Single Low-Dose of Supplement Amino Acid

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.

Conditions
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Growth Hormone, Amino Acid

Intervention / Treatment
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* Drug: Amino acid supplement
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: amino acid supplement<br>supplements with the proprietary amino acid derivative blend. | Drug: Amino acid supplement<br>* An orally administered supplement of the proprietary amino acid derivative<br>* Other names: SeroVital™;|
| Placebo Comparator: Placebo<br>Non-Active | Drug: Placebo<br>* A non-active orally administered supplement of the proprietary amino acid derivative<br>* Other names: non-active;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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growth hormone