Clinical trial NCT02987868: Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine
Official title: Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Hormone Treatment
Aging
Keywords: Somatostatin
Thyroid Hormone
Growth Hormone
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percent Change of Triiodthyronine Over Baseline
timeFrame: 0-120 minutes, at Baseline and post dose, week 1 and week 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank Greenway, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heaton AL, Kelly C, Rood J, Tam CS, Greenway FL. Mechanism for the Increase in Human Growth Hormone with Administration of a Novel Test Supplement and Results Indicating Improved Physical Fitness and Sleep Efficiency. J Med Food. 2021 Jun;24(6):653-659. doi: 10.1089/jmf.2020.0109. Epub 2020 Oct 8.