Single Low-Dose of Supplement Amino Acid

Not Applicable

Completed

• Conditions: Growth Hormone; Amino Acid
• Interventions: Drug: Placebo; Drug: Amino acid supplement

• Registration Number: NCT01540773
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

The purpose of the study is to confirm the results of a prior study that demonstrated pills containing two amino acids which are in foods increased growth hormone and insulin-like growth factor-1.

Detailed Description

Oral supplementation with a key combination of derivatives that has been shown to increase human growth hormone in healthy volunteers peaking at 90 minutes and IGF-1 at 8 hours post-administration.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-12
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-02-29
• Study Completion: 2012-03
• Results First Submitted: 2014-11-14
• Results First Submitted QC: 2017-01-31
• Results First Posted: 2017-03-21
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-18
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• healthy males and healthy females
• Between 18 and 70 years

Exclusion Criteria

• Pregnant or nursing
• Taking any chronic medication including birth control pills.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Non-Active
amino acid supplement	Amino acid supplement	supplements with the proprietary amino acid derivative blend.

Primary Outcome Measures

Name	Time	Method
Change From Baseline of Growth Hormone	0-120 minutes, at Baseline and post dose, week 1 and week 3	Measure human growth hormone at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.
Area Under the Curve of Growth Hormone Over Baseline	0-120 minutes, at Baseline and post dose, week 1 and week 3	Measure human growth hormone at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.

Secondary Outcome Measures

Name	Time	Method
Insulin-like Growth Factor 1	8 hours following administration	Measure IGF-1 8 hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebo

Trial Locations

Locations (1)

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