Single Low-Dose of Supplement Amino Acid

Growth Hormone Clinical Trial

Official title:

Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540773
• Other study ID #: PBRC 10043
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: October 2018
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amino Acid
• Growth Hormone

Intervention

Drug:
• Amino acid supplement
An orally administered supplement of the proprietary amino acid derivative
• Placebo
A non-active orally administered supplement of the proprietary amino acid derivative

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline of Growth Hormone	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.	0-120 minutes, at Baseline and post dose, week 1 and week 3
Primary	Area Under the Curve of Growth Hormone Over Baseline	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.	0-120 minutes, at Baseline and post dose, week 1 and week 3
Secondary	Insulin-like Growth Factor 1	Measure IGF-1 8 hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebo	8 hours following administration