Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

Conditions
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Growth Hormone Treatment, Aging

Intervention / Treatment
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* Drug: Amino acid supplement first day
* Drug: Placebo first day
* Drug: Amino acid supplement second day
* Drug: Placebo second day


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplement 1st day, placebo 2nd day<br>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. | Drug: Amino acid supplement first day<br>* An orally administered supplement of the proprietary amino acid derivative<br>* Other names: SeroVital™;Drug: Placebo second day<br>* A non-active orally administered supplement of the proprietary amino acid derivative<br>* Other names: Non-active;|
| Placebo Comparator: Placebo 1st day, supplement 2nd day<br>Half of the participants took the placebo first day and half of the participants took placebo second day. | Drug: Placebo first day<br>* A non-active orally administered supplement of the proprietary amino acid derivative<br>* Other names: Non-active;Drug: Amino acid supplement second day<br>* An orally administered supplement of the proprietary amino acid derivative<br>* Other names: SeroVital™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change of Triiodthyronine Over Baseline | 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. | 0-120 minutes, at Baseline and post dose, week 1 and week 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Somatostatin, Thyroid Hormone, Growth Hormone