Protein and Exercise for Postmenopausal Women

(PROWELL Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Jamie Baum

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. It will also tell us about how higher protein intake changes body composition and blood values related to health. The main questions it aims to answer are: * Does higher protein intake combined with resistance training improve mood and sleep in postmenopausal women? * What other health benefits to postmenopausal women experience when the follow a higher protein diet and participate in resistance exercise? Researchers will compare three groups 1) postmenopausal women living their daily lives as usual, 2) postmenopausal women consuming a higher protein diet, and 2) postmenopausal women consuming a higher protein diet and participating in resistance training. Participants will: * Consume a higher protein diet for 16 weeks * Participate in an at-home resistance training for 16 weeks * Keep a diary of their food intake, sleep habits, and mood * Have health assessments every 4 weeks

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.

What data supports the effectiveness of the treatment involving diet, higher protein, physical activity, and resistance training for postmenopausal women?

Research shows that increasing protein intake and engaging in resistance training can improve functional capacity and physical performance in postmenopausal women, although the improvements in muscle strength and lean mass quality are modest. ^{1 2 3 4 5}

Is a higher protein diet and exercise safe for postmenopausal women?

Research shows that increasing protein intake and engaging in resistance training is generally safe for postmenopausal women. These studies did not report any significant safety concerns, suggesting that this combination can be part of a healthy lifestyle to support muscle and bone health. ^{1 2 3 6 7}

How does the treatment of higher protein diet and exercise differ for postmenopausal women?

This treatment is unique because it combines a higher protein diet with physical activity and resistance training, which together enhance muscle strength and bone health more effectively than either approach alone. Unlike other treatments, it focuses on lifestyle changes to prevent age-related muscle and bone deterioration, rather than relying solely on medication. ^{1 3 7 8 9}

Research Team

Jamie Baum

Principal Investigator

University of Arkansas System Division of Agriculture

Eligibility Criteria

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

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

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

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

Trial Timeline

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

Treatment Details

Interventions

• Diet - higher protein (Other)
• Physical activity and resistance training (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2021]

3. Switzerland 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Diet and menopausal health. [2008]

5. England pubmed.ncbi.nlm.nih.gov

The effect of protein diets in postmenopausal women with osteoporosis: Systematic review of randomized controlled trials. [2019]

6. Switzerland 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. [2018]

7. Ireland 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). [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Effects of soy protein and resistance exercise on body composition and blood lipids in postmenopausal women. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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