Aging, Growth Hormone Treatment
Conditions
Keywords
Somatostatin, Thyroid Hormone, Growth Hormone
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.
Interventions
DRUGAmino acid supplement first day
An orally administered supplement of the proprietary amino acid derivative
DRUGPlacebo first day
A non-active orally administered supplement of the proprietary amino acid derivative
DRUGAmino acid supplement second day
An orally administered supplement of the proprietary amino acid derivative
DRUGPlacebo second day
A non-active orally administered supplement of the proprietary amino acid derivative
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change of Triiodthyronine Over Baseline | 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. |
Participant flow
Recruitment details
Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.
Pre-assignment details
16 participants recruited; 16 Screened, 0 excluded (12 Males and 4 Females)
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Supplements with the proprietary amino acid derivative blend.
Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 23 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 16 | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: 0-120 minutes, at Baseline and post dose, week 1 and week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amino Acid Supplement | Percent Change of Triiodthyronine Over Baseline | -3.3 percent change | Standard Deviation 10.3 |
| Placebo | Percent Change of Triiodthyronine Over Baseline | -6.1 percent change | Standard Deviation 8.5 |