Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

Pennington Biomedical Research Center

Status: Completed

Conditions: Aging; Growth Hormone Treatment

Treatments: Drug: Placebo first day; Drug: Amino acid supplement first day; Drug: Placebo second day; Drug: Amino acid supplement second day

Study type: Interventional

Funder types: Other

Identifiers

NCT02987868

PBRC 10043 - HGH/Somatostatin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

Supplement 1st day, placebo 2nd day

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo second day

Drug: Amino acid supplement first day

Placebo 1st day, supplement 2nd day

Placebo Comparator group

Description:

Half of the participants took the placebo first day and half of the participants took placebo second day.

Treatment:

Drug: Amino acid supplement second day

Drug: Placebo first day