Pre-Exercise Protein for Perimenopause

(MAAP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Abbie Smith-Ryan, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Corticosteroids, Stimulants, Insulin, others

Disqualifiers: Cardiovascular disease, Diabetes, Hypertension, others

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking metabolism-altering drugs or medications, except for estrogen replacement therapy, as they may influence study outcomes.

What data supports the effectiveness of the treatment Non-caloric Placebo water, Whey Protein Isolate, Whey Protein Isolate, WPI for perimenopausal women?

Research shows that milk whey protein, particularly its basic protein fraction, can improve bone health by increasing bone mineral density in perimenopausal women. This suggests that whey protein isolate, a component of the treatment, may help maintain or improve bone health in this population. ^{1 2 3 4 5}

How does pre-exercise protein differ from other treatments for perimenopause?

Pre-exercise protein, particularly milk basic protein (MBP), is unique because it helps increase bone mineral density by promoting bone formation and inhibiting bone resorption, which is beneficial for bone health in perimenopausal women. This approach is different from other treatments as it focuses on maintaining bone health through dietary supplementation rather than medication. ^{1 2 6 7 8}

Research Team

Abbie Smith-Ryan, PhD

Principal Investigator

University of North Carolina

Eligibility Criteria

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.

Inclusion Criteria

Your body mass index (BMI) falls within the range of 28 - 40 Kg/m^2 and your percent body fat (%BF) is equal to or greater than 30%.

You are a non-smoker and in good physical health.

I am a woman over 38 experiencing changes in my menstrual cycle.

Exclusion Criteria

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

I have no major health issues or surgeries in the last 6 months that could affect my safety in the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in high intensity interval training (HIIT) and traditional aerobic exercise, with pre-exercise carbohydrate or protein ingestion

8-12 weeks

Multiple visits for exercise sessions and assessments

Follow-up

Participants are monitored for metabolic responses, including energy expenditure and respiratory exchange ratio, after exercise

4 weeks

Treatment Details

Interventions

• Non-caloric Placebo water (Other)
• Whey Protein Isolate (Other)

Trial Overview 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.

Participant Groups

Group I: Whey protein isolate, then Non-caloric placebo Experimental Treatment 2 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 isolate Placebo Group 2 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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Charles D. Henderson

American Diabetes Association

Chief Executive Officer since 2020

Bachelor's degree from Texas A&M University

Osagie Ebekozien

American Diabetes Association

Chief Medical Officer since 2024

MD, MPH, CPHQ

Findings from Research

In a study of 124 healthy perimenopausal women, a dietary supplement containing soy isoflavones and Actaea racemosa was tested for its effects on climacteric symptoms over 12 weeks.

While both the supplement and placebo groups showed improvements in symptoms, there was no statistically significant difference between the two groups, indicating the supplement did not effectively alleviate climacteric symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a combination of isoflavones and Actaea racemosa Linnaeus on climacteric symptoms in healthy symptomatic perimenopausal women: a 12-week randomized, placebo-controlled, double-blind study. Verhoeven, MO., van der Mooren, MJ., van de Weijer, PH., et al.[2021]

In a study involving 12 healthy postmenopausal women, low-intensity, high-volume resistance training significantly improved muscle strength and thickness, particularly in exercises like biceps curls and leg extensions.

However, supplementing with whey protein during training did not provide any additional benefits compared to a placebo, indicating that the training itself was the key factor in enhancing muscle outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey protein and high-volume resistance training in postmenopausal women. Weisgarber, KD., Candow, DG., Farthing, JP.[2018]

Whey protein intake significantly reduces energy intake and appetite in healthy young men more than in women, with men experiencing an average decrease of 206 kcal compared to 46 kcal in women after consuming whey protein.

The study found that the effects of whey protein on gastric emptying and gut hormone responses also differ by gender, indicating that men and women may respond differently to protein supplements in terms of appetite regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of gender on the acute effects of whey protein ingestion on energy intake, appetite, gastric emptying and gut hormone responses in healthy young adults. Giezenaar, C., Luscombe-Marsh, ND., Hutchison, AT., et al.[2020]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Prevention of osteoporosis by foods and dietary supplements. Milk basic protein (MBP) increases bone mineral density in young adult women and perimenopausal women]. [2015]

2. Ireland pubmed.ncbi.nlm.nih.gov

Acute effects of whey protein isolate on cardiovascular risk factors in overweight, post-menopausal women. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Isoflavone-rich or isoflavone-poor soy protein does not reduce menopausal symptoms during 24 weeks of treatment. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a combination of isoflavones and Actaea racemosa Linnaeus on climacteric symptoms in healthy symptomatic perimenopausal women: a 12-week randomized, placebo-controlled, double-blind study. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary and Exercise Interventions for Perimenopausal Women: A Health Status Impact Study. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Whey protein and high-volume resistance training in postmenopausal women. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Whey Protein Supplementation in Postmenopausal Women: A Systematic Review and Meta-Analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effect of gender on the acute effects of whey protein ingestion on energy intake, appetite, gastric emptying and gut hormone responses in healthy young adults. [2020]