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Search / Trial NCT06849817

Protein and Exercise for Postmenopausal Women's Wellbeing

Launched by UNIVERSITY OF ARKANSAS, FAYETTEVILLE · Feb 24, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Postmenopausal Protein Mood Sleep Wellbeing Body Composition Amino Acids

ClinConnect Summary

This clinical trial is looking to find out if a higher protein diet, including eating beef once a day, along with resistance exercises, can improve the wellbeing of postmenopausal women. The researchers want to see if this combination can help with mood and sleep, and if there are other health benefits as well. They will be comparing three groups of postmenopausal women: one group will continue their usual daily routine, another group will follow a higher protein diet, and the third group will do both the higher protein diet and resistance training.

To participate, women need to be at least 50 years old and must have been postmenopausal for at least a year. They should be physically active, engaging in activities like walking, yoga, or cycling a few times a week. Participants will follow the higher protein diet for 16 weeks and do resistance exercises at home for the same amount of time. They will also keep a diary to track what they eat, how they sleep, and how they feel. Health checks will happen every four weeks to monitor progress. However, certain health conditions and dietary restrictions may prevent some women from joining. If you think you might be eligible or are interested in improving your health through diet and exercise, this trial could be a great opportunity!

Gender

FEMALE

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.

About University Of Arkansas, Fayetteville

The University of Arkansas, Fayetteville, is a leading research institution dedicated to advancing health and medical knowledge through innovative clinical trials. With a strong commitment to scientific excellence, the university leverages its extensive academic resources and interdisciplinary collaboration to conduct rigorous research that addresses pressing health challenges. The institution fosters a supportive environment for both researchers and participants, ensuring ethical standards and the highest quality of care throughout the trial process. As a sponsor, the University of Arkansas aims to contribute to the development of new therapies and interventions that enhance patient outcomes and improve public health.

Locations

Fayetteville, Arkansas, United States

Fayetteville, Arkansas, United States

Patients applied

0 patients applied

Trial Officials

Jamie Baum

Principal Investigator

University of Arkansas System Division of Agriculture

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported