What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for perimenopause, such as High Intensity Interval Training (HIIT) and aerobic exercise combined with pre-exercise carbohydrate or protein ingestion, generally have positive effects on metabolic health, including improved insulin sensitivity, increased energy expenditure, enhanced fat oxidation, and better protein turnover. However, potential side effects may include muscle soreness, fatigue, and an increased risk of injury if not performed correctly. Additionally, individuals may experience gastrointestinal discomfort from pre-exercise carbohydrate or protein ingestion. It is important to tailor exercise intensity and nutritional intake to individual tolerance levels to minimize these side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for perimenopausal symptoms, primarily focusing on hormone replacement therapies (HRT) such as estrogen and progestin combinations. These treatments aim to alleviate symptoms like hot flashes and prevent bone loss. While there are no specific FDA approvals for treatments combining high-intensity interval training (HIIT) or aerobic exercise with pre-exercise carbohydrate or protein ingestion, these lifestyle interventions are recognized for their benefits in improving metabolic health, including enhanced insulin sensitivity, increased energy expenditure, and better fat oxidation and protein turnover. These non-pharmacological approaches are often recommended alongside medical treatments to manage perimenopausal symptoms and improve overall health.

What other types of research exist?

Promising novel alternatives for perimenopausal patients in 2024 include: 1) Resistance training, which can help maintain muscle mass and improve insulin sensitivity. 2) Mind-body exercises like yoga and tai chi, which can reduce stress and improve metabolic health. 3) Nutritional interventions such as intermittent fasting or time-restricted eating, which may enhance fat oxidation and energy expenditure. 4) Use of supplements like omega-3 fatty acids and vitamin D, which can support metabolic flexibility and overall health.

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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 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:

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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 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

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 more

Secondary study objectives

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.

0 / 5Eligibility criteria met

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.

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,543 Previous Clinical Trials

4,249,012 Total Patients Enrolled

1 Trials studying Perimenopause

172 Patients Enrolled for Perimenopause

American Diabetes AssociationOTHER

141 Previous Clinical Trials

99,598 Total Patients Enrolled

Abbie Smith-Ryan, PhDPrincipal InvestigatorUniversity of North Carolina

12 Previous Clinical Trials

569 Total Patients Enrolled

~20 spots leftby Dec 2026

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