Effects of Beef Consumption on Skeletal Muscle Protein Homeostasis and Inflammatory Factors in Pre- and Postmenopausal Females

This will be a randomized study to determine if animal-based protein-rich food sources can stimulate greater muscle protein turnover and whole-body protein balance and reduce skeletal muscle inflammatory markers in postmenopausal women compared to vegetarian base protein-rich foods.

Study Overview

• Status: Completed
• Conditions: Menopause Related Conditions
• Intervention / Treatment: Other: meals consisting of primarily animal protein sources; Other: meals consisting of plant protein sources

Detailed Description

A randomized cross-sectional controlled trial will be conducted to quantify whole-body and muscle protein turnover and skeletal muscle inflammation following 5-days of consumption of either beef or isonitrogenous plant-based sources of protein in normal/overweight and obese post-menopausal females. A premenopausal normal/overweight group consuming beef containing study meals will also be recruited to serve as a healthy control comparison.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Center of Translational Research in Aging and Longevity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Postmenopausal women ages 50-65 (absence of menstruation for at least 12 months).
2. Premenopausal women ages 35-45 (presence of normal monthly menstruation for the past 12 months).
3. BMI of 20.0 - 34.9 kg/m2.
4. COVID-19 negative and/or asymptomatic

Exclusion Criteria:

1. Any substantial musculoskeletal injuries/diseases that have limited daily activities in the past month.
2. Unable to stop the use of anti-inflammatory drugs for the week prior to and during study.
3. Diagnosed metabolic or hormonal disease (i.e., renal, cardiovascular, thyroid, polycystic ovary syndrome, or type I/II diabetes mellitus).
4. Currently pregnant.
5. Gave birth or was lactating within previous 12 months.
6. Undergone gastric bypass/bariatric surgery.
7. Clinically significant weight gain or loss (>5% change) in the last 12 months.
8. Consuming metabolism-altering drugs or medications (i.e., corticosteroids, stimulants, insulin, thyroid medication).
9. Unable or unwilling to suspend anti-clotting medications including aspirin use for 5 days prior to Visit 4.
10. Participating in >200 minutes/week of vigorous exercise and/or >4 days/week of resistance training.
11. Unwilling to fast overnight.
12. Surgical menopause.
13. Having undergone hormone replacement therapy in the last 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: postmenopausal with normal/overweight BMI that eats primarily beef as their protein source	Other: meals consisting of primarily animal protein sources; an omnivorous diet
Experimental: postmenopausal with normal/overweight BMI that eats vegetables as their protein source	Other: meals consisting of plant protein sources; an herbivorous diet
Experimental: postmenopausal with obese BMI that eats primarily beef as their protein source in study meals	Other: meals consisting of primarily animal protein sources; an omnivorous diet
Experimental: postmenopausal with obese BMI that eats vegetables as their protein source in study meals	Other: meals consisting of plant protein sources; an herbivorous diet
Active Comparator: premenopausal with normal/overweight BMI that eats primarily beef as their protein source	Other: meals consisting of primarily animal protein sources; an omnivorous diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net change in muscle protein synthesis (% per day).	Change in net muscle protein synthesis between groups.	Study meals are eaten for 5 consecutive days.

Collaborators and Investigators

• Sponsor: University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 275449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No