The Impact of Beef on Muscle Fatigue in Older Adults (NCT05860088) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Beef on Muscle Fatigue in Older Adults
United States24 participantsStarted 2023-07-10
Plain-language 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.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Sit-to-Stand Chair Test
Timeframe: Weeks 0, 4, 8
2
Change in 6-minute walk
Timeframe: Weeks 0, 4, 8
3
Retention of Participants
Timeframe: Through study completion, approximately 16 weeks
4
Adherence to Study Diets
Timeframe: Through study completion, approximately 16 weeks