SarcopeniaNCT04830514
Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
A study testing Recommended Dietary Allowance of Protein, Habitual protein intake and Optimal Protein Intake in people with Sarcopenia, run by University of Arkansas at 1 site in United States.
Trial summary
A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Recommended Dietary Allowance of Protein, Habitual protein intake and Optimal Protein Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≤ 35 kg/m2
- Capable of providing informed consent
- COVID-19 negative and/or asymptomatic
Who cannot join
- Subject who does not/will not eat animal protein sources.
- Body mass index > 35.
- History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
- Use of insulin to control blood sugar level.
- Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- Currently using prescription blood thinning medications.
- Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.
- Unwilling to avoid using protein or amino-acid supplements during participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns.
Read the detailed description
Current dietary patterns of older Americans will be augmented by readily available quality protein sources. Investigators will observe the effects of recommended and common protein intakes on the maintenance of whole-body protein balance and potential for muscle protein anabolism.
3 groups of 10 older subjects will be studied during daily protein intakes. Study duration per subject will be about 2 weeks.
- Conditions
- Sarcopenia
- Being tested
- Recommended Dietary Allowance of Protein, Habitual protein intake, Optimal Protein Intake
- Keywords
- muscle loss, protein, animal-based protein
- Medical subject headings
- Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommended Dietary Allowance of ProteinOther
Also called RDA
0.8 g/kg/day protein intake
Habitual protein intakeOther
Also called NHANES
1.0 g/kg/day protein intake
Optimal Protein IntakeOther
Also called OPI
1.5 g/kg/day protein intake
| Study group | Role | What they receive |
|---|---|---|
| Recommended dietary allowance (RDA) for protein | Experimental | (RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Receives: Other: Recommended Dietary Allowance of Protein |
| Habitual protein intake consistent with population level norms | Experimental | (NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Receives: Other: Habitual protein intake |
| Optimal protein intake (OPI) | Experimental | (OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Receives: Other: Optimal Protein Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Body Protein Turnover
Isotope Tracer
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start27 May 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arny A Ferrando, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830514
- Sponsor's protocol ID
- 262424
- Status last verified
- Oct 2022
- First submitted
- 31 Mar 2021
- Last updated
- 24 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Church DD, Hirsch KR, Kviatkovsky SA, Matthews JJ, Henderson RA, Azhar G, Wolfe RR, Ferrando AA. Effect of 3 Different Daily Protein Intakes in a 2-Meal Eating Pattern on Protein Turnover in Middle Age and Older Adults: A Randomized Controlled Trial. J Nutr. 2025 May;155(5):1364-1372. doi: 10.1016/j.tjnut.2024.12.025. Epub 2024 Dec 28.
PubMed 39736329
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
- ClinicalTrials.gov ID
- NCT04830514
- Acronym / sponsor ID
- 262424
- Conditions
- Sarcopenia
- Keywords
- muscle loss, protein, animal-based protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Posted 24 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns.
Detailed description
Current dietary patterns of older Americans will be augmented by readily available quality protein sources. Investigators will observe the effects of recommended and common protein intakes on the maintenance of whole-body protein balance and potential for muscle protein anabolism.
3 groups of 10 older subjects will be studied during daily protein intakes. Study duration per subject will be about 2 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recommended dietary allowance (RDA) for protein | Experimental | Other: Recommended Dietary Allowance of Protein(RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. |
| Habitual protein intake consistent with population level norms | Experimental | Other: Habitual protein intake(NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. |
| Optimal protein intake (OPI) | Experimental | Other: Optimal Protein Intake(OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≤ 35 kg/m2
- Capable of providing informed consent
- COVID-19 negative and/or asymptomatic
Key exclusion criteria (8 listed)
- Subject who does not/will not eat animal protein sources.
- Body mass index > 35.
- History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
- Use of insulin to control blood sugar level.
- Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
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 |
|---|---|---|
| Recommended Dietary Allowance of ProteinAlso: RDA0.8 g/kg/day protein intake | Other | Recommended dietary allowance (RDA) for protein |
| Habitual protein intakeAlso: NHANES1.0 g/kg/day protein intake | Other | Habitual protein intake consistent with population level norms |
| Optimal Protein IntakeAlso: OPI1.5 g/kg/day protein intake | Other | Optimal protein intake (OPI) |
Primary outcome
Whole Body Protein Turnover
Time frame: 24 hour
Isotope Tracer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39736329Church DD, Hirsch KR, Kviatkovsky SA, Matthews JJ, Henderson RA, Azhar G, Wolfe RR, Ferrando AA. Effect of 3 Different Daily Protein Intakes in a 2-Meal Eating Pattern on Protein Turnover in Middle Age and Older Adults: A Randomized Controlled Trial. J Nutr. 2025 May;155(5):1364-1372. doi: 10.1016/j.tjnut.2024.12.025. Epub 2024 Dec 28.
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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.
Arny A Ferrando, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommended Dietary Allowance of Protein, Habitual protein intake and Optimal Protein Intake in people with Sarcopenia, run by University of Arkansas 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 3 inclusion and 8 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 24 Aug 2023. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Whole Body Protein Turnover (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04830514, which also lists 1 linked publication.
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 24 Aug 2023.