Supplementation Trial on Arginine With Metabolic Profiling

Not Applicable

Completed

• Conditions: Amino Acid; Protein; Arginine
• Interventions: Dietary Supplement: Arginine Drink; Dietary Supplement: Plain Drink

• Registration Number: NCT03409380
• Lead Sponsor: Pennington Biomedical Research Center

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).

Study Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Study Start: 2018-02-08
• Primary Completion: 2019-07-08
• Study Completion: 2019-07-08
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arginine	Arginine Drink	Arginine drink provided 1 time. There is about 10 g of arginine in the product.
Placebo	Plain Drink	Placebo drink provided 1 time.

Primary Outcome Measures

Name	Time	Method
Growth Hormone	baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs	Change in GH

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States