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Pre-Exercise Protein for Perimenopause (MAAP Trial)

N/A
Recruiting
Led By Abbie Smith-Ryan, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Have a self-identified or clinically diagnosed eating disorder
Have uncontrolled hypertension or an abnormal electrocardiogram
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

This trial aims to understand how exercise and nutrition affect metabolism and muscle mass during and after menopause. It will test how HIIT and aerobic exercise combined with pre-exercise protein or carbs, impacts metabolic responses in overweight/obese women.

Who is the study for?
This trial is for early and late perimenopausal women aged 38 or older who are overweight (BMI: 28-40) with a body fat percentage of 30% or higher. They must be non-smokers, not currently pregnant or nursing, and have had changes in menstrual cycle regularity. Women with cardiovascular, metabolic disorders, recent weight fluctuations, or those on certain medications cannot participate.Check my eligibility
What is being tested?
The study tests how high intensity interval training (HIIT) versus traditional aerobic exercise affects metabolism in perimenopausal women when combined with pre-exercise consumption of either carbohydrates or protein. It aims to understand the impact on glucose levels, insulin sensitivity, energy expenditure, fat oxidation and muscle mass during this life stage.See study design
What are the potential side effects?
While specific side effects are not listed for consuming water or whey protein isolate before exercising; general potential side effects may include digestive discomfort such as bloating or gas from the whey protein especially if one is lactose intolerant.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with or believe I have an eating disorder.
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I have high blood pressure that isn't managed or an abnormal heart rhythm.
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I have gained or lost more than 5 kg in the last 2 months.
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I have been diagnosed with PCOS.
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I had a hysterectomy to manage menopause symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in energy expenditure (kcals/day) from baseline and 30 minutes post-exercise.
Change in energy expenditure (kcals/day) from baseline and up to 60 minutes post-exercise.
Change in respiratory exchange ratio (au) from baseline and 30 minutes post-exercise.
+1 more
Secondary outcome measures
Area under the curve for fat oxidation
Daily Record of Severity of Problems form
Metabolic flexibility
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Whey protein isolate, then Non-caloric placeboExperimental Treatment2 Interventions
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.
Group II: Non-caloric placebo, then Whey protein isolatePlacebo Group2 Interventions
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
High Intensity Interval Training (HIIT) and aerobic exercise, especially when combined with pre-exercise carbohydrate or protein ingestion, are effective treatments for managing perimenopausal symptoms due to their significant impact on metabolic health. HIIT improves insulin sensitivity and increases energy expenditure, which helps in reducing abdominal adiposity and maintaining muscle mass. Pre-exercise protein ingestion further enhances fat oxidation and protein turnover, supporting muscle preservation and metabolic flexibility. These mechanisms are crucial for perimenopausal patients as they help mitigate the accelerated loss of muscle mass and increase in body fat commonly experienced during this transition, thereby improving overall metabolic health and reducing the risk of insulin resistance and related conditions.
Resistive training increases insulin action in postmenopausal women.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,526 Previous Clinical Trials
4,197,207 Total Patients Enrolled
1 Trials studying Perimenopause
172 Patients Enrolled for Perimenopause
American Diabetes AssociationOTHER
141 Previous Clinical Trials
99,781 Total Patients Enrolled
Abbie Smith-Ryan, PhDPrincipal InvestigatorUniversity of North Carolina
12 Previous Clinical Trials
569 Total Patients Enrolled
~20 spots leftby Dec 2026