Protein and Exercise for Postmenopausal Women's Wellbeing

NCT ID: NCT06849817

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-06-30

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

Conditions

Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Diet - higher protein

Intervention Type: 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)

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.

Group Type: EXPERIMENTAL

Diet - higher protein

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Interventions

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)

Intervention Type: OTHER

Physical activity and resistance training

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

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas, Fayetteville

OTHER

Sponsor Role: lead

Responsible Party

Jamie Baum

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamie Baum

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas System Division of Agriculture

Locations

Don tyson Center for Agricultural Sciencers

Fayetteville, Arkansas, United States

Site Status: RECRUITING

University of Arkansas

Fayetteville, Arkansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jamie Baum, PhD

Role: CONTACT

baum@uark.edu

479-575-4474

Samuel Attu, MS

Role: CONTACT

sattu@uark.edu

Facility Contacts

Jean-Francios Meullenet, PhD

Role: primary

jfmeull@uark.edu

479-575 ext. 479-502-9801

Jamie Baum, PhD

Role: primary

baum@uark.edu

479-575-4474

Ro Windwalker

Role: backup

irb@uark.edu

479-575-2208

Other Identifiers

AWD-104591

Identifier Type: OTHER

Identifier Source: secondary_id

PROWELL - 532739

Identifier Type: -

Identifier Source: org_study_id