Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

NCT02987868 | Completed Results

• 1 other identifier: PBRC 10043 - HGH/Somatostatin
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Growth Hormone Treatment; Aging

Keywords

Somatostatin; Thyroid Hormone; Growth Hormone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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

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.

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

Interventions

Amino acid supplement first day DRUG

An orally administered supplement of the proprietary amino acid derivative

Also known as: SeroVital™

Supplement 1st day, placebo 2nd day

Placebo first day DRUG

A non-active orally administered supplement of the proprietary amino acid derivative

Also known as: Non-active

Placebo 1st day, supplement 2nd day

Amino acid supplement second day DRUG

An orally administered supplement of the proprietary amino acid derivative

Also known as: SeroVital™

Placebo 1st day, supplement 2nd day

Placebo second day DRUG

A non-active orally administered supplement of the proprietary amino acid derivative

Also known as: Non-active

Supplement 1st day, placebo 2nd day

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy males and 4 healthy females
• Between 18 and 70 years

You may not qualify if:

• Pregnant or nursing
• Taking any chronic medication including birth control pills.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Related Publications (1)

• 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.

  PMID: 33030391 DERIVED

Results Point of Contact

• Title: Dr. Frank Greenway, Chief of Outpatient Clinic
• Organization: Pennington Biomedical Research Center

Frank.Greenway@pbrc.edu

225-763-2578

Study Officials

• Frank Greenway, M.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: February 8, 2018
• Results First Posted: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share