HealthyNCT04612400
Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes
A study testing Oral amino acid tracer in people with Healthy, run by University of Arkansas at 1 site in United States.
Trial summary
To evaluate the validity of a continuous oral sip-feeding method of stable isotope tracer for the evaluation of whole-body protein metabolism in response to two different doses of an EAA/whey protein supplement (Low=6.3g and High=12.6g). Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oral amino acid tracer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2020to 6 Sep 2021
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 21-40 years.
- Body weight of ≤ 80kg.
Who cannot join
- History Chronic kidney disease.
- History of dairy allergy or intolerance.
- History of gastric reduction/bypass surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center of Translational Research in Aging and Longevity
Little Rock, Arkansas, 72205
About this study
To evaluate the validity of a continuous oral sip-feeding method of stable isotope tracer for the evaluation of whole-body protein metabolism in response to two different doses of an EAA/whey protein supplement (Low=6.3g and High=12.6g). Results will be compared to those previously determined by constant infusion with the same EAA/whey supplement.
Read the detailed description
This will be a double-blinded, randomized, crossover pilot study to evaluate the validity of a continuous oral sip-feeding of stable isotope tracer method for the evaluation of whole-body protein metabolism. This method will be evaluated using two different amounts of an essential amino acid (EAA) + whey protein supplement on up to six younger, healthy subjects. Stable isotope preparations will be continuously consumed by subjects throughout visits 2 and 3 to enable whole body protein metabolism to be measured.
- Conditions
- Healthy
- Being tested
- Oral amino acid tracer
- Keywords
- Stable Isotopes, Validation, Whole-body protein metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral amino acid tracerOther
Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.
| Study group | Role | What they receive |
|---|---|---|
| Low | Experimental | Low dose (6.3g) EAA/whey protein supplement Receives: Other: Oral amino acid tracer |
| High | Experimental | High dose (12.6g) EAA/whey protein supplement Receives: Other: Oral amino acid tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body Protein Net Balance
grams of protein per 240 minutes as determined using stable isotope ingestion and blood analysis for said isotopes' concentrations.
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start4 Nov 2020
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
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.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blinded, randomized, crossover pilot study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 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
- NCT04612400
- Sponsor's protocol ID
- 260813
- Status last verified
- Dec 2022
- First submitted
- 27 Oct 2020
- Last updated
- 28 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes
- ClinicalTrials.gov ID
- NCT04612400
- Acronym / sponsor ID
- 260813
- Conditions
- Healthy
- Keywords
- Stable Isotopes, Validation, Whole-body protein metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Posted 28 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the validity of a continuous oral sip-feeding method of stable isotope tracer for the evaluation of whole-body protein metabolism in response to two different doses of an EAA/whey protein supplement (Low=6.3g and High=12.6g). Results will be compared to those previously determined by constant infusion with the same EAA/whey supplement.
Detailed description
This will be a double-blinded, randomized, crossover pilot study to evaluate the validity of a continuous oral sip-feeding of stable isotope tracer method for the evaluation of whole-body protein metabolism. This method will be evaluated using two different amounts of an essential amino acid (EAA) + whey protein supplement on up to six younger, healthy subjects. Stable isotope preparations will be continuously consumed by subjects throughout visits 2 and 3 to enable whole body protein metabolism to be measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blinded, randomized, crossover pilot study
| Arm | Type | Receives |
|---|---|---|
| Low | Experimental | Other: Oral amino acid tracerLow dose (6.3g) EAA/whey protein supplement |
| High | Experimental | Other: Oral amino acid tracerHigh dose (12.6g) EAA/whey protein supplement |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 21-40 years.
- Body weight of ≤ 80kg.
Key exclusion criteria (3 listed)
- History Chronic kidney disease.
- History of dairy allergy or intolerance.
- History of gastric reduction/bypass surgery.
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 |
|---|---|---|
| Oral amino acid tracerWhole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer. | Other | High, Low |
Primary outcome
Whole-body Protein Net Balance
Time frame: 240 minutes
grams of protein per 240 minutes as determined using stable isotope ingestion and blood analysis for said isotopes' concentrations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers
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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 Oral amino acid tracer in people with Healthy, 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 2 inclusion and 3 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 28 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 28 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 Net Balance (time frame: 240 minutes). 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 28 Aug 2023.