Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

• ClinicalTrials.gov Identifier: NCT02987868
• Recruitment Status: Completed
• First Posted: December 9, 2016
• Results First Posted: February 8, 2018
• Last Update Posted: February 8, 2018
• Sponsor: Pennington Biomedical Research Center
• Information provided by (Responsible Party): Frank Greenway, Pennington Biomedical Research Center

Tracking Information

• First Submitted Date: December 6, 2016
• First Posted Date: December 9, 2016
• Results First Submitted Date: October 3, 2017
• Results First Posted Date: February 8, 2018
• Last Update Posted Date: February 8, 2018
• Study Start Date: October 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 6, 2016)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine
• Official Title: Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Growth Hormone Treatment
• Aging

Intervention

• Drug: Amino acid supplement first day
  An orally administered supplement of the proprietary amino acid derivative
  Other Name: SeroVital™
• Drug: Placebo first day
  A non-active orally administered supplement of the proprietary amino acid derivative
  Other Name: Non-active
• Drug: Amino acid supplement second day
  An orally administered supplement of the proprietary amino acid derivative
  Other Name: SeroVital™
• Drug: Placebo second day
  A non-active orally administered supplement of the proprietary amino acid derivative
  Other Name: Non-active

Study Arms

• 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.
  Interventions:

  • Drug: Amino acid supplement first day
  • Drug: Placebo second day
• 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.
  Interventions:

  • Drug: Placebo first day
  • Drug: Amino acid supplement second day

• Publications *: 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. 2020 Oct 8. doi: 10.1089/jmf.2020.0109. [Epub ahead of print]

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 6, 2016): 16
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02987868
• Other Study ID Numbers: PBRC 10043 - HGH/Somatostatin
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Frank Greenway, Pennington Biomedical Research Center
• Study Sponsor: Pennington Biomedical Research Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Frank Greenway, M.D.; Pennington Biomedical Research Center

• PRS Account: Pennington Biomedical Research Center
• Verification Date: February 2018