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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement 1st day, placebo 2nd day | Active Comparator | 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. |
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| Placebo 1st day, supplement 2nd day | Placebo Comparator | Half of the participants took the placebo first day and half of the participants took placebo second day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino acid supplement first day | Drug | An orally administered supplement of the proprietary amino acid derivative |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Greenway, M.D. | Pennington Biomedical Research Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33030391 | Derived | 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. |
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16 participants recruited; 16 Screened, 0 excluded (12 Males and 4 Females)
Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amino Acid Supplement First, Then Placebo | An orally administered amino acid supplement first, and after washout period, placebo. Placebo: A non-active orally administered supplement of the proprietary amino acid derivative Amino acid supplement: Supplements with the proprietary amino acid derivative blend. |
| FG001 | Placebo First, Then Amino Acid Supplement | Non-active Placebo first, and after washout period, an orally administered amino acid supplement. Placebo: A non-active orally administered supplement of the proprietary amino acid derivative Amino acid supplement: Supplements with the proprietary amino acid derivative blend. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Wash Out Period 1 Week |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Supplements with the proprietary amino acid derivative blend. Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change | 0-120 minutes, at Baseline and post dose, week 1 and week 3 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amino Acid Supplement | Supplements with the proprietary amino acid derivative blend. Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Greenway, Chief of Outpatient Clinic | Pennington Biomedical Research Center | 225-763-2578 | Frank.Greenway@pbrc.edu |
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| Placebo first day | Drug | A non-active orally administered supplement of the proprietary amino acid derivative |
|
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| Amino acid supplement second day | Drug | An orally administered supplement of the proprietary amino acid derivative |
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| Placebo second day | Drug | A non-active orally administered supplement of the proprietary amino acid derivative |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Placebo | Non-active Placebo: A non-active orally administered supplement of the proprietary amino acid derivative | 0 | 16 | 1 | 16 |
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