Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

NCT ID: NCT02987868

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Growth Hormone Treatment; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Supplement 1st day, placebo 2nd 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.

Group Type: ACTIVE_COMPARATOR

Amino acid supplement first day

Intervention Type: DRUG

An orally administered supplement of the proprietary amino acid derivative

Placebo second day

Intervention Type: DRUG

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

Placebo 1st day, supplement 2nd day

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

Group Type: PLACEBO_COMPARATOR

Placebo first day

Intervention Type: DRUG

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

Amino acid supplement second day

Intervention Type: DRUG

An orally administered supplement of the proprietary amino acid derivative

Interventions

Amino acid supplement first day

An orally administered supplement of the proprietary amino acid derivative

Intervention Type: DRUG

Placebo first day

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

Intervention Type: DRUG

Amino acid supplement second day

An orally administered supplement of the proprietary amino acid derivative

Intervention Type: DRUG

Placebo second day

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

Intervention Type: DRUG

Other Intervention Names

SeroVital™; Non-active; SeroVital™; Non-active

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Frank Greenway

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Greenway, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

References

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.

Reference Type: DERIVED

PMID: 33030391 (View on PubMed)

Other Identifiers

PBRC 10043 - HGH/Somatostatin

Identifier Type: -

Identifier Source: org_study_id