Amino Acid, Growth Hormone
Conditions
Keywords
growth hormone
Brief summary
The purpose of the study is to confirm the results of a prior study that demonstrated pills containing two amino acids which are in foods increased growth hormone and insulin-like growth factor-1.
Detailed description
Oral supplementation with a key combination of derivatives that has been shown to increase human growth hormone in healthy volunteers peaking at 90 minutes and IGF-1 at 8 hours post-administration.
Interventions
An orally administered supplement of the proprietary amino acid derivative
DRUGPlacebo
A non-active orally administered supplement of the proprietary amino acid derivative
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* healthy males and healthy females * Between 18 and 70 years
Exclusion criteria
* Pregnant or nursing * Taking any chronic medication including birth control pills.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Growth Hormone | 0-120 minutes, at Baseline and post dose, week 1 and week 3 | 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. |
| Area Under the Curve of Growth Hormone Over Baseline | 0-120 minutes, at Baseline and post dose, week 1 and week 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin-like Growth Factor 1 | 8 hours following administration | Measure IGF-1 8 hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebo |
Countries
United States
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
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Crossover of amino acid supplement to placebo or placebo to amino acid supplement | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 23 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 16 | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Area Under the Curve of Growth Hormone Over Baseline
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.
Time frame: 0-120 minutes, at Baseline and post dose, week 1 and week 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Amino Acid Supplement | Area Under the Curve of Growth Hormone Over Baseline | 20.43 min*ng/mL |
| Placebo | Area Under the Curve of Growth Hormone Over Baseline | 19.67 min*ng/mL |
p-value: 0.04t-test, 2 sided
Primary
Change From Baseline of Growth Hormone
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.
Time frame: 0-120 minutes, at Baseline and post dose, week 1 and week 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Amino Acid Supplement | Change From Baseline of Growth Hormone | 1.15 nanograms/ml |
| Placebo | Change From Baseline of Growth Hormone | -0.48 nanograms/ml |
p-value: 0.01t-test, 2 sided
Secondary
Insulin-like Growth Factor 1
Measure IGF-1 8 hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebo
Time frame: 8 hours following administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amino Acid Supplement | Insulin-like Growth Factor 1 | 208.125 ng/mL | Standard Deviation 55.769 |
| Placebo | Insulin-like Growth Factor 1 | 224.375 ng/mL | Standard Deviation 67.903 |