Protein and Exercise for Postmenopausal Women's Wellbeing (PROWELL)

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

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

Study Overview

• Status: Recruiting
• Conditions: Postmenopausal
• Intervention / Treatment: Other: Diet - higher protein; Behavioral: Physical activity and resistance training

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamie Baum, PhD; Phone Number: 479-575-4474; Email: baum@uark.edu
• Study Contact Backup: Name: Samuel Attu, MS; Email: sattu@uark.edu

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Recruiting
      • University of Arkansas
      • Contact: Jamie Baum, PhD; Phone Number: 479-575-4474; Email: baum@uark.edu
      • Contact: Ro Windwalker; Phone Number: 479-575-2208; Email: irb@uark.edu
      • Contact: Jamie Baum, PhD
    • Fayetteville, Arkansas, United States, 72704
      • Recruiting
      • Don tyson Center for Agricultural Sciencers
      • Contact: Jean-Francios Meullenet, PhD; Phone Number: 479-502-9801 479-575; Email: jfmeull@uark.edu
      • Contact: Jamie Baum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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)
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality and Duration	Sleep quality and duration will be assessed objectively via an ActiGraph triaxial wrist accelerometer GT9X Link (ActiGraph, LLC, Pensacola, FL, USA), a validated method of sleep assessment. Each participant will wear an ActiGraph monitor on the non-dominant wrist for 24 hours/day for seven days (except when bathing or involved in water activities) prior to the start of the intervention and every four weeks throughout the intervention. Accelerometers will be fitted securely on each participant's wrist. Participants will receive sleep diaries to define "time in bed" and "time out of bed." The indicated "start" and "end" points will be used to define a sleep region to be analyzed within the ActiGraph software. Sleep outcomes will be calculated based on epoch-to-epoch sleep/wake algorithms within the defined sleep period. Data will be processed by using the ActiLife Version 6.9.2 software (Pensacola, FL, USA) and sleep will be scored via the Cole-Kripke algorithm. The following	16 weeks
Mood	The Profile of Mood States (POMS) questionnaire will be used to assess mood. POMS consists of 65 questions containing a one-word adjective of mood to measure and identify six affective states. The six identifiable mood/affective states are tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue/-inertia, and confusion-bewilderment. Participants will be instructed to define their mood on a 5-point Likert scale ranging from 0 to 4. The numbers refer to the following descriptive phrases: 0 = Not at all, 1 = A little, 2 = Moderately, 3 = Quite a bit, 4 = Extremely. Prior to the start of the questionnaire each participant will read the following directions: Describe how you have been feeling during the past week including today by circling the number that best describes your present mood with 0 indicating "Not at all," and 4 indicating "Extremely".	16 weeks
Qualify of Life Assessment	Quality of life assessment (QoL) will be measured using the SF-36 questionnaire. The SF-36 relies on participant self-reporting and measures 8 QOL domains which are dichotomized into physical (functioning, role limitations-physical, pain, general health) and mental health (vitality, social functioning, role limitations-emotional, and emotional/mental health). Item scores are converted to a 0-100-point scale; domain scores are derived by averaging individual items within the subscale; and physical composite and mental health composite scores were derived by averaging the four component domains of each. Higher values are indicative of better QoL.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height will be measured to the nearest 0.01 cm using a standard stadiometer.	16 weeks
Dietary intake	Dietary intake will be measured using 3-day, weighed food records.	16 weeks
Fat mass	Fat mass will be measured using dual x-ray absorptiometry.	16 weeks
Plasma amino acids	Plasma amino acid profiles will be measured in the fasted state.	16 weeks.
Fat-free mass	Fat-free mass will be measured using dual x-ray absorptiometry.	16 weeks
Bone mineral density	Bone mineral density will be measured using dual x-ray absorptiometry.	16 weeks
Weight	Body weight will be measured to the nearest 0.05 kg using a calibrated scale in the fasted state.	16 weeks

Collaborators and Investigators

• Sponsor: University of Arkansas, Fayetteville
• Investigators: Principal Investigator: Jamie Baum, University of Arkansas System Division of Agriculture

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Wellbeing; Sleep; Body composition; Protein; Mood; Postmenopausal; Amino acids
• Other Study ID Numbers: PROWELL - 532739; AWD-104591 (Other Identifier: National Cattlemen's Beef Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are planning on sharing IPD but need approval of the plan by the University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No