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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 : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

February 23, 2012
February 29, 2012
November 14, 2014
March 21, 2017
October 22, 2018
October 2011
December 2011   (Final data collection date for primary outcome measure)
  • Change From Baseline of Growth Hormone [ 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.
Quantity of Growth Hormone [ Time Frame: 3 Weeks ]
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.
Complete list of historical versions of study NCT01540773 on ClinicalTrials.gov Archive Site
Insulin-like Growth Factor 1 [ Time Frame: 8 hours following administration ]
Measure IGF-1 8 hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebo
Insulin-like Growth Factor 1 [ Time Frame: 3 Weeks ]
Measure IGF-1 eight hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebos.
Not Provided
Not Provided
 
Single Low-Dose of Supplement Amino Acid
Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
  • Growth Hormone
  • Amino Acid
  • Drug: Amino acid supplement
    An orally administered supplement of the proprietary amino acid derivative
    Other Name: SeroVital™
  • Drug: Placebo
    A non-active orally administered supplement of the proprietary amino acid derivative
    Other Name: non-active
  • Active Comparator: amino acid supplement
    supplements with the proprietary amino acid derivative blend.
    Intervention: Drug: Amino acid supplement
  • Placebo Comparator: Placebo
    Non-Active
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
Same as current
March 2012
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01540773
PBRC 10043
No
Not Provided
Not Provided
Frank Greenway, Pennington Biomedical Research Center
Pennington Biomedical Research Center
Not Provided
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center
Pennington Biomedical Research Center
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP