Growth HormoneNCT01540773
Single Low-Dose of Supplement Amino Acid
A study testing Amino acid supplement in people with Growth Hormone and Amino Acid, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Growth Hormone, Amino Acid
- What is being tested?
- Amino acid supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthy males and healthy females
- Between 18 and 70 years
Who cannot join
- Pregnant or nursing
- Taking any chronic medication including birth control pills.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.
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.
Read the 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.
- Conditions
- Growth Hormone, Amino Acid
- Being tested
- Amino acid supplement, Placebo
- Keywords
- growth hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid supplementDrug
Also called SeroVital™
An orally administered supplement of the proprietary amino acid derivative
PlaceboDrug
Also called non-active
A non-active orally administered supplement of the proprietary amino acid derivative
| Study group | Role | What they receive |
|---|---|---|
| amino acid supplement | Active comparator | supplements with the proprietary amino acid derivative blend. Receives: Drug: Amino acid supplement |
| Placebo | Placebo comparator | Non-Active Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0-120 minutes, at Baseline and post dose, week 1 and week 3
Secondary outcomes (1)
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
Measured: 8 hours following administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth HormoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank Greenway, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540773
- Sponsor's protocol ID
- PBRC 10043
- Status last verified
- Oct 2018
- First submitted
- 23 Feb 2012
- Last updated
- 22 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30893070
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01540773
- Acronym / sponsor ID
- PBRC 10043
- Conditions
- Growth Hormone, Amino Acid
- Keywords
- growth hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Feb 2012 (estimated)
- Results
- Posted 21 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amino acid supplement | Active comparator | Drug: Amino acid supplementsupplements with the proprietary amino acid derivative blend. |
| Placebo | Placebo comparator | Drug: PlaceboNon-Active |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy males and healthy females
- Between 18 and 70 years
Key exclusion criteria (2 listed)
- Pregnant or nursing
- Taking any chronic medication including birth control pills.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino acid supplementAlso: SeroVital™An orally administered supplement of the proprietary amino acid derivative | Drug | amino acid supplement |
| PlaceboAlso: non-activeA non-active orally administered supplement of the proprietary amino acid derivative | Drug | Placebo |
Primary outcome
Change From Baseline of Growth Hormone
Time frame: 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
Time frame: 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.
1 secondary outcome
Insulin-like Growth Factor 1
Time frame: 8 hours following administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30893070Tam 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Greenway, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acid supplement in people with Growth Hormone and Amino Acid, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline of Growth Hormone (time frame: 0-120 minutes, at Baseline and post dose, week 1 and week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01540773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.