Supplementation Trial on Arginine With Metabolic Profiling

Protein Clinical Trial

— STAMP  

Official title:

Supplementation Trial on Arginine With Metabolic Profiling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409380
• Other study ID #: PBRC 2017-027
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: July 8, 2019

Study information

• Verified date: September 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 8, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amino Acid
• Arginine
• Protein

Intervention

Dietary Supplement:
• Arginine Drink
10 g of arginine in a formulated drink
• Plain Drink
formulated drink

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (5)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Corby K. Martin, Frank L. Greenway, Jennifer C. Rood, Robbie A. Beyl

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth Hormone	Change in GH	baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs