Recruiting

Protein & Exercise

Sponsor:

University of Arkansas, Fayetteville

Code:

NCT06849817

Conditions

Postmenopausal

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Diet - higher protein

Physical activity and resistance training

Study Details

Brief summary:

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

Conditions

Postmenopausal

Study ID

NCT06849817

Start date

Oct 1, 2024

Status verified date

Feb, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Control

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.

experimental: Protein (Beef)

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).

experimental: Protein (Beef) + Physical Activity

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.

Interventions

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)

Physical activity and resistance training

150 minutes of physical activity including strength training 3 times per week

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jamie Baum, PhD

479-575-4474baum@uark.edu

Samuel Attu, MS

sattu@uark.edu

Locations

Don tyson Center for Agricultural Sciencers

Recruiting

Fayetteville, Arkansas, United States, 72704

Contacts

Jean-Francios Meullenet, PhD

479-575jfmeull@uark.edu

Principal Investigator:

Jamie Baum

University of Arkansas

Recruiting

Fayetteville, Arkansas, United States, 72704

Contacts

Jamie Baum, PhD

479-575-4474baum@uark.edu

Ro Windwalker

479-575-2208irb@uark.edu

Principal Investigator:

Jamie Baum, PhD

More Information

Sponsor

University of Arkansas, Fayetteville

Last update posted

Feb 27, 2025

Last verified

Feb, 2025

Keywords

  • Postmenopausal
  • Protein
  • Mood
  • Sleep
  • Wellbeing
  • Body composition
  • Amino acids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas, Fayetteville on 2025-02-27.