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Single Low-Dose of Supplement Amino Acid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01540773
First received: February 23, 2012
Last updated: January 31, 2017
Last verified: December 2016
  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
Intervention Model: Crossover Assignment
Masking: Participant, 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:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • Insulin-like Growth Factor 1 [ Time Frame: 8 hours following adminstration ]
    Measure IGF-1 eight hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebos.


Enrollment: 16
Study Start Date: October 2011
Study Completion Date: March 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
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

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   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center
  More Information

Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01540773     History of Changes
Other Study ID Numbers: PBRC 10043
Study First Received: February 23, 2012
Results First Received: November 14, 2014
Last Updated: January 31, 2017

Keywords provided by Pennington Biomedical Research Center:
growth hormone

ClinicalTrials.gov processed this record on April 27, 2017