Pre-Exercise Protein for Perimenopause

(MAAP Trial)

Overseen By Abbie Smith-Ryan, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

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

Disqualifiers: Cardiovascular disease, Diabetes, Hypertension, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different types of exercise affect metabolism in perimenopausal women. It will compare high-intensity interval training (HIIT) to traditional aerobic exercise, with participants consuming either a whey protein drink (Whey Protein Isolate) or a non-caloric placebo before exercise. Researchers seek to determine how these combinations influence factors like insulin sensitivity, energy use, and fat burning. Women in early or late perimenopause, who are overweight or obese, and do not smoke might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance exercise recommendations for perimenopausal 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that whey protein isolate can cause some side effects. It might lead to stomach upset, allergic reactions, or hormonal effects. Some studies suggest it could strain the kidneys and be linked to liver problems. Despite these concerns, whey protein isolate remains a high-quality protein that is easy to digest and absorb. Many people use it without issues, but those with specific allergies or health conditions should exercise caution. Consulting a doctor is advisable for anyone with concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of whey protein isolate for perimenopause because it offers a novel approach to managing the symptoms associated with this transition. Unlike traditional treatments that often involve hormone therapy, whey protein isolate is a natural supplement that may support muscle health and energy levels when consumed before exercise. This approach could provide a non-hormonal option for enhancing physical performance and overall well-being in perimenopausal women, making it a potentially valuable addition to existing management strategies. Additionally, its use as a pre-exercise supplement is easy to incorporate into daily routines, which might encourage better adherence and effectiveness.

What evidence suggests that this trial's treatments could be effective for perimenopause?

Research has shown that whey protein can aid body composition by potentially reducing body fat and supporting muscle health. One study found that individuals who consumed whey protein lost more fat, even without strength exercises, suggesting whey protein might help maintain muscle during exercise. Another study indicated that whey protein could improve the body's protein utilization, crucial for muscle health. While some research shows mixed results, many studies suggest whey protein benefits body composition and metabolism. In this trial, participants will receive either whey protein isolate or a non-caloric placebo before exercise. These findings offer hope that whey protein could assist women in perimenopause in managing body changes. ^{6 7 8 9 10}

Who Is on the Research Team?

Abbie Smith-Ryan, PhD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

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

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

I have been diagnosed with or believe I have an eating disorder.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Non-caloric Placebo water
• Whey Protein Isolate

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.

How Is the Trial Designed?

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+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

Milk basic protein (MBP) has been shown to increase bone mineral density (BMD) in both healthy young adult women and perimenopausal women, promoting bone formation and inhibiting bone resorption.

In perimenopausal women, MBP primarily increased BMD by inhibiting bone resorption while maintaining bone formation, suggesting it could be a beneficial supplement for bone health across different age groups, especially for those who dislike milk.

NCBI (Pubmed)

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]. Itabashi, A.[2015]

In a study involving 20 overweight and obese post-menopausal women, consuming 45 g of whey protein isolate significantly reduced triglyceride levels in the blood by 21% compared to a glucose control and by 27% compared to sodium caseinate.

Whey protein also led to a lower blood glucose response compared to the glucose meal, suggesting that it may help manage lipid levels and glucose metabolism in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Whey protein supplementation combined with resistance training significantly improves biceps curl strength and lower limb lean mass in postmenopausal women, based on a meta-analysis of 10 studies.

Without resistance training, whey protein does not provide significant benefits for muscle strength or lean mass, and it may even negatively impact dietary protein intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Whey Protein Supplementation in Postmenopausal Women: A Systematic Review and Meta-Analysis. Kuo, YY., Chang, HY., Huang, YC., et al.[2022]

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]

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 24-week double-blind study involving 69 perimenopausal women, neither isoflavone-rich nor isoflavone-poor soy protein showed any significant effect on reducing hot flushes or night sweats compared to a whey protein control.

All treatment groups experienced a decline in menopausal symptoms over time, suggesting that the observed improvements may be due to a placebo effect or natural symptom relief rather than the specific treatments administered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isoflavone-rich or isoflavone-poor soy protein does not reduce menopausal symptoms during 24 weeks of treatment. St Germain, A., Peterson, CT., Robinson, JG., et al.[2019]

A study involving 78 perimenopausal women showed that a combined intervention of intensive education, individualized dietary guidance, and resistance exercise led to significant improvements in physical health, including reduced body fat and waist circumference, and increased muscle mass after three months.

Group C, which received the most comprehensive intervention, had the highest dietary scores and showed the most significant benefits in exercise habits and body composition, highlighting the effectiveness of combining multiple health strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary and Exercise Interventions for Perimenopausal Women: A Health Status Impact Study. Hao, S., Tan, S., Li, J., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9572824/

Effect of Whey Protein Supplementation in ... In the subgroup of participants without RT, the results revealed that WP supplementation showed an increase in FM loss (SMD: −1.2825, 95% CI: − ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622106589

Whey Protein Supplementation and Higher Total ... Alhough WP supplementation and increased TPro during exercise training may elicit beneficial effects on body composition, particularly soft tissue, it appears ...

3. researchgate.net researchgate.net/publication/26236800_Effects_of_Whey_and_Fortified_Collagen_Hydrolysate_Protein_Supplements_on_Nitrogen_Balance_and_Body_Composition_in_Older_Women

Effects of Whey and Fortified Collagen Hydrolysate Protein ... The results showed that nitrogen balance and body weight in the hydrolyzed collagen-treated group were better than those of whey protein-treated ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6769754/

Comparative Meta-Analysis of the Effect of Concentrated ... Our results show that, in this situation, there is no positive effect for FFM gain regardless of type of WP used, its protein percentage, or ...

5. researchgate.net researchgate.net/publication/236044647_Effect_of_Soy_Isolate_Protein_and_Resistance_Exercises_on_Muscle_Performance_and_Bone_Health_of_OsteopenicOsteoporotic_Post-Menopausal_Women

Effect of Soy Isolate Protein and Resistance Exercises on ... The main objective of this study was to assess the influence of soy isolate protein intake and resistance exercises on isokinetic muscle ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10815430/

Investigating the Health Implications of Whey Protein ... The review reveals significant findings, such as WP's potential link to liver and kidney damage, alterations in gut microbiota, increased acne incidence, ...

7. dymatize.com dymatize.com/iso100

ISO100® Hydrolyzed Protein Powder One of the highest-quality protein powders in the game, it's filtered to remove excess lactose, carbs, fat, and sugar for maximum mixability and gains.

8. gnc.com gnc.com/whey-protein/DymatizeNutritionISO100.html?srsltid=AfmBOoplXbCxPyLmUmifPCC6oY8zmFC7p2E9nZHsZ28GwsXjfnozCsEa

Dymatize ISO 100 Whey Protein Isolate Powder Dymatize ISO 100 provides 25 g of super fast-absorbing whey protein isolate plus amino acid replenishment to help support your intense training.

9. amazon.com amazon.com/Dymatize-ISO100-Hydrolyzed-Protein-Isolate/dp/B0CW2VB3WY

Dymatize ISO100 Hydrolyzed Protein Powder, 100% ... Each easy-mixing, fast-absorbing, easy-digesting serving has 25 grams of high-quality protein from 100% whey protein isolate.

10. ultimatesupsg.com ultimatesupsg.com/blogs/nutrition/dymatize-iso-100-side-effects?srsltid=AfmBOoqTAGWoo8zglVP8OtioasXditcq6BSGDPft0sFQcYZ5M6N-_oi4

Dymatize ISO 100 Side Effects: What to Watch For (2025) Despite its benefits, potential side effects like digestive discomfort, allergic reactions, hormonal imbalance, and kidney strain may occur.