Actively Recruiting

Phase Not Applicable
FEMALE
ID06849817

PRO-WELL: Protein and Exercise for Postmenopausal Women's Wellbeing

Led by University of Arkansas, Fayetteville · Updated on 2025-02-27

90

Participants Needed

2

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying postmenopausal women to see if a higher protein diet including a daily serving of beef, combined with resistance exercise, can improve wellbeing. The study aims to find out if this combination improves mood and sleep and to explore other health benefits related to body composition and blood health measures. It compares three groups: women living normally, those on a higher protein diet, and those on that diet plus resistance training. Participants follow their usual diet or adopt a higher protein diet with beef consumption seven days a week, providing about 25 grams of protein per serving. One group also completes 150 minutes of physical activity weekly, including strength training sessions three times per week. These interventions are maintained for 16 weeks, with participants in the control group continuing their normal diet and activity patterns. During the study, participants keep diaries tracking their food intake, sleep, and mood. They undergo health assessments every four weeks, including measurements of sleep quality and duration, mood, quality of life, body composition, bone density, weight, and blood amino acid levels. The study monitors these outcomes over the 16-week period to assess changes related to diet and exercise interventions.

CONDITIONS

Brief Title

Protein and Exercise for Postmenopausal Women's Wellbeing

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women aged 50 years and older (at least 12 months since last menstrual cycle)
  • Engage in physical activity 2 to 4 times per week (e.g., brisk walking, yoga, hiking, cycling, gardening)
  • Participants on hormone replacement therapy for at least 6 months are allowed
  • Participants taking statins or antihypertensive medications are allowed
Not Eligible

You will not qualify if you...

  • Food allergies
  • Dietary restrictions such as vegan, vegetarian, or lactose intolerance
  • Conditions preventing higher protein intake, including impaired liver function or kidney disease
  • Consuming more than 0.8 g protein/kg body weight per day
  • Underweight with BMI less than 18.5
  • Taking nutritional supplements
  • Currently smoking or vaping
  • Use of marijuana
  • Drinking more than 4 alcoholic beverages per week
  • Taking medications that may interfere with sleep or mood outcomes, such as antidepressants or sleep medications
  • Sleep apnea or poor sleep quality (PSQI score greater than 5 or sleep over 7 hours per night)
  • Pre-existing health conditions like diabetes (type I or II), cancer, Parkinson's Disease, or Multiple Sclerosis
  • Conditions preventing full participation in the study activities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 16 weeks

Participants follow assigned interventions including a higher protein diet with beef consumption and/or physical activity with resistance training to assess effects on wellbeing.

Regular visits during the 16-week intervention

Trial Site Locations

Total: 2 locations

1

Don tyson Center for Agricultural Sciencers

Fayetteville, Arkansas, United States, 72704

Actively Recruiting

2

University of Arkansas

Fayetteville, Arkansas, United States, 72704

Actively Recruiting

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Research Team

J

Jamie Baum, PhD

S

Samuel Attu, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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