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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

MAAP Trial 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.

MAAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 60 minutes

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

MAAP 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,795 Total Patients Enrolled

1 Trials studying Perimenopause

172 Patients Enrolled for Perimenopause

American Diabetes AssociationOTHER

139 Previous Clinical Trials

99,576 Total Patients Enrolled

Abbie Smith-Ryan, PhDPrincipal InvestigatorUniversity of North Carolina

11 Previous Clinical Trials

459 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this trial restrict participation to those aged 70 or below?

"The guidelines for inclusion in this research project stipulate that participants must be aged 38 and above, with an upper age limit set at 60."

Answered by AI

Who qualifies to be an eligible participant for this trial?

"Individuals experiencing perimenopause between the ages of 38 and 60 are eligible to join this trial, with space for a maximum of 30 participants."

Answered by AI

Is there availability for participants in this research?

"Per information found on clinicaltrials.gov, the recruitment period for this experiment has been concluded; it was initially posted January 2nd 2024 and last updated October 18th 2023. Nevertheless, there remain 4 other investigations that are currently enrolling participants."

Answered by AI

What is the objective of this research endeavor?

"The primary evaluation of this clinical trial will be the alteration in glucose (mg/dL) between Baseline and 30 minutes post-exercise. Additionally, Metabolic flexibility assessed by Indirect calorimetry, Whole-body protein turnover gauged through L-alanine sampling over 24 hours, and Muscle quality obtained from MRI scans, pQCT imaging, and ultrasound evaluations shall also be monitored as secondary outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolic Effects of Perimenopause

2024. "Metabolic Effects of Perimenopause". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06098183.

All > Perimenopause > Menopause