Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

• 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: Pennington Biomedical Research Center
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		All Study Participants
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
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

Outcome Measures

1. Primary Outcome

Title	Percent Change of Triiodthyronine Over Baseline
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amino Acid Supplement	Placebo
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Amino Acid Supplement		Placebo
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	--/--		--/--
Serious Adverse Events
	Amino Acid Supplement		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0.00%)		0/16 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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

• 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