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Supplementation Trial on Arginine With Metabolic Profiling

Supplementation Trial on Arginine With Metabolic Profiling

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03409380
Acronym
STAMP
Enrollment
30
Registered
2018-01-24
Start date
2018-02-08
Completion date
2019-07-08
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amino Acid, Arginine, Protein

Keywords

growth hormone

Brief summary

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).

Interventions

DIETARY_SUPPLEMENTArginine Drink

10 g of arginine in a formulated drink

DIETARY_SUPPLEMENTPlain Drink

formulated drink

Sponsors

Jennifer C. Rood
CollaboratorUNKNOWN
Robbie A. Beyl
CollaboratorUNKNOWN
Martin, Corby, K., M.D.
CollaboratorINDIV
Frank L. Greenway
CollaboratorUNKNOWN
Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

double - blind randomized, crossover design trial

Eligibility

Sex/Gender
MALE
Age
18 Years to 39 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Growth Hormonebaseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrsChange in GH

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026