The Impact of Beef on Muscle Fatigue in Older Adults

NCT ID: NCT05860088

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle Weakness Muscle; Fatigue, Heart Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Beef Diet

Intervention Type OTHER

Controlled-Feeding Diet Intervention

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.

Group Type EXPERIMENTAL

Vegetarian Diet

Intervention Type OTHER

Controlled-Feeding Diet Intervention

Interventions

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Beef Diet

Controlled-Feeding Diet Intervention

Intervention Type OTHER

Vegetarian Diet

Controlled-Feeding Diet Intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Cydne Perry

Assistant Professor Applied Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cydne A Perry, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University, Bloomington

Locations

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Indiana University Bloomington

Bloomington, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cydne A Perry, PhD

Role: CONTACT

812 855 5087

Facility Contacts

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Cydne A Perry, PhD

Role: primary

812-855-5087

Other Identifiers

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14941

Identifier Type: -

Identifier Source: org_study_id

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