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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
Summary
This trial aims to compare the effects of high-intensity interval training (HIIT) and traditional aerobic exercise on metabolism in overweight or obese women going through perimenopause. The study will also look at how eating protein or carbohydrates before exercise affects these outcomes. The goal is to understand how these exercises and dietary choices can help manage weight and improve metabolic health during perimenopause. High-intensity interval training (HIIT) has been shown to significantly decrease body weight and fat mass, with more pronounced effects in premenopausal 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.
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.
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:Select...
I have been diagnosed with or believe I have an eating disorder.
Select...
I have high blood pressure that isn't managed or an abnormal heart rhythm.
Select...
I have gained or lost more than 5 kg in the last 2 months.
Select...
I have been diagnosed with PCOS.
Select...
I had a hysterectomy to manage menopause symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 60 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Area under the curve for fat oxidation
Daily Record of Severity of Problems form
Metabolic flexibility
+1 moreTrial 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.
Resistive training increases insulin action in postmenopausal women.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,568 Previous Clinical Trials
4,302,054 Total Patients Enrolled
1 Trials studying Perimenopause
172 Patients Enrolled for Perimenopause
American Diabetes AssociationOTHER
146 Previous Clinical Trials
101,649 Total Patients Enrolled
Abbie Smith-Ryan, PhDPrincipal InvestigatorUniversity of North Carolina
12 Previous Clinical Trials
569 Total Patients Enrolled