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Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

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ClinicalTrials.gov Identifier: NCT02987868
Recruitment Status : Completed
First Posted : December 9, 2016
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Brief Summary:
In a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hGH) increased 682% above baseline 120 minutes after oral administration of an amino acid-based dietary supplement (SeroVital), p=0.01 vs placebo. In contrast to the mechanism of hGH stimulation by ghrelin, the investigators hypothesize that the supplement suppresses somatostatin, a know inhibitor of both hGH and TSH. To test this hypothesis, the investigators measured triiodothyronine (T3) after administration of the amino acid-base supplement.

Condition or disease Intervention/treatment Phase
Growth Hormone Treatment Aging Drug: Amino acid supplement first day Drug: Placebo first day Drug: Amino acid supplement second day Drug: Placebo second day Not Applicable

Detailed Description:
Two molecular targets that regulate the synthesis and secretion of human growth hormone (hGH) include 1) ghrelin, an endogenous ligand secreted by the stomach that also has appetite-stimulation properties distinct from its hGH-stimulating effects, and 2) somatostatin, a family of 14 and 28 amino acid peptides that act as a potent noncompetitive inhibitor of the release of hGH. the investigators recently reported that oral administration of a 2.9g/dose of SeroVital, a blend of l-lysine HCl, l-arginine HCL, oxo-proline, N-acetyl-l-cysteine, l-glutamine, and schizonepeta (aerial parts) powder, leads to a significant 682% mean increase in endogenous hGH levels in male and female subjects in a period of 120 minutes following acute consumption. In the work presented here, the investigators seek to characterize the mechanistic target associated with this measured increase in endogenous hGH by SeroVital, which the investigators hypothesize to be somatostatin. The investigators test this hypothesis by assaying thyroid function, a secondary inhibition target of somatostatin. The investigators further compare our findings to ghrelin-based hGH secretagogues.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine
Study Start Date : October 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Supplement 1st day, placebo 2nd day
Administration of oral supplement (proprietary amino acid derivative blend). Half of the participants took the Amino acid supplement first day and half of the participants took the Amino acid supplement second day.
Drug: Amino acid supplement first day
An orally administered supplement of the proprietary amino acid derivative
Other Name: SeroVital™

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

Placebo Comparator: Placebo 1st day, supplement 2nd day
Half of the participants took the placebo first day and half of the participants took placebo second day.
Drug: Placebo first day
A non-active orally administered supplement of the proprietary amino acid derivative
Other Name: Non-active

Drug: Amino acid supplement second day
An orally administered supplement of the proprietary amino acid derivative
Other Name: SeroVital™




Primary Outcome Measures :
  1. Percent Change of Triiodthyronine Over Baseline [ Time Frame: 0-120 minutes, at Baseline and post dose, week 1 and week 3 ]
    Measure Triiodthyronine 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:   Yes
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): NCT02987868


Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Frank Greenway, M.D. Pennington Biomedical Research Center

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Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02987868     History of Changes
Other Study ID Numbers: PBRC 10043 - HGH/Somatostatin
First Posted: December 9, 2016    Key Record Dates
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Frank Greenway, Pennington Biomedical Research Center:
Somatostatin
Thyroid Hormone
Growth Hormone

Additional relevant MeSH terms:
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Secretagogues
Physiological Effects of Drugs