Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine
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ClinicalTrials.gov Identifier: NCT02987868 |
Recruitment Status :
Completed
First Posted : December 9, 2016
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
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Study Type | Interventional |
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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 |
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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 | |
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Supplements with the proprietary amino acid derivative blend. Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative |
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Overall Number of Baseline Participants | 16 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 16 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
16 100.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 16 participants | |
23 (14) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 16 participants | |
Female |
4 25.0%
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Male |
12 75.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 16 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
6 37.5%
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White |
9 56.3%
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More than one race |
1 6.3%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 16 participants |
16 |
Name/Title: | Dr. Frank Greenway, Chief of Outpatient Clinic |
Organization: | Pennington Biomedical Research Center |
Phone: | 225-763-2578 |
EMail: | Frank.Greenway@pbrc.edu |
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 |