Perimenopausal DisorderMAAPNCT06098183
Metabolic Effects of Perimenopause
A study testing Whey Protein Isolate in people with Perimenopausal Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 38 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Disorder
- What is being tested?
- Whey Protein Isolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 8 Aug 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Early and late perimenopausal women (≥38 years; early: experienced menstrual bleeding in the previous 3 months with a decrease in cycle regularity in the past year; late: no menstrual bleeding in the previous 3 months with some bleeding in the previous year).
- Overweight and obese: body mass index (BMI) of 28 - 40 Kg/m^2 and percent body fat (%BF) ≥ 30%.
- Healthy, non-smokers.
Who cannot join
- Have current and/or history of cardiovascular disease, diabetes, metabolic, thyroid, pulmonary, renal, hepatic, gastrointestinal, musculoskeletal disorders or medical or surgical events, such as bariatric surgery, heart surgery, or any joint or musculoskeletal injuries or surgeries occurring in the 6-months prior to enrollment, that may significantly influence study outcomes or prevent safe participation.
- Gained or lost >5 kg in the previous 2 months
- Have a self-identified or clinically diagnosed eating disorder
- Undergone a full or partial hysterectomy for treatment of menopausal symptoms
- Have uncontrolled hypertension or an abnormal electrocardiogram.
- Have an ongoing diagnosed mental disorder with a change in medication in the previous 6 months.
Show all 14Show fewer
- Taking metabolism-altering drugs or medications outside of estrogen replacement therapy that may influence study outcomes (i.e. corticosteroids, stimulants, insulin, thyroid medications) or phytoestrogens.
- Diagnosed with polycystic ovarian syndrome (PCOS).
- Participating in more than 75 minutes per week of moderate exercise per week.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Physiology Laboratory - University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Metabolic Effects of Muscle and Exercise Across Perimenopause
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.
- Conditions
- Perimenopausal Disorder
- Being tested
- Whey Protein Isolate, Non-caloric Placebo water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein IsolateOther
Also called Dymatize Iso 100
Whey protein isolate essential amino acids (25 g), 5.5 grams of branched-chain amino acids (BCAAs), and 2.7 grams of Leucine per serving
Non-caloric Placebo waterOther
Also called Water, placebo
Non-caloric placebo
| Study group | Role | What they receive |
|---|---|---|
| Whey protein isolate, then Non-caloric placebo | Experimental | Participants will randomly consume a whey protein isolate (Dymatize ISO-100) mixed with 6 oz of water prior to exercise. After a minimum of 48 hrs they will consume a non-caloric placebo (6 oz of water) prior to exercise. Receives: Other: Whey Protein Isolate; Other: Non-caloric Placebo water |
| Non-caloric placebo, then Whey protein isolate | Placebo comparator | Participants will randomly consume a non-caloric placebo (6 oz of water) prior to exercise. After a minimum of 48 hrs they will consume a whey protein isolate (Dymatize ISO-100) mixed with 6 oz of water prior to exercise. Receives: Other: Whey Protein Isolate; Other: Non-caloric Placebo water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy expenditure (kcals/day) from baseline and 30 minutes post-exercise.
Indirect calorimetry will be used to obtain energy expenditure prior to exercise and 30 minutes after a bout of high intensity interval training.
Measured: Baseline and 30 minutes
Change in energy expenditure (kcals/day) from baseline and up to 60 minutes post-exercise.
Indirect calorimetry will be used to obtain energy expenditure prior to exercise and 60 minutes after a bout of high intensity interval training.
Measured: Baseline and 60 minutes
Change in respiratory exchange ratio (au) from baseline and 30 minutes post-exercise.
Indirect calorimetry will be used to obtain respiratory exchange ratio prior to exercise 30 minutes after a bout of high intensity interval training.
Measured: Baseline and 30 minutes
Change in respiratory exchange ratio (au) from baseline and up to 60 minutes post-exercise.
Indirect calorimetry will be used to obtain respiratory exchange ratio prior to exercise and 60 minutes after a bout of high intensity interval training.
Measured: Baseline and 60 minutes
Secondary outcomes (4)
Area under the curve for fat oxidation
Microdialysis of subcutaneous adipose tissue ll be used to obtain fat oxidation prior to exercise and through 60 minutes after a bout of high intensity interval training.
Measured: Baseline through 60 minutes
Metabolic flexibility
Indirect calorimetry during a ramp exercise protocol
Measured: Baseline
Muscle quality
Muscle quality measured from magnetic resonance imaging (MRI), peripheral quantitative computed tomography (pQCT), and ultrasound will be evaluated.
Measured: Baseline
Daily Record of Severity of Problems form
Menstrual Related Mood Disorders Daily Rating Form (MRMD) will be measured on a 6 point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = severe and 6 = extreme), Scores range from 1-6, with higher values indicating worse symptoms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start22 Mar 2024
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover design
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098183
- Sponsor's protocol ID
- 23-2338
- Acronym
- MAAP
- Status last verified
- Sep 2025
- First submitted
- 18 Oct 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Muscle and Exercise Across Perimenopause
- ClinicalTrials.gov ID
- NCT06098183
- Acronym / sponsor ID
- MAAP / 23-2338
- Conditions
- Perimenopausal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 24 Oct 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Whey protein isolate, then Non-caloric placebo | Experimental | Other: Whey Protein Isolate, Other: Non-caloric Placebo waterParticipants will randomly consume a whey protein isolate (Dymatize ISO-100) mixed with 6 oz of water prior to exercise. After a minimum of 48 hrs they will consume a non-caloric placebo (6 oz of water) prior to exercise. |
| Non-caloric placebo, then Whey protein isolate | Placebo comparator | Other: Whey Protein Isolate, Other: Non-caloric Placebo waterParticipants will randomly consume a non-caloric placebo (6 oz of water) prior to exercise. After a minimum of 48 hrs they will consume a whey protein isolate (Dymatize ISO-100) mixed with 6 oz of water prior to exercise. |
Who may qualify
- Ages
- 38 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Early and late perimenopausal women (≥38 years; early: experienced menstrual bleeding in the previous 3 months with a decrease in cycle regularity in the past year; late: no menstrual bleeding in the previous 3 months with some bleeding in the previous year).
- Overweight and obese: body mass index (BMI) of 28 - 40 Kg/m^2 and percent body fat (%BF) ≥ 30%.
- Healthy, non-smokers.
Key exclusion criteria (14 listed)
- Have current and/or history of cardiovascular disease, diabetes, metabolic, thyroid, pulmonary, renal, hepatic, gastrointestinal, musculoskeletal disorders or medical or surgical events, such as bariatric surgery, heart surgery, or any joint or musculoskeletal injuries or surgeries occurring in the 6-months prior to enrollment, that may significantly influence study outcomes or prevent safe participation.
- Gained or lost >5 kg in the previous 2 months
- Have a self-identified or clinically diagnosed eating disorder
- Undergone a full or partial hysterectomy for treatment of menopausal symptoms
- Have uncontrolled hypertension or an abnormal electrocardiogram.
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 |
|---|---|---|
| Whey Protein IsolateAlso: Dymatize Iso 100Whey protein isolate essential amino acids (25 g), 5.5 grams of branched-chain amino acids (BCAAs), and 2.7 grams of Leucine per serving | Other | Non-caloric placebo, then Whey protein isolate, Whey protein isolate, then Non-caloric placebo |
| Non-caloric Placebo waterAlso: Water, placeboNon-caloric placebo | Other | Non-caloric placebo, then Whey protein isolate, Whey protein isolate, then Non-caloric placebo |
Primary outcome
Change in energy expenditure (kcals/day) from baseline and 30 minutes post-exercise.
Time frame: Baseline and 30 minutes
Indirect calorimetry will be used to obtain energy expenditure prior to exercise and 30 minutes after a bout of high intensity interval training.
Change in energy expenditure (kcals/day) from baseline and up to 60 minutes post-exercise.
Time frame: Baseline and 60 minutes
Indirect calorimetry will be used to obtain energy expenditure prior to exercise and 60 minutes after a bout of high intensity interval training.
Change in respiratory exchange ratio (au) from baseline and 30 minutes post-exercise.
Time frame: Baseline and 30 minutes
Indirect calorimetry will be used to obtain respiratory exchange ratio prior to exercise 30 minutes after a bout of high intensity interval training.
Change in respiratory exchange ratio (au) from baseline and up to 60 minutes post-exercise.
Time frame: Baseline and 60 minutes
Indirect calorimetry will be used to obtain respiratory exchange ratio prior to exercise and 60 minutes after a bout of high intensity interval training.
4 secondary outcomes
Area under the curve for fat oxidation
Time frame: Baseline through 60 minutes
Metabolic flexibility
Time frame: Baseline
Muscle quality
Time frame: Baseline
Daily Record of Severity of Problems form
Time frame: Baseline
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 Sep 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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 Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Isolate in people with Perimenopausal Disorder, 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 3 inclusion and 14 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 Sep 2025. 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?
Change in energy expenditure (kcals/day) from baseline and 30 minutes post-exercise. (time frame: Baseline and 30 minutes). The study lists 4 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 Sep 2025.