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Completed

NCT Number: NCT01540773

Single Low-Dose of Supplement Amino Acid

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.

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Key information

Conditions

Growth Hormone Amino Acid

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amino acid supplement

Drug

An orally administered supplement of the proprietary amino acid derivative

Other names: SeroVital™

Placebo

Drug

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

Other names: non-active

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Feb 29, 2012
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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