Supplementation Trial on Arginine With Metabolic Profiling (STAMP)

Pennington Biomedical Research Center

Status

Completed

Conditions

Protein

Arginine

Amino Acid

Treatments

Dietary Supplement: Arginine Drink

Dietary Supplement: Plain Drink

Study type

Interventional

Funder types

Other

Identifiers

NCT03409380

PBRC 2017-027

Details and patient eligibility

About

This study will assess effects of an acute dose of the amino acid arginine on metabolism in healthy young men.

Full 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).

Enrollment

30 patients

Sex

Male

Ages

18 to 39 years old

Volunteers

Accepts Healthy Volunteers

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.