Trial Outcomes & Findings for Single Low-Dose of Supplement Amino Acid (NCT NCT01540773)

Last Updated: 2018-10-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

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

Results posted on

2018-10-22

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

Participant milestones

Participant milestones
Measure	Amino Acid Supplement, Then Placebo 50% of participants first received an orally administered supplement with the proprietary amino acid derivative blend. After a washout period of one week, they then received a Placebo tablet (matching the amino acid supplement).	Placebo, Then Amino Acid Supplement 50% of participants first received an orally administered Placebo tablet (matching the amino acid supplement). After a washout period of one week, they then received the orally administered supplement 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 of 1 Week STARTED	8	8
Wash Out Period of 1 Week COMPLETED	8	8
Wash Out Period of 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

Single Low-Dose of Supplement Amino Acid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=16 Participants Crossover of amino acid supplement to placebo or placebo to amino acid supplement
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

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 A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined.	Placebo n=16 Participants Non-Active Placebo: A non-active orally administered supplement of the proprietary amino acid derivative
Change From Baseline of Growth Hormone	1.15 nanograms/ml Interval 0.17 to 2.14	-0.48 nanograms/ml Interval -1.47 to 0.5

PRIMARY outcome

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

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 A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined.	Placebo n=16 Participants Non-Active Placebo: A non-active orally administered supplement of the proprietary amino acid derivative
Area Under the Curve of Growth Hormone Over Baseline	20.43 min*ng/mL Interval 19.9 to 20.95	19.67 min*ng/mL Interval 18.74 to 20.59

SECONDARY outcome

Timeframe: 8 hours following administration

Measure IGF-1 8 hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebo

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 A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined.	Placebo n=16 Participants Non-Active Placebo: A non-active orally administered supplement of the proprietary amino acid derivative
Insulin-like Growth Factor 1	208.125 ng/mL Standard Deviation 55.769	224.375 ng/mL Standard Deviation 67.903

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place