Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine
February 6, 2018 updated by: Frank Greenway, Pennington Biomedical Research Center
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
An orally administered supplement of the proprietary amino acid derivative
Other Names:
A non-active orally administered supplement of the proprietary amino acid derivative
Other Names:
|
|
Placebo Comparator: Placebo 1st day, supplement 2nd day
Half of the participants took the placebo first day and half of the participants took placebo second day.
|
A non-active orally administered supplement of the proprietary amino acid derivative
Other Names:
An orally administered supplement of the proprietary amino acid derivative
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Change of Triiodthyronine Over Baseline
Time Frame: 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.
|
0-120 minutes, at Baseline and post dose, week 1 and week 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frank Greenway, M.D., Pennington Biomedical Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
December 6, 2016
First Submitted That Met QC Criteria
December 6, 2016
First Posted (Estimate)
December 9, 2016
Study Record Updates
Last Update Posted (Actual)
February 8, 2018
Last Update Submitted That Met QC Criteria
February 6, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PBRC 10043 - HGH/Somatostatin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.