Healthy AdultsPhase 1NCT01474226
Metabolic Availability of Lysine From Rice
A Phase 1 study testing Amino Acid Crystalline Lysine Amino Acid Mix and Cooked Rice containing Lysine in people with Healthy Adults, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the digestibility of the amino acid lysine in cooked rice in adult men using stable isotope technique. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Amino Acid Crystalline Lysine Amino Acid Mix and Cooked Rice containing Lysine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Adult males (18 to 50years old)
Who cannot join
- A history of recent weight loss or illness
- Use of any medication at the time of entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Cooked Rice Protein in Adult Men
The purpose of this study is to investigate the digestibility of the amino acid lysine in cooked rice in adult men using stable isotope technique.
Read the detailed description
The investigators objective is to determine the metabolic availability (MA) of lysine in cooked white rice protein using the indicator amino acid oxidation (IAAO) technique. Five men will receive graded levels (20, 40, and 60, and 70%) of the lysine requirement of 35 mg/kg/d as a crystalline AA mixture,and cooked rice protein (20, 40 and 60%), respectively.
- Conditions
- Healthy Adults
- Being tested
- Amino Acid Crystalline Lysine Amino Acid Mix, Cooked Rice containing Lysine
- Keywords
- lysine, rice, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid Crystalline Lysine Amino Acid MixDietary supplement
crystalline lysine from AA MIX (20, 40, and 60% of the mean lysine requirement of 35 mg/kg/d) Lysine will be given in the form of L-Lysine-HCl, Sigma-Aldrich Brand.
Cooked Rice containing LysineDietary supplement
Lysine (20,40 and 60 % of the mean lysine requirement) from Cooked Rice
| Study group | Role | What they receive |
|---|---|---|
| Lysine Amino Acid | Experimental | Not described Receives: Dietary Supplement: Amino Acid Crystalline Lysine Amino Acid Mix; Dietary Supplement: Cooked Rice containing Lysine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Availability of lysine
3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.
Measured: Baseline
Metabolic Availability of lysine
3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.
Measured: 15 min after intake of the fourth hourly meal (before tracer infusion))
Metabolic Availability of lysine
3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.
Measured: 30 min after intake of the fourth hourly meal (before tracer infusion))
Metabolic Availability of lysine
3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.
Measured: 45 min after intake of the fourth hourly meal (before tracer infusion))
Secondary outcomes (1)
Metabolic Availability of Lysine
4 breath samples will be taken to provide F13CO2 measurement (Level of phenylalanine oxidation).Breath samples will be collected and analyzed for 13CO2 enrichment.
Measured: Post Tracer Infusion (between 150 and 240 min of tracer infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Pencharz, The Hospital for Sick Children
- Investigators
- Paul B Pencharz, MD, PhD, Principal investigator, The Hospital for Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474226
- Sponsor's protocol ID
- 0019850580
- Other IDs
- CIHR, grant MT10321
- Status last verified
- Jul 2013
- First submitted
- 10 Nov 2011
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Prolla IR, Rafii M, Courtney-Martin G, Elango R, da Silva LP, Ball RO, Pencharz PB. Lysine from cooked white rice consumed by healthy young men is highly metabolically available when assessed using the indicator amino acid oxidation technique. J Nutr. 2013 Mar;143(3):302-6. doi: 10.3945/jn.112.166728. Epub 2013 Jan 16.
PubMed 23325920
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Cooked Rice Protein in Adult Men
- ClinicalTrials.gov ID
- NCT01474226
- Acronym / sponsor ID
- 0019850580
- Conditions
- Healthy Adults
- Keywords
- lysine, rice, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
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 this study is to investigate the digestibility of the amino acid lysine in cooked rice in adult men using stable isotope technique.
Detailed description
The investigators objective is to determine the metabolic availability (MA) of lysine in cooked white rice protein using the indicator amino acid oxidation (IAAO) technique. Five men will receive graded levels (20, 40, and 60, and 70%) of the lysine requirement of 35 mg/kg/d as a crystalline AA mixture,and cooked rice protein (20, 40 and 60%), respectively.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lysine Amino Acid | Experimental | Dietary Supplement: Amino Acid Crystalline Lysine Amino Acid Mix, Dietary Supplement: Cooked Rice containing Lysine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Adult males (18 to 50years old)
Key exclusion criteria (2 listed)
- A history of recent weight loss or illness
- Use of any medication at the time of entry into the study.
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 Crystalline Lysine Amino Acid Mixcrystalline lysine from AA MIX (20, 40, and 60% of the mean lysine requirement of 35 mg/kg/d) Lysine will be given in the form of L-Lysine-HCl, Sigma-Aldrich Brand. | Dietary supplement | Lysine Amino Acid |
| Cooked Rice containing LysineLysine (20,40 and 60 % of the mean lysine requirement) from Cooked Rice | Dietary supplement | Lysine Amino Acid |
Primary outcome
Metabolic Availability of lysine
Time frame: Baseline
3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.
Metabolic Availability of lysine
Time frame: 15 min after intake of the fourth hourly meal (before tracer infusion))
3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.
Metabolic Availability of lysine
Time frame: 30 min after intake of the fourth hourly meal (before tracer infusion))
3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.
Metabolic Availability of lysine
Time frame: 45 min after intake of the fourth hourly meal (before tracer infusion))
3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.
1 secondary outcome
Metabolic Availability of Lysine
Time frame: Post Tracer Infusion (between 150 and 240 min of tracer infusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
- Derived from this study: PubMed 23325920Prolla IR, Rafii M, Courtney-Martin G, Elango R, da Silva LP, Ball RO, Pencharz PB. Lysine from cooked white rice consumed by healthy young men is highly metabolically available when assessed using the indicator amino acid oxidation technique. J Nutr. 2013 Mar;143(3):302-6. doi: 10.3945/jn.112.166728. Epub 2013 Jan 16.
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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.
Paul B Pencharz, MD, PhD principal investigator
The Hospital for Sick Children, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amino Acid Crystalline Lysine Amino Acid Mix and Cooked Rice containing Lysine in people with Healthy Adults, run by The Hospital for Sick Children at 1 site in Canada.
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 1 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 29 Jul 2013. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Metabolic Availability of lysine (time frame: Baseline). The study lists 4 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 NCT01474226, 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 29 Jul 2013.