The Impact of Beef on Muscle Fatigue in Older Adults

February 7, 2024 updated by: Cydne Perry, Indiana University

The Effect of Beta-Alanine and Carnosine From Beef Intake on Muscle Fatigue in Older Adults

The goal of this controlled-feeding cross-over diet intervention is to compare a beef diet to a vegetarian diet on muscle fatigue in older adults. The aims are:

AIM 1: To test the hypothesis that muscle fatigue is attenuated in older adults consuming beef compared to older adults consuming a plant-based diet.

AIM2: To test the hypothesis that daily beef consumption improves biochemical indicators related to muscle fatigue.

Participants will be randomized to consume either a beef-based diet or vegetarian diet under controlled-feeding conditions for 8 weeks. After a 2-week washout period, participants will cross-over to consume either the beef diet or vegetarian diet for 8 weeks. Body composition and functional muscle outcomes will be measured during each 8-week feeding period. Blood samples will also be collected.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cydne A Perry, PhD
  • Phone Number: 812 855 5087
  • Email: cydperry@iu.edu

Study Locations

  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Recruiting
        • Indiana University Bloomington
        • Contact:
        • Principal Investigator:
          • Cydne A Perry, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Ages 60-85 years
  • Ability to eat study diet meals for a total of 16 weeks
  • Ability to perform sit-to-stand chair and 6-minute walking tests based on results from PAR-Q questionnaire
  • Ability to provide fasted blood samples
  • Access to transportation
  • Willing to abstain from alcohol consumption and/or use illicit drug use for each 8-week intervention period
  • Ability to consent to participating in this study
  • English-speaking
  • Body mass index between 18.5 (normal) and 39.9 (obese) kg/m2
  • Minimum total body weight of 110 pounds
  • Non-anemia hemoglobin values: Females - >12.0 grams/dL; Men - >13.0 grams/dL
  • Able to ambulate without assistance
  • Physician's clearance for study participation (required prior to baseline testing)

Exclusion Criteria

  • Inability or refusal to sign the informed consent
  • Significant orthopedic limitations or other contraindications to exercise
  • Inability or refusal to perform muscle fatigue tests
  • Has dietary restrictions that prevent to consumption of beef, soy and/or wheat
  • Has liver or kidney complications
  • Live or work >25 miles from Bloomington study site or does not have transportation to the study site
  • Anticipate elective surgery during the study period
  • Diagnosis of progressive neurological disorders, musculoskeletal disorders, osteoarthritis, rheumatoid arthritis
  • Fracture or serious injury in the last 6 months
  • Stroke, revascularization, deep vein thrombosis, or pulmonary embolism in the past 12 months
  • Severe cardiovascular disease, uncontrolled systemic hypertension, chronic pulmonary disease
  • Plan to move residence or travel out of the local area during the study period
  • Current use of anti-coagulants (e.g. Coumadin or Warfarin)
  • Current use of prescription medications that affect heart rate or blood vessel dilation
  • Psychological or social characteristics that would interfere with their ability to fully participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beef Diet
Participants will be randomized to consume the beef diet for 8 weeks. After a 2-week period, participants will cross-over to consume the vegetarian diet for 8 weeks.
Other: Beef Diet
Controlled-Feeding Diet Intervention
Experimental: Vegetarian Diet
Participants will be randomized to consume the vegetarian diet for 8 weeks. After a 2-week period, participants will cross-over to consume the beef diet for 8 weeks.
Other: Vegetarian Diet
Controlled-Feeding Diet Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sit-to-Stand Chair Test
Time Frame: Weeks 0, 4, 8
The change in muscle strength observed in each diet condition will be evaluated through the Sit-To-Stand Chair Test. The number of times a participant comes to a full standing position (from a seated position) in 60 seconds will be recorded.
Weeks 0, 4, 8
Change in 6-minute walk
Time Frame: Weeks 0, 4, 8
The change in muscle strength observed in each diet condition will be evaluated through the 6-Minute-Walk-Test. The distance walked by a participant during the 6 minute test period will be recorded.
Weeks 0, 4, 8
Retention of Participants
Time Frame: Through study completion, approximately 16 weeks
The percentage of randomized participants completing the 16-week diet intervention trial.
Through study completion, approximately 16 weeks
Adherence to Study Diets
Time Frame: Through study completion, approximately 16 weeks
Participant adherence to the study diets will be evaluated.
Through study completion, approximately 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lactate
Time Frame: Weeks 0, 4, 8
Measures of muscle fatigue will be evaluated through blood biomarkers.
Weeks 0, 4, 8
Change in Beta-Alanine
Time Frame: Weeks 0, 4, 8
Measures of muscle fatigue will be evaluated through blood biomarkers.
Weeks 0, 4, 8
Change in Carnosine
Time Frame: Weeks 0, 4, 8
Measures of muscle fatigue will be evaluated through blood biomarkers.
Weeks 0, 4, 8
Change in Amino Acids
Time Frame: Weeks 0, 4, 8
Measures of muscle fatigue will be evaluated through blood biomarkers.
Weeks 0, 4, 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Cydne A Perry, PhD, Indiana University, Bloomington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14941 (Stanford IRB)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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