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Completed

NCT Number: NCT02987868

Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amino acid supplement first day

Drug

An orally administered supplement of the proprietary amino acid derivative

Other names: SeroVital™

Placebo first day

Drug

A non-active orally administered supplement of the proprietary amino acid derivative

Other names: Non-active

Amino acid supplement second day

Drug

An orally administered supplement of the proprietary amino acid derivative

Other names: SeroVital™

Placebo second day

Drug

A non-active orally administered supplement of the proprietary amino acid derivative

Other names: Non-active

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Dec 9, 2016
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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