Muscle Weakness Clinical Trial
Official title:
The Effect of Beta-Alanine and Carnosine From Beef Intake on Muscle Fatigue in Older Adults
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Bloomington | Bloomington | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
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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