menopause each year, a phase marked by significant hormonal fluctuations (estrogen, progesterone, luteinizing hormone) and associated with increased cardiometabolic and cardiovascular risks. Research from our lab has identified key metabolic disruptions during the perimenopausal (PERI) period, including reduced protein balance, increased abdominal fat, decreased strength, and impaired metabolic flexibility. Additionally, women as early as age 35 may experience menopause-related symptoms such as cognitive decline, mood disturbances, and sleep disruptions.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Creatine Monohydrate | Experimental | Dietary Supplement: Creatine Monohydrate20 g Creatine Monohydrate for 5 days followed by 5 grams creatine monohdyrate daily + 2 x weekly high intensity resistance training |
| Placebo | Placebo comparator | Dietary Supplement: Placebo20 g Non-Caloric Placebo followed by 5 grams daily placebo + 2 x weekly high intensity resistance training |
| Control | No intervention | –No exercise or supplement provided |
Who may qualify
- Ages
- 38 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine Monohydrate20 gram loading of creatine monohdyrate for 5 days, followed by 5 grams per day for 6 weeks | Dietary supplement | Creatine Monohydrate |
| Placebo20 grams daily of non-caloric placebo + 5 grams daily non-caloric placebo for 6 weeks | Dietary supplement | Placebo |
Primary outcome
Muscle quality
Time frame: Baseline to after 6 weeks of resistance training and supplementation
Muscle quality measured by echo intensity via ultrasound
Muscle Strength
Time frame: Baseline to post 6 weeks of resistance training and supplementation
Maximal strength from 1 repetition maximum for leg press
3 secondary outcomes
Menopausal Symptoms
Time frame: Baseline to post 6 weeks of resistance training + supplementation
Resting metabolic rate
Time frame: Baseline to post 6 weeks of resistance training + supplementation
Inventory of Depression and Anxiety
Time frame: Baseline to post 6 weeks of resistance training + supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No. This is pilot data and therefore may not be powered for secondary analyses
Related trials for Perimenopause
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Not yet recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
Recruiting
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbie Smith-Ryan, PhD principal investigator
University of North Carollina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate in people with Perimenopause, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle quality (time frame: Baseline to after 6 weeks of resistance training and supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.