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The Impact of Beef on Muscle Fatigue in Older Adults

Primary Purpose

Muscle Weakness, Muscle; Fatigue, Heart, Older Adults

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beef Diet
Vegetarian Diet
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring Body Composition, Older Adults, Diet, Vegetarian, Meat, Beef, Controlled Feeding, Intervention

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University BloomingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Beef Diet

Vegetarian Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The change in muscle strength
Sit-to-stand
The change in muscle function
6-minute walk

Secondary Outcome Measures

Full Information

First Posted
April 25, 2023
Last Updated
August 15, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05860088
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Muscle; Fatigue, Heart, Older Adults
Keywords
Body Composition, Older Adults, Diet, Vegetarian, Meat, Beef, Controlled Feeding, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beef Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Vegetarian Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Beef Diet
Intervention Description
Controlled-Feeding Diet Intervention
Intervention Type
Other
Intervention Name(s)
Vegetarian Diet
Intervention Description
Controlled-Feeding Diet Intervention
Primary Outcome Measure Information:
Title
The change in muscle strength
Description
Sit-to-stand
Time Frame
Weeks 0, 4, 8
Title
The change in muscle function
Description
6-minute walk
Time Frame
Weeks 0,4,6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cydne A Perry, PhD
Phone
812 855 5087
Email
cydperry@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cydne A Perry, PhD
Organizational Affiliation
Indiana University, Bloomington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Bloomington
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cydne A Perry, PhD
Phone
812-855-5087
Email
cydperry@iu.edu
First Name & Middle Initial & Last Name & Degree
Cydne A Perry, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Impact of Beef on Muscle Fatigue in Older Adults

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