An interventional study of Amino acid supplement first day and Placebo first day in Growth Hormone Treatment and Aging, sponsored by Pennington Biomedical Research Center. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-08.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Treatment
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.
Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Placebo second day
Half of the participants took the placebo first day and half of the participants took placebo second day.
Drug: Placebo first day · Drug: Amino acid supplement second day
An orally administered supplement of the proprietary amino acid derivative
Also known as: SeroVital™
A non-active orally administered supplement of the proprietary amino acid derivative
Also known as: Non-active
An orally administered supplement of the proprietary amino acid derivative
Also known as: SeroVital™
A non-active orally administered supplement of the proprietary amino acid derivative
Also known as: Non-active
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.
Time frame: 0-120 minutes, at Baseline and post dose, week 1 and week 3
Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.
| Milestone | Amino Acid Supplement First, Then Placebo | Placebo First, Then Amino Acid Supplement |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | Amino Acid Supplement First, Then Placebo | Placebo First, Then Amino Acid Supplement |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | Amino Acid Supplement First, Then Placebo | Placebo First, Then Amino Acid Supplement |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
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.
| percent change | Amino Acid Supplement | Placebo |
|---|---|---|
| Percent Change of Triiodthyronine Over Baseline | -3.3 ± 10.3 | -6.1 ± 8.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amino Acid Supplement | — | 0/16 (0%) | 1/16 (6.3%) |
| Placebo | — | 0/16 (0%) | 1/16 (6.3%) |
| Event | Amino Acid Supplement | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 1/16 | 1/16 |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 23 ± 14 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 4 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 9 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 16 |
No study locations are listed for this record.
Plan to share: No
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Pennington Biomedical Research Center