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Trial Outcomes & Findings for Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine (NCT NCT02987868)

NCT ID: NCT02987868

Last Updated: 2018-02-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

0-120 minutes, at Baseline and post dose, week 1 and week 3

Results posted on

2018-02-08

Participant Flow

Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.

16 participants recruited; 16 Screened, 0 excluded (12 Males and 4 Females)

Participant milestones

Participant milestones
Measure
Amino Acid Supplement First, Then Placebo
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.
Placebo First, Then Amino Acid Supplement
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.
First Intervention
STARTED
8
8
First Intervention
COMPLETED
8
8
First Intervention
NOT COMPLETED
0
0
Wash Out Period 1 Week
STARTED
8
8
Wash Out Period 1 Week
COMPLETED
8
8
Wash Out Period 1 Week
NOT COMPLETED
0
0
Second Intervention
STARTED
8
8
Second Intervention
COMPLETED
8
8
Second Intervention
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=16 Participants
Supplements with the proprietary amino acid derivative blend. Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
23 years
STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=5 Participants
Race (NIH/OMB)
White
9 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
16 participants
n=5 Participants

PRIMARY outcome

Timeframe: 0-120 minutes, at Baseline and post dose, week 1 and week 3

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.

Outcome measures

Outcome measures
Measure
Amino Acid Supplement
n=16 Participants
Supplements with the proprietary amino acid derivative blend. Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative
Placebo
n=16 Participants
Non-active Placebo: A non-active orally administered supplement of the proprietary amino acid derivative
Percent Change of Triiodthyronine Over Baseline
-3.3 percent change
Standard Deviation 10.3
-6.1 percent change
Standard Deviation 8.5

Adverse Events

Amino Acid Supplement

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Amino Acid Supplement
n=16 participants at risk
Supplements with the proprietary amino acid derivative blend. Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative
Placebo
n=16 participants at risk
Non-active Placebo: A non-active orally administered supplement of the proprietary amino acid derivative
Gastrointestinal disorders
Nausea
6.2%
1/16 • Number of events 1
6.2%
1/16 • Number of events 1

Additional Information

Dr. Frank Greenway, Chief of Outpatient Clinic

Pennington Biomedical Research Center

Phone: 225-763-2578

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place