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Single Low-Dose of Supplement Amino Acid

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ClinicalTrials.gov Identifier: NCT01540773
Recruitment Status : Completed
First Posted : February 29, 2012
Results First Posted : March 21, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, 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.

Condition or disease Intervention/treatment Phase
Growth Hormone Amino Acid Drug: Amino acid supplement Drug: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.
Study Start Date : October 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Name: SeroVital™

Placebo Comparator: Placebo
Non-Active
Drug: Placebo
A non-active orally administered supplement of the proprietary amino acid derivative
Other Name: non-active




Primary Outcome Measures :
  1. Percent Change of Growth Hormone Over Baseline [ Time Frame: 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.

  2. Area Under the Curve of Growth Hormone Over Baseline [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540773


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center

Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01540773     History of Changes
Other Study ID Numbers: PBRC 10043
First Posted: February 29, 2012    Key Record Dates
Results First Posted: March 21, 2017
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by Frank Greenway, Pennington Biomedical Research Center:
growth hormone