Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

Aging Clinical Trial

Official title:

Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987868
• Other study ID #: PBRC 10043 - HGH/Somatostatin
• Status: Completed
• Phase: N/A
• First received: December 6, 2016
• Last updated: February 6, 2018
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2018
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Growth Hormone Treatment

Intervention

Drug:
• Amino acid supplement first day
An orally administered supplement of the proprietary amino acid derivative
• Placebo first day
A non-active orally administered supplement of the proprietary amino acid derivative
• Amino acid supplement second day
An orally administered supplement of the proprietary amino acid derivative
• Placebo second day
A non-active orally administered supplement of the proprietary amino acid derivative

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change of Triiodthyronine Over Baseline	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.	0-120 minutes, at Baseline and post dose, week 1 and week 3