- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03409380
Supplementation Trial on Arginine With Metabolic Profiling (STAMP)
September 13, 2022 updated by: John Apolzan, Pennington Biomedical Research Center
This study will assess effects of an acute dose of the amino acid arginine on metabolism in healthy young men.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- HIV or AIDS
- Uncontrolled CVD/arrhythmia
- Type I or type II diabetes
- Pregnancy (or breastfeeding)
- Diagnosed eating disorder
- Non-normal sleeping patterns
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arginine
Arginine drink provided 1 time.
There is about 10 g of arginine in the product.
|
10 g of arginine in a formulated drink
|
Placebo Comparator: Placebo
Placebo drink provided 1 time.
|
formulated drink
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Growth Hormone
Time Frame: baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs
|
Change in GH
|
baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2018
Primary Completion (Actual)
July 8, 2019
Study Completion (Actual)
July 8, 2019
Study Registration Dates
First Submitted
January 11, 2018
First Submitted That Met QC Criteria
January 17, 2018
First Posted (Actual)
January 24, 2018
Study Record Updates
Last Update Posted (Actual)
September 14, 2022
Last Update Submitted That Met QC Criteria
September 13, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PBRC 2017-027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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