Single Low-Dose of Supplement Amino Acid

October 18, 2018 updated by: Frank Greenway, Pennington Biomedical Research Center

Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.

The purpose of the study is to confirm the results of a prior study that demonstrated pills containing two amino acids which are in foods increased growth hormone and insulin-like growth factor-1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oral supplementation with a key combination of derivatives that has been shown to increase human growth hormone in healthy volunteers peaking at 90 minutes and IGF-1 at 8 hours post-administration.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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:

  • healthy males and 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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: amino acid supplement
supplements with the proprietary amino acid derivative blend.
Drug: Amino acid supplement
An orally administered supplement of the proprietary amino acid derivative
Other Names:
  • SeroVital™
Placebo Comparator: Placebo
Non-Active
Drug: Placebo
A non-active orally administered supplement of the proprietary amino acid derivative
Other Names:
  • non-active

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline of Growth Hormone
Time Frame: 0-120 minutes, at Baseline and post dose, week 1 and week 3
Measure human growth hormone 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
Area Under the Curve of Growth Hormone Over Baseline
Time Frame: 0-120 minutes, at Baseline and post dose, week 1 and week 3
Measure human growth hormone 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin-like Growth Factor 1
Time Frame: 8 hours following administration
Measure IGF-1 8 hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebo
8 hours following administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Frank Greenway, MD, 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.

General Publications

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)

March 1, 2012

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (Estimate)

February 29, 2012

Study Record Updates

Last Update Posted (Actual)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PBRC 10043

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.

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