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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05860088
Other study ID # 14941
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 10, 2023
Est. completion date December 2024

Study information

Verified date February 2024
Source Indiana University
Contact Cydne A Perry, PhD
Phone 812 855 5087
Email cydperry@iu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility 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 Design


Intervention

Other:
Beef Diet
Controlled-Feeding Diet Intervention
Vegetarian Diet
Controlled-Feeding Diet Intervention

Locations

Country Name City State
United States Indiana University Bloomington Bloomington Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Retention of Participants The percentage of randomized participants completing the 16-week diet intervention trial. Through study completion, approximately 16 weeks
Primary Adherence to Study Diets Participant adherence to the study diets will be evaluated. Through study completion, approximately 16 weeks
Secondary Change in Lactate Measures of muscle fatigue will be evaluated through blood biomarkers. Weeks 0, 4, 8
Secondary Change in Beta-Alanine Measures of muscle fatigue will be evaluated through blood biomarkers. Weeks 0, 4, 8
Secondary Change in Carnosine Measures of muscle fatigue will be evaluated through blood biomarkers. Weeks 0, 4, 8
Secondary Change in Amino Acids Measures of muscle fatigue will be evaluated through blood biomarkers. Weeks 0, 4, 8
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