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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amino acid supplement | Active Comparator | supplements with the proprietary amino acid derivative blend. |
|
| Placebo | Placebo Comparator | Non-Active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino acid supplement | Drug | An orally administered supplement of the proprietary amino acid derivative |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-120 minutes, at Baseline and post dose, week 1 and week 3 |
| 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. | 0-120 minutes, at Baseline and post dose, week 1 and week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 hours following administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Greenway, MD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30893070 | Derived | Tam CS, Johnson WD, Rood J, Heaton AL, Greenway FL. Increased Human Growth Hormone After Oral Consumption of an Amino Acid Supplement: Results of a Randomized, Placebo-Controlled, Double-Blind, Crossover Study in Healthy Subjects. Am J Ther. 2020 Jul/Aug;27(4):e333-e337. doi: 10.1097/MJT.0000000000000893. |
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16 participants recruited; 16 Screened, 0 excluded
Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Wash Out Period of 1 Week |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Crossover of amino acid supplement to placebo or placebo to amino acid supplement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | nanograms/ml | 0-120 minutes, at Baseline and post dose, week 1 and week 3 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amino Acid Supplement | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Greenway, Chief of Outpatient Clinic | Pennington Biomedical Research Center | 225-763-2578 | Frank.Greenway@pbrc.edu |
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| Placebo | Drug | A non-active orally administered supplement of the proprietary amino acid derivative |
|
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Placebo |
Non-Active Placebo: A non-active orally administered supplement of the proprietary amino acid derivative |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | min*ng/mL | 0-120 minutes, at Baseline and post dose, week 1 and week 3 |
|
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| 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 | Posted | Mean | Standard Deviation | ng/mL | 8 hours following administration |
|
|
|
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Placebo | Non-Active Placebo: A non-active orally administered supplement of the proprietary amino acid derivative | 0 | 16 | 1 | 16 |
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