The Impact of Beef on Muscle Fatigue in Older Adults

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05860088

Collaborator

(none)

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Weakness Muscle; Fatigue, Heart Older Adults	Other: Beef Diet Other: Vegetarian Diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Beef Diet Participants will be randomized to consume the beef diet for 8 weeks. After a 2-week period, participants will cross-over to consume the vegetarian diet for 8 weeks.	Other: Beef Diet Controlled-Feeding Diet Intervention
Experimental: Vegetarian Diet Participants will be randomized to consume the vegetarian diet for 8 weeks. After a 2-week period, participants will cross-over to consume the beef diet for 8 weeks.	Other: Vegetarian Diet Controlled-Feeding Diet Intervention

Arm

Intervention/Treatment

Experimental: Beef Diet

Participants will be randomized to consume the beef diet for 8 weeks. After a 2-week period, participants will cross-over to consume the vegetarian diet for 8 weeks.

Other: Beef Diet

Controlled-Feeding Diet Intervention

Experimental: Vegetarian Diet

Participants will be randomized to consume the vegetarian diet for 8 weeks. After a 2-week period, participants will cross-over to consume the beef diet for 8 weeks.

Other: Vegetarian Diet

Controlled-Feeding Diet Intervention

Outcome Measures

Primary Outcome Measures

The change in muscle strength [Weeks 0, 4, 8]
Sit-to-stand
The change in muscle function [Weeks 0,4,6]
6-minute walk

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

Ages 60-75 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 >50 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