Clinical trial NCT06849817: Protein and Exercise for Postmenopausal Women's Wellbeing
Official title: PRO-WELL: Protein and Exercise for Postmenopausal Women's Wellbeing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postmenopausal
Keywords: Postmenopausal
Protein
Mood
Sleep
Wellbeing
Body composition
Amino acids
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: Sleep Quality and Duration
timeFrame: 16 weeks
measure: Mood
timeFrame: 16 weeks
measure: Qualify of Life Assessment
timeFrame: 16 weeks
Secondary outcomes:
measure: Height
timeFrame: 16 weeks
measure: Dietary intake
timeFrame: 16 weeks
measure: Fat mass
timeFrame: 16 weeks
measure: Plasma amino acids
timeFrame: 16 weeks.
measure: Fat-free mass
timeFrame: 16 weeks
measure: Bone mineral density
timeFrame: 16 weeks
measure: Weight
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Don tyson Center for Agricultural Sciencers
state: Arkansas
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: University of Arkansas System Division of Agriculture
name: Jamie Baum
role: PRINCIPAL_INVESTIGATOR
References: