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Completed

NCT Number: NCT05860088

The Impact of Beef 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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Bloomington

Bloomington, Indiana, 47405, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beef Diet

Other

Controlled-Feeding Diet Intervention

Vegetarian Diet

Other

Controlled-Feeding Diet Intervention

Primary outcomes

  1. 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.

  2. 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.

  3. Retention of Participants

    Time frame: Through study completion, approximately 16 weeks

    The percentage of randomized participants completing the 16-week diet intervention trial.

  4. Adherence to Study Diets

    Time frame: Through study completion, approximately 16 weeks

    Participant adherence to the study diets will be evaluated.

Secondary outcomes

  1. Change in Lactate

    Time frame: Weeks 0, 4, 8

    Measures of muscle fatigue will be evaluated through blood biomarkers.

  2. Change in Beta-Alanine

    Time frame: Weeks 0, 4, 8

    Measures of muscle fatigue will be evaluated through blood biomarkers.

  3. Change in Carnosine

    Time frame: Weeks 0, 4, 8

    Measures of muscle fatigue will be evaluated through blood biomarkers.

  4. Change in Amino Acids

    Time frame: Weeks 0, 4, 8

    Measures of muscle fatigue will be evaluated through blood biomarkers.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 16, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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