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

Sponsor

University of Arkansas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05714462

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Menopause Related Conditions	Other: meals consisting of primarily animal protein sources Other: meals consisting of plant protein sources	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model 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 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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Net change in muscle protein synthesis (% per day). [Study meals are eaten for 5 consecutive days.]
Change in net muscle protein synthesis between groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of Translational Research in Aging and Longevity	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

University of Arkansas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT05714462

Other Study ID Numbers:

275449

First Posted:

Feb 6, 2023

Last Update Posted:

Feb 6, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 6, 2023