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Supplement Amino Acid

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alok K. Gupta, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01540773
First received: February 23, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Growth Hormone
Amino Acid
 Drug: Amino acid supplement
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Quantity of Growth Hormone [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
    Measure human growth hormone at times -30, -15, 0, 30, 60, 90, and 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:
  • Insulin-like growth factor 1 [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
    Measure IGF-1 eight hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebos.


Estimated Enrollment: 16
Study Start Date: October 2011
Estimated Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: amino acid supplement
supplements with the proprietary amino acid derivative blend.
 Drug: Amino acid supplement
An orally administered supplement of the proprietary amino acid derivative
Placebo Comparator: Placebo
Non-Active
 Drug: Placebo
A non-active orally administered supplement of the proprietary amino acid derivative

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 healthy males and 4 healthy females
  • Between 18 and 70 years

Exclusion Criteria:

  • Pregnant or nursing
  • Taking any chronic medication including birth control pills.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540773

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Alok K. Gupta, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01540773     History of Changes
Other Study ID Numbers: PBRC10043
Study First Received: February 23, 2012
Last Updated: February 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
growth hormone

ClinicalTrials.gov processed this record on June 18, 2013