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Completed

NCT Number: NCT03409380

Supplementation Trial on Arginine With Metabolic Profiling

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

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Key information

Age range

18 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arginine Drink

Dietary Supplement

10 g of arginine in a formulated drink

Plain Drink

Dietary Supplement

formulated drink

Primary outcomes

  1. Growth Hormone

    Time frame: baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs

    Change in GH

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Frank L. Greenway
  • Jennifer C. Rood
  • Martin, Corby, K., M.D.
  • Robbie A. Beyl

Registry information

Acronym: STAMP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2018
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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