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NCT Number: NCT06849817

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

Recruiting

Interested in participating?

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Key information

Conditions

Postmenopausal

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Don tyson Center for Agricultural Sciencers, Fayetteville, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet - higher protein

Other

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

Behavioral

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

Primary outcomes

  1. Sleep Quality and Duration

    Time frame: 16 weeks

    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

  2. Mood

    Time frame: 16 weeks

    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".

  3. Qualify of Life Assessment

    Time frame: 16 weeks

    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.

Secondary outcomes

  1. Height

    Time frame: 16 weeks

    Height will be measured to the nearest 0.01 cm using a standard stadiometer.

  2. Dietary intake

    Time frame: 16 weeks

    Dietary intake will be measured using 3-day, weighed food records.

  3. Fat mass

    Time frame: 16 weeks

    Fat mass will be measured using dual x-ray absorptiometry.

  4. Plasma amino acids

    Time frame: 16 weeks.

    Plasma amino acid profiles will be measured in the fasted state.

  5. Fat-free mass

    Time frame: 16 weeks

    Fat-free mass will be measured using dual x-ray absorptiometry.

  6. Bone mineral density

    Time frame: 16 weeks

    Bone mineral density will be measured using dual x-ray absorptiometry.

  7. Weight

    Time frame: 16 weeks

    Body weight will be measured to the nearest 0.05 kg using a calibrated scale in the fasted state.

Study contacts

Contact information is provided by the study sponsor or research team.

Jamie Baum, PhD

CONTACT

[email protected]

479-575-4474

Samuel Attu, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Registry information

Official study title

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

Acronym: PROWELL

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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