The Impact of Beef on Muscle Fatigue in Older Adults

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860088
• Other study ID #: 14941
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fatigue
• Muscle Weakness
• Muscle; Fatigue, Heart
• Older Adults

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