Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

Not Applicable

Completed

• Conditions: Aging; Growth Hormone Treatment
• Interventions: Drug: Amino acid supplement first day; Drug: Placebo first day; Drug: Placebo second day; Drug: Amino acid supplement second day

• Registration Number: NCT02987868
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-09
• Results First Submitted: 2017-10-03
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-06
• Last Update Submitted: 2018-02-06
• Results First Posted: 2018-02-08
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplement 1st day, placebo 2nd day	Placebo second 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.
Supplement 1st day, placebo 2nd day	Amino acid supplement first 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.
Placebo 1st day, supplement 2nd day	Placebo first day	Half of the participants took the placebo first day and half of the participants took placebo second day.
Placebo 1st day, supplement 2nd day	Amino acid supplement second day	Half of the participants took the placebo first day and half of the participants took placebo second day.

Primary Outcome Measures

Name	Time	Method
Percent Change of Triiodthyronine Over Baseline	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.