RECRUITING

Protein and Exercise for Postmenopausal Women's Wellbeing

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06849817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Postmenopausal women aged 50 years and older (at least 12 months since last menstrual cycle)
  2. * 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.
  1. * Food allergies
  2. * Dietary restrictions (e.g., vegan, vegetarian, lactose intolerance, etc.)
  3. * Diet-related conditions that would prevent them from consuming a higher protein dietary intake (e.g., impaired liver function, kidney disease)
  4. * Participants consuming more than 0.8 g protein/kg/body weight per day (determined by 24-hour dietary recall)
  5. * Underweight (BMI \< 18.5)
  6. * Taking nutritional supplements
  7. * Currently smoking or vaping
  8. * Use marijuana
  9. * Drink more than 4 alcoholic beverages a week
  10. * Take medications that may interfere with the primary outcomes of the dietary intervention (e.g., antidepressants, sleep medication, etc.)
  11. * Sleep apnea
  12. * Pittsburgh Sleep Quality Index (PSQI) global score \>5 via or sleep \> 7 hours a night
  13. * 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.

Contacts and Locations

Study Contact

Jamie Baum, PhD
CONTACT
479-575-4474
baum@uark.edu
Samuel Attu, MS
CONTACT
sattu@uark.edu

Principal Investigator

Jamie Baum
PRINCIPAL_INVESTIGATOR
University of Arkansas System Division of Agriculture

Study Locations (Sites)

Don tyson Center for Agricultural Sciencers
Fayetteville, Arkansas, 72704
United States
University of Arkansas
Fayetteville, Arkansas, 72704
United States

Collaborators and Investigators

Sponsor: University of Arkansas, Fayetteville

  • Jamie Baum, PRINCIPAL_INVESTIGATOR, University of Arkansas System Division of Agriculture

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Postmenopausal