NCT05860088

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2025

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

April 25, 2023

Last Update Submit

April 30, 2026

Conditions

Keywords

Body CompositionOlder AdultsDietVegetarianMeatBeefControlled FeedingIntervention

Outcome Measures

Primary Outcomes (4)

  • Change in Sit-to-Stand Chair Test

    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

    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

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

    Through study completion, approximately 16 weeks

  • Adherence to Study Diets

    Participant adherence to the study diets will be evaluated.

    Through study completion, approximately 16 weeks

Secondary Outcomes (4)

  • Change in Lactate

    Weeks 0, 4, 8

  • Change in Beta-Alanine

    Weeks 0, 4, 8

  • Change in Carnosine

    Weeks 0, 4, 8

  • Change in Amino Acids

    Weeks 0, 4, 8

Study Arms (2)

Beef Diet

EXPERIMENTAL

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

Vegetarian Diet

EXPERIMENTAL

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

Interventions

Controlled-Feeding Diet Intervention

Beef Diet

Controlled-Feeding Diet Intervention

Vegetarian Diet

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Bloomington

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Muscle WeaknessFatigue

Interventions

Diet, Vegetarian

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Cydne A Perry, PhD

    Indiana University, Bloomington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Applied Health Sciences

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 16, 2023

Study Start

July 10, 2023

Primary Completion

November 21, 2025

Study Completion

November 21, 2025

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations