Clinical trial NCT05860088: The Impact of Beef on Muscle Fatigue in Older Adults
Official title: The Effect of Beta-Alanine and Carnosine From Beef Intake on Muscle Fatigue in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Weakness
Muscle; Fatigue, Heart
Older Adults
Keywords: Body Composition
Older Adults
Diet
Vegetarian
Meat
Beef
Controlled Feeding
Intervention
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Sit-to-Stand Chair Test
timeFrame: Weeks 0, 4, 8
measure: Change in 6-minute walk
timeFrame: Weeks 0, 4, 8
measure: Retention of Participants
timeFrame: Through study completion, approximately 16 weeks
measure: Adherence to Study Diets
timeFrame: Through study completion, approximately 16 weeks
Secondary outcomes:
measure: Change in Lactate
timeFrame: Weeks 0, 4, 8
measure: Change in Beta-Alanine
timeFrame: Weeks 0, 4, 8
measure: Change in Carnosine
timeFrame: Weeks 0, 4, 8
measure: Change in Amino Acids
timeFrame: Weeks 0, 4, 8
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University Bloomington
state: Indiana
Study officials:
affiliation: Indiana University, Bloomington
name: Cydne A Perry, PhD
role: PRINCIPAL_INVESTIGATOR
References: