Protein and Exercise for Postmenopausal Women's Wellbeing

Official title

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

Overview

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

Interventions

• Other Diet - higher protein
  Beef consumption 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)
• Behavioral Physical activity and resistance training
  150 minutes of physical activity including strength training 3 times per week

Primary outcome measures

• Sleep Quality and Duration [Time frame: 16 weeks]
• Mood [Time frame: 16 weeks]
• Qualify of Life Assessment [Time frame: 16 weeks]

Secondary outcome measures (7)

• Height [Time frame: 16 weeks]
• Dietary intake [Time frame: 16 weeks]
• Fat mass [Time frame: 16 weeks]
• Plasma amino acids [Time frame: 16 weeks.]
• Fat-free mass [Time frame: 16 weeks]
• Bone mineral density [Time frame: 16 weeks]
• Weight [Time frame: 16 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Basic science

Study locations

United States · 2 centers

• Don tyson Center for Agricultural Sciencers — Fayetteville
• University of Arkansas — Fayetteville

Identifiers

NCT: NCT06849817 · PROWELL - 532739 · AWD-104591

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗