Protein and Exercise for Postmenopausal Women

(PROWELL Trial)

Recruiting at 1 trial location

Overseen By Samuel Attu, MS

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas, Fayetteville

Must not be taking: Antidepressants, Sleep medication

Disqualifiers: Food allergies, Dietary restrictions, Kidney disease, Underweight, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether increased protein intake, including a daily serving of beef, combined with resistance exercise, can improve wellbeing in postmenopausal women. Researchers aim to determine if this combination benefits mood, sleep, and overall health. Participants will be divided into three groups for comparison: one group will maintain their normal routines, another will follow a high-protein diet, and the last will combine the diet with resistance training. Women who have been postmenopausal for at least a year and engage in some physical activity may be suitable for this trial.

As an unphased study, this trial provides a unique opportunity to contribute to understanding how lifestyle changes can enhance postmenopausal health.

Will I have to stop taking my current medications?

The trial allows participants to continue taking hormone replacement therapy, statins, and antihypertensive medications. However, if you are taking antidepressants, sleep medications, or other medications that might interfere with the study's outcomes, you may need to stop those.

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

Research has shown that a high-protein diet, including beef, is generally safe for postmenopausal women. Studies have found no harmful effects on bone health or increased risk of death from consuming animal protein. In one study, postmenopausal women consumed a similar amount of protein for seven weeks without harming their bones.

Adding physical activity, such as resistance training, is also safe. Resistance training improves body shape and strength in postmenopausal women and prevents muscle loss. Other research supports that combining increased protein intake with exercise is generally safe, with no major side effects reported. Overall, both approaches have been well-tolerated in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of higher protein intake and physical activity for postmenopausal women because it offers a holistic approach to improving health outcomes. Unlike current dietary guidelines that often focus on moderate protein intake, this treatment explores the benefits of a higher protein diet, specifically with beef, to potentially enhance muscle mass and strength. Adding physical activity, including resistance training, aims to further boost these benefits, providing a dual approach that could outperform existing strategies focused solely on diet or exercise. This integration could lead to better management of age-related muscle loss and overall well-being in postmenopausal women.

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

This trial will evaluate the effects of a higher protein diet and physical activity on postmenopausal women. Research has shown that increased protein intake can help postmenopausal women build muscle and gain strength. Participants in one arm of this trial will consume beef as part of a higher protein diet. Another arm will combine this diet with physical activity, including strength training. Studies have found that women who consume more protein often have less body fat and stronger muscles. Adding exercises like weightlifting to a high-protein diet can be even more beneficial, promoting muscle gain and fat loss. Weightlifting also increases strength and helps prevent age-related muscle loss. Overall, these methods can lead to better physical health after menopause. ^{3 6 7 8 9}

Who Is on the Research Team?

Jamie Baum

Principal Investigator

University of Arkansas System Division of Agriculture

Are You a Good Fit for This Trial?

This trial is for postmenopausal women interested in exploring how a higher protein diet with beef and resistance exercise affects their wellbeing. Participants will follow the diet and exercise plan for 16 weeks, keep a diary, and undergo health assessments every 4 weeks.

Inclusion Criteria

Participant in physical activity (e.g., 2-4 bouts of physical activity per week such as brisk walking, yoga, hiking, cycling, gardening, etc.)

I am a woman over 50 and have not had a period in the last year.

I am on HRT, statins, or blood pressure medicine for at least 6 months.

Exclusion Criteria

Participants consuming more than 0.8 g protein/kg/body weight per day (determined by 24-hour dietary recall)

Dietary restrictions (e.g., vegan, vegetarian, lactose intolerance, etc.)

I can't eat a high-protein diet due to a health condition like liver or kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume a higher protein diet and participate in resistance training for 16 weeks

16 weeks

Health assessments every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diet - higher protein
• Physical activity and resistance training

Trial Overview

The study tests if mood and sleep improve when postmenopausal women eat more protein alongside resistance training. It compares three groups: those who don't change their habits, those who only eat more protein, and those who combine the diet with exercise.

How Is the Trial Designed?

Group I: Protein (Beef) + Physical Activity Experimental Treatment 2 Interventions

Participants will be asked to consume beef 7 times per week (1 serving per day; 25 grams protein per serving (\~100 grams beef to yield 25 grams of protein)) as part of a higher protein diet (1.6 g protein/kg body weight) in combination with 150 minutes of physical activity including strength training 3 times per week.

Group II: Protein (Beef) Experimental Treatment 1 Intervention

Participants will asked to consume beef 7 times per week (1 serving per day; 25 grams protein per serving (\~100 grams beef) as part of a higher protein diet (1.6 g protein/kg body weight).

Group III: Control Active Control 1 Intervention

Participants are free-living and are asked to follow their typical dietary pattern and physical activity pattern. Maintain protein consumption at 0.8 g protein /kg body weight or less and limit red meat consumption for 16 weeks.

Who Is Running the Clinical Trial?

University of Arkansas, Fayetteville

Lead Sponsor

Trials

24

Recruited

2,100+

Published Research Related to This Trial

Regular exercise and a healthy diet can significantly reduce the risk of major diseases in women during and after menopause, including cardiovascular diseases, cancer, and osteoporosis.

The article reviews various studies that highlight the importance of lifestyle changes in managing health risks associated with menopause, emphasizing the need for women to adopt proactive health measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and menopausal health. Cassidy, A.[2008]

Protein supplementation, particularly from animal sources and whey protein, can positively impact osteoporosis in postmenopausal women, as shown in a systematic review of 5 randomized controlled trials involving 677 participants aged 50 to 80 years.

Both combined protein intake through diet and supplements, as well as single protein supplement administration, may reduce fracture risk in these women, while dietary proteins alone at recommended levels do not show beneficial effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of protein diets in postmenopausal women with osteoporosis: Systematic review of randomized controlled trials. Koutsofta, I., Mamais, I., Chrysostomou, S.[2019]

In a study of 46 postmenopausal women, those who engaged in resistance training (both with and without soy protein) gained muscle mass and reduced waist circumference, highlighting the effectiveness of exercise in improving body composition.

Soy protein supplementation alone led to significant reductions in total cholesterol and LDL levels, suggesting it may have beneficial effects on lipid profiles in postmenopausal women, even though it did not impact body composition directly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of soy protein and resistance exercise on body composition and blood lipids in postmenopausal women. Maesta, N., Nahas, EA., Nahas-Neto, J., et al.[2013]

Increasing protein intake to twice the recommended daily allowance (1.6 g/kg body weight) did not lead to significant improvements in lean body mass or muscle strength in 26 postmenopausal women aged 65 and older over a 6-month period.

Both groups experienced similar reductions in total body fat and trunk fat mass, but there were no significant differences in physical performance measures like handgrip strength and gait speed between the higher and standard protein intake groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high protein, low-glycemic index diet on lean body mass, strength, and physical performance in late postmenopausal women: a randomized controlled trial. Silva, TR., Lago, SC., Yavorivski, A., 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 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]

Postmenopausal women over 50 are at higher risk for sarcopenia and osteoporosis, but these risks can be reduced through healthy lifestyle changes, including adequate protein, calcium, and vitamin D intake, along with regular exercise.

The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommends a daily protein intake of 1.0-1.2g/kg body weight, 800 IU of vitamin D, and 1000 mg of calcium, combined with exercise 3-5 times a week, to help maintain musculoskeletal health and prevent age-related deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of dietary protein and vitamin D in maintaining musculoskeletal health in postmenopausal women: a consensus statement from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Rizzoli, R., Stevenson, JC., Bauer, JM., et al.[2022]

In a study of 23 postmenopausal women over 10 weeks, both higher protein intake (1.2 g·kg-1·day-1) and the Recommended Dietary Allowance (0.8 g·kg-1·day-1) resulted in similar gains in lean body mass (LBM) after resistance training.

Despite the higher protein group consuming more protein and leucine, there was no significant difference in LBM gain compared to the normal protein group, suggesting that the RDA may be sufficient for muscle growth in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher Protein Intake Does Not Improve Lean Mass Gain When Compared with RDA Recommendation in Postmenopausal Women Following Resistance Exercise Protocol: A Randomized Clinical Trial. Rossato, LT., Nahas, PC., de Branco, FMS., et al.[2018]

A moderate increase in protein intake (to ~1.2 g/kg/d) in postmenopausal women led to small additional improvements in functional capacity after 10 weeks of resistance training, particularly in walking speed tests.

However, both normal protein intake (0.8 g/kg/d) and higher protein intake groups showed similar increases in muscle strength and lean mass quality, indicating that the higher protein intake did not significantly enhance strength or lean mass improvements compared to the normal intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate Increase in Protein Intake Promotes a Small Additional Improvement in Functional Capacity, But Not in Muscle Strength and Lean Mass Quality, in Postmenopausal Women Following Resistance Exercise: A Randomized Clinical Trial. Nahas, PC., Rossato, LT., Martins, FM., et al.[2020]

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