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

Menopause Related Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714462
• Other study ID #: 275449
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: July 2023
• Source: University of Arkansas
• Contact: Amanda Gwin, PA-C
• Phone: 5015265734
• Email: algwin[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause Related Conditions

Intervention

Other:
• meals consisting of primarily animal protein sources
an omnivorous diet
• meals consisting of plant protein sources
an herbivorous diet

Locations

Country	Name	City	State
United States	Center of Translational Research in Aging and Longevity	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net change in muscle protein synthesis (% per day).	Change in net muscle protein synthesis between groups.	Study meals are eaten for 5 consecutive days.