NCT01540773

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

March 21, 2017

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

February 23, 2012

Results QC Date

November 14, 2014

Last Update Submit

October 18, 2018

Conditions

Growth HormoneAmino Acid

Keywords

growth hormone

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline of Growth Hormone

    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

    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 Outcomes (1)

  • Insulin-like Growth Factor 1

    8 hours following administration

Study Arms (2)

amino acid supplement

ACTIVE COMPARATOR

supplements with the proprietary amino acid derivative blend.

Drug: Amino acid supplement

Placebo

PLACEBO COMPARATOR

Non-Active

Drug: Placebo

Interventions

Amino acid supplementDRUG

An orally administered supplement of the proprietary amino acid derivative

Also known as: SeroVitalâ„¢
amino acid supplement
PlaceboDRUG

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

Also known as: non-active
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Tam CS, Johnson WD, Rood J, Heaton AL, Greenway FL. Increased Human Growth Hormone After Oral Consumption of an Amino Acid Supplement: Results of a Randomized, Placebo-Controlled, Double-Blind, Crossover Study in Healthy Subjects. Am J Ther. 2020 Jul/Aug;27(4):e333-e337. doi: 10.1097/MJT.0000000000000893.

    PMID: 30893070DERIVED

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, MD

    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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 29, 2012

Study Start

October 1, 2011

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

October 22, 2018

Results First Posted

March 21, 2017

Record last verified: 2018-10

Locations

US(1)