ProteinSTAMPNCT03409380
Supplementation Trial on Arginine With Metabolic Profiling
A study testing Arginine Drink and Plain Drink in people with Protein and Amino Acid, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study will assess effects of an acute dose of the amino acid arginine on metabolism in healthy young men. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Protein, Amino Acid, Arginine
- What is being tested?
- Arginine Drink and Plain Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 8 Jul 2019
- 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 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5 - 25 kg/m2.
- Must be physically active (exercise at least 2 days/week).
- Willing to refrain from alcohol and supplements for the duration of the study.
- Willing to refrain from supplement ingestion, nuts, watermelon, and cracklins (fatback) for the 2 weeks prior to the initial treatment diet through the duration of the study.
Who cannot join
- HIV or AIDS
- Uncontrolled CVD/arrhythmia
- Type I or type II diabetes
- Pregnancy (or breastfeeding)
- Diagnosed eating disorder
- Non-normal sleeping patterns
Show all 16Show fewer
- Chronic neurological condition
- Altered metabolism including growth hormone disorders
- Use of nicotine or tobacco products
- Heavy caffeine use (≥ 350 mg caffeine/d)
- Whole blood donation within previous eight weeks
- Protein supplementation
- Protein wasting disease.
- Exclusionary medications include diuretics, beta-blockers, weight loss medications or diet pills, anti-inflammatory drugs (corticosteroid/ anabolic steroid/NSAID), antipsychotic medication or other medication that may affect fluid balance, metabolism, or body weight.
- Prisoners and adults who are unable to consent will be excluded from the study.
- Lastly any other medical, psychiatric, or behavioral factors in the judgement of the Principle Investigator that may interfere with study participation or the ability to follow the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
This study will assess effects of an acute dose of the amino acid arginine on metabolism in healthy young men.
Read the detailed description
A double - blind randomized, crossover design trial examining arginine vs. placebo beverage treatments will be performed. The primary objective is to determine the effects of arginine assessed by standard laboratory assays and metabolomics. To accomplish the objective standardized meals will be provided for 2 days preceding treatment for dietary consistency. Participants will arrive at the center following a 10-12 hr fast. Blood samples will be collected at baseline (fasting), 1.5 hrs, 3.0 hrs, 6.0 hrs, and 24 hrs post treatment. Plasma prolactin, growth hormone, amino acids, glucose, insulin, triacylglycerols, thyroid hormones (TSH, T3, and T4), sex hormone binding globulin (SHBH), testosterone, cortisol, DHEA, and citrulline will be measured. Metabolomics will be measured at 3 time points for each treatment. Peripheral arterial tonometry (PAT) will also be performed at ~2 hrs following treatment to examine endothelial function in response to nitrous oxide release. In addition, psychological status including fatigue will be assessed using a standardized mood questionnaire (POMS).
- Conditions
- Protein, Amino Acid, Arginine
- Being tested
- Arginine Drink, Plain Drink
- Keywords
- growth hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine DrinkDietary supplement
10 g of arginine in a formulated drink
Plain DrinkDietary supplement
formulated drink
| Study group | Role | What they receive |
|---|---|---|
| Arginine | Experimental | Arginine drink provided 1 time. There is about 10 g of arginine in the product. Receives: Dietary Supplement: Arginine Drink |
| Placebo | Placebo comparator | Placebo drink provided 1 time. Receives: Dietary Supplement: Plain Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Hormone
Change in GH
Measured: baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start8 Feb 2018
- Primary completion8 Jul 2019
- Study completion8 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double - blind randomized, crossover design trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jennifer C. Rood, Robbie A. Beyl, Martin, Corby, K., M.D., Frank L. Greenway
- Responsible party
- Principal investigator, John Apolzan, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409380
- Sponsor's protocol ID
- PBRC 2017-027
- Acronym
- STAMP
- Status last verified
- Sep 2022
- First submitted
- 11 Jan 2018
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation Trial on Arginine With Metabolic Profiling
- ClinicalTrials.gov ID
- NCT03409380
- Acronym / sponsor ID
- STAMP / PBRC 2017-027
- Conditions
- Protein, Amino Acid, Arginine
- Keywords
- growth hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Jennifer C. Rood, Robbie A. Beyl, Martin, Corby, K., M.D., Frank L. Greenway
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 24 Jan 2018 (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.
This study will assess effects of an acute dose of the amino acid arginine on metabolism in healthy young men.
Detailed description
A double - blind randomized, crossover design trial examining arginine vs. placebo beverage treatments will be performed. The primary objective is to determine the effects of arginine assessed by standard laboratory assays and metabolomics. To accomplish the objective standardized meals will be provided for 2 days preceding treatment for dietary consistency. Participants will arrive at the center following a 10-12 hr fast. Blood samples will be collected at baseline (fasting), 1.5 hrs, 3.0 hrs, 6.0 hrs, and 24 hrs post treatment. Plasma prolactin, growth hormone, amino acids, glucose, insulin, triacylglycerols, thyroid hormones (TSH, T3, and T4), sex hormone binding globulin (SHBH), testosterone, cortisol, DHEA, and citrulline will be measured. Metabolomics will be measured at 3 time points for each treatment. Peripheral arterial tonometry (PAT) will also be performed at ~2 hrs following treatment to examine endothelial function in response to nitrous oxide release. In addition, psychological status including fatigue will be assessed using a standardized mood questionnaire (POMS).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double - blind randomized, crossover design trial
| Arm | Type | Receives |
|---|---|---|
| Arginine | Experimental | Dietary Supplement: Arginine DrinkArginine drink provided 1 time. There is about 10 g of arginine in the product. |
| Placebo | Placebo comparator | Dietary Supplement: Plain DrinkPlacebo drink provided 1 time. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 18.5 - 25 kg/m2.
- Must be physically active (exercise at least 2 days/week).
- Willing to refrain from alcohol and supplements for the duration of the study.
- Willing to refrain from supplement ingestion, nuts, watermelon, and cracklins (fatback) for the 2 weeks prior to the initial treatment diet through the duration of the study.
Key exclusion criteria (16 listed)
- HIV or AIDS
- Uncontrolled CVD/arrhythmia
- Type I or type II diabetes
- Pregnancy (or breastfeeding)
- Diagnosed eating disorder
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 |
|---|---|---|
| Arginine Drink10 g of arginine in a formulated drink | Dietary supplement | Arginine |
| Plain Drinkformulated drink | Dietary supplement | Placebo |
Primary outcome
Growth Hormone
Time frame: baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs
Change in GH
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 14 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine Drink and Plain Drink in people with Protein and Amino Acid, run by Pennington Biomedical Research Center 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 4 inclusion and 16 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 14 Sep 2022. 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. Some participants in this study may receive a placebo. 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?
Growth Hormone (time frame: baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs). 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 14 Sep 2022.