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Single Low-Dose of Supplement Amino Acid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 23, 2012
First Posted Date  ICMJE February 29, 2012
Results First Submitted Date  ICMJE November 14, 2014
Results First Posted Date  ICMJE March 21, 2017
Last Update Posted Date October 22, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2012)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2012)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Low-Dose of Supplement Amino Acid
Official Title  ICMJE Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Growth Hormone
  • Amino Acid
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Tam CS, Johnson WD, Rood J, Heaton AL, Greenway FL. Increased Human Growth Hormone After Oral Consumption of an Amino Acid Supplement: Results of a Randomized, Placebo-Controlled, Double-Blind, Crossover Study in Healthy Subjects. Am J Ther. 2019 Mar 8. doi: 10.1097/MJT.0000000000000893. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2012)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01540773
Other Study ID Numbers  ICMJE PBRC 10043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Frank Greenway, Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date October 2018

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