NCT03409380

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

February 8, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2019

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

January 11, 2018

Last Update Submit

September 13, 2022

Conditions

ProteinAmino AcidArginine

Keywords

growth hormone

Outcome Measures

Primary Outcomes (1)

  • Growth Hormone

    Change in GH

    baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs

Study Arms (2)

Arginine

EXPERIMENTAL

Arginine drink provided 1 time. There is about 10 g of arginine in the product.

Dietary Supplement: Arginine Drink

Placebo

PLACEBO COMPARATOR

Placebo drink provided 1 time.

Dietary Supplement: Plain Drink

Interventions

Arginine DrinkDIETARY_SUPPLEMENT

10 g of arginine in a formulated drink

Arginine
Plain DrinkDIETARY_SUPPLEMENT

formulated drink

Placebo

Eligibility Criteria

Age18 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: double - blind randomized, crossover design trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Professor

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 24, 2018

Study Start

February 8, 2018

Primary Completion

July 8, 2019

Study Completion

July 8, 2019

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)