Muscle WeaknessNCT05860088
The Impact of Beef on Muscle Fatigue in Older Adults
A study testing Beef Diet and Vegetarian Diet in people with Muscle Weakness and Muscle; Fatigue, Heart, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness, Muscle; Fatigue, Heart, Older Adults
- What is being tested?
- Beef Diet and Vegetarian Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to 21 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Bloomington
Bloomington, Indiana, 47405
About this study
Official title: The Effect of Beta-Alanine and Carnosine From Beef Intake on Muscle Fatigue in Older Adults
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.
Read more
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.
- Conditions
- Muscle Weakness, Muscle; Fatigue, Heart, Older Adults
- Being tested
- Beef Diet, Vegetarian Diet
- Keywords
- Body Composition, Older Adults, Diet, Vegetarian, Meat, Beef, Controlled Feeding, Intervention
- Medical subject headings
- Muscle Weakness, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beef DietOther
Controlled-Feeding Diet Intervention
Vegetarian DietOther
Controlled-Feeding Diet Intervention
| Study group | Role | What they receive |
|---|---|---|
| Beef Diet | Experimental | 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. Receives: Other: Beef Diet |
| Vegetarian Diet | Experimental | 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. Receives: Other: Vegetarian Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sit-to-Stand Chair Test
The change in muscle strength observed in each diet condition will be evaluated through the Sit-To-Stand Chair Test. The number of times a participant comes to a full standing position (from a seated position) in 60 seconds will be recorded.
Measured: Weeks 0, 4, 8
Change in 6-minute walk
The change in muscle strength observed in each diet condition will be evaluated through the 6-Minute-Walk-Test. The distance walked by a participant during the 6 minute test period will be recorded.
Measured: Weeks 0, 4, 8
Retention of Participants
The percentage of randomized participants completing the 16-week diet intervention trial.
Measured: Through study completion, approximately 16 weeks
Adherence to Study Diets
Participant adherence to the study diets will be evaluated.
Measured: Through study completion, approximately 16 weeks
Secondary outcomes (4)
Change in Lactate
Measures of muscle fatigue will be evaluated through blood biomarkers.
Measured: Weeks 0, 4, 8
Change in Beta-Alanine
Measures of muscle fatigue will be evaluated through blood biomarkers.
Measured: Weeks 0, 4, 8
Change in Carnosine
Measures of muscle fatigue will be evaluated through blood biomarkers.
Measured: Weeks 0, 4, 8
Change in Amino Acids
Measures of muscle fatigue will be evaluated through blood biomarkers.
Measured: Weeks 0, 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start10 Jul 2023
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cydne Perry, Indiana University
- Investigators
- Cydne A Perry, PhD, Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860088
- Sponsor's protocol ID
- 14941
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2023
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Beta-Alanine and Carnosine From Beef Intake on Muscle Fatigue in Older Adults
- ClinicalTrials.gov ID
- NCT05860088
- Acronym / sponsor ID
- 14941
- Conditions
- Muscle Weakness, Muscle; Fatigue, Heart, Older Adults
- Keywords
- Body Composition, Older Adults, Diet, Vegetarian, Meat, Beef, Controlled Feeding, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beef Diet | Experimental | Other: Beef DietParticipants 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. |
| Vegetarian Diet | Experimental | Other: Vegetarian DietParticipants 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beef DietControlled-Feeding Diet Intervention | Other | Beef Diet |
| Vegetarian DietControlled-Feeding Diet Intervention | Other | Vegetarian Diet |
Primary outcome
Change in Sit-to-Stand Chair Test
Time frame: Weeks 0, 4, 8
The change in muscle strength observed in each diet condition will be evaluated through the Sit-To-Stand Chair Test. The number of times a participant comes to a full standing position (from a seated position) in 60 seconds will be recorded.
Change in 6-minute walk
Time frame: Weeks 0, 4, 8
The change in muscle strength observed in each diet condition will be evaluated through the 6-Minute-Walk-Test. The distance walked by a participant during the 6 minute test period will be recorded.
Retention of Participants
Time frame: Through study completion, approximately 16 weeks
The percentage of randomized participants completing the 16-week diet intervention trial.
Adherence to Study Diets
Time frame: Through study completion, approximately 16 weeks
Participant adherence to the study diets will be evaluated.
4 secondary outcomes
Change in Lactate
Time frame: Weeks 0, 4, 8
Change in Beta-Alanine
Time frame: Weeks 0, 4, 8
Change in Carnosine
Time frame: Weeks 0, 4, 8
Change in Amino Acids
Time frame: Weeks 0, 4, 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cydne A Perry, PhD principal investigator
Indiana University, Bloomington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beef Diet and Vegetarian Diet in people with Muscle Weakness and Muscle; Fatigue, Heart, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sit-to-Stand Chair Test (time frame: Weeks 0, 4, 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.