Higher protein diet and exercise for postmenopausal women's wellbeing
PRO-WELL: Protein and Exercise for Postmenopausal Women's Wellbeing
This study is testing if a higher protein diet with daily beef and resistance exercise can improve mood, sleep, and overall health in postmenopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Sex | Female |
| Sponsor | University of Arkansas, Fayetteville Academic / other |
| Locations | 2 sites (Fayetteville, Arkansas and 1 other locations) |
| Trial ID | NCT06849817 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if a higher protein diet, including one serving of beef daily, combined with resistance exercise, can enhance wellbeing in postmenopausal women. Participants will be divided into three groups: those maintaining their usual lifestyle, those following a higher protein diet, and those on a higher protein diet with resistance training. The study will assess improvements in mood, sleep, body composition, and health-related blood values over a 16-week period. The goal is to identify the health benefits associated with dietary and exercise interventions in this population.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 50 and older who engage in regular physical activity.
Not a fit: Patients with dietary restrictions, food allergies, or certain health conditions that prevent higher protein intake may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mood and sleep quality for postmenopausal women through dietary and exercise modifications.
How similar studies have performed: Other studies have shown positive outcomes with dietary and exercise interventions in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal women aged 50 years and older (at least 12 months since last menstrual cycle) * Participant in physical activity (e.g., 2-4 bouts of physical activity per week (i.e., activities such as brisk walking, yoga, hiking, cycling, gardening, etc.)) -Participants taking hormone replacement therapy (HRT; at least 6 months on HRT), statins, and antihypertensive medications will be allowed to participate. Exclusion Criteria: * Food allergies * Dietary restrictions (e.g., vegan, vegetarian, lactose intolerance, etc.) * Diet-related conditions that would prevent them from consuming a higher protein dietary intake (e.g., impaired liver function, kidney disease) * Participants consuming more than 0.8 g protein/kg/body weight per day (determined by 24-hour dietary recall) * Underweight (BMI \< 18.5) * Taking nutritional supplements * Currently smoking or vaping * Use marijuana * Drink more than 4 alcoholic beverages a week * Take medications that may interfere with the primary outcomes of the dietary intervention (e.g., antidepressants, sleep medication, etc.) * Sleep apnea * Pittsburgh Sleep Quality Index (PSQI) global score \>5 via or sleep \> 7 hours a night * Pre-existing health conditions (e.g., diabetes (type I or II), cancer, Parkinson's Disease, Multiple Sclerosis) or conditions that would prevent them from fully participating in all aspects of the study.
Where this trial is running
Fayetteville, Arkansas and 1 other locations
- Don tyson Center for Agricultural Sciencers — Fayetteville, Arkansas, United States (Recruiting)
- University of Arkansas — Fayetteville, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Jamie Baum — University of Arkansas System Division of Agriculture
- Study coordinator: Jamie Baum, PhD
- Email: baum@uark.edu
- Phone: 479-575-4474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.