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Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Growth Hormone Treatment
Aging
Interventions Drug: Amino acid supplement first day
Drug: Placebo first day
Drug: Amino acid supplement second day
Drug: Placebo second day
Enrollment 16
Recruitment Details Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.
Pre-assignment Details 16 participants recruited; 16 Screened, 0 excluded (12 Males and 4 Females)
Arm/Group Title Amino Acid Supplement First, Then Placebo Placebo First, Then Amino Acid Supplement
Hide Arm/Group Description

An orally administered amino acid supplement first, and after washout period, placebo.

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

Amino acid supplement: Supplements with the proprietary amino acid derivative blend.

Non-active Placebo first, and after washout period, an orally administered amino acid supplement.

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

Amino acid supplement: Supplements with the proprietary amino acid derivative blend.

Period Title: First Intervention
Started 8 8
Completed 8 8
Not Completed 0 0
Period Title: Wash Out Period 1 Week
Started 8 8
Completed 8 8
Not Completed 0 0
Period Title: Second Intervention
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

Supplements with the proprietary amino acid derivative blend.

Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
23  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
4
  25.0%
Male
12
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  37.5%
White
9
  56.3%
More than one race
1
   6.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Percent Change of Triiodthyronine Over Baseline
Hide Description 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.
Time Frame 0-120 minutes, at Baseline and post dose, week 1 and week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amino Acid Supplement Placebo
Hide Arm/Group Description:

Supplements with the proprietary amino acid derivative blend.

Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative

Non-active

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

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: percent change
-3.3  (10.3) -6.1  (8.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amino Acid Supplement Placebo
Hide Arm/Group Description

Supplements with the proprietary amino acid derivative blend.

Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative

Non-active

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

All-Cause Mortality
Amino Acid Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Amino Acid Supplement Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amino Acid Supplement Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      1/16 (6.25%)    
Gastrointestinal disorders     
Nausea   1/16 (6.25%)  1 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Frank Greenway, Chief of Outpatient Clinic
Organization: Pennington Biomedical Research Center
Phone: 225-763-2578
EMail: Frank.Greenway@pbrc.edu
Layout table for additonal information
Responsible Party: Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02987868    
Other Study ID Numbers: PBRC 10043 - HGH/Somatostatin
First Submitted: December 6, 2016
First Posted: December 9, 2016
Results First Submitted: October 3, 2017
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018