Health BehaviorNCT02440698
Experiences With a Genetic Test for Personalized Nutrition Test for Personalized Nutrition
An observational study of Health Behavior, run by University of Toronto at 1 site in Canada.
Trial summary
The investigators will use a web-based survey to collect data on individual attitudes and self-reported health behaviour changes following genetic testing for personalized nutrition. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Genetic test for personalized nutrition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Aug 2015
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants (n=80) are employees of a large multi-national food company's R\&D division located in Australia, Switzerland, USA and the UK. They underwent a genetic test for personalized nutrition in March 2015 that was offered at no cost through the company wellness program.
Who may be able to join
- Completed a genetic test for personalized nutrition through company wellness program.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experiences With a Healthcare Professional-mediated Genetic Test for Personalized Nutrition
The investigators will use a web-based survey to collect data on individual attitudes and self-reported health behaviour changes following genetic testing for personalized nutrition. Participants (n=80) are employees of a large multi-national food company's R\&D division located in Australia, Switzerland, USA and the UK. They underwent a genetic test for personalized nutrition in March 2015 that was offered at no cost through the company wellness program. A registered dietitian completed a pre-test consultation and disclosed the test results with DNA-based dietary advice. The test provided information on 7 components of diet and additional information on individual risk for gluten intolerance.
- Conditions
- Health Behavior
- Being tested
- Genetic test for personalized nutrition
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic test for personalized nutritionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Health behaviour change
Do individuals self-report beneficial changes to their diets or lifestyle as a result of the DNA-based dietary advice?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrigenomix Inc.
- Responsible party
- Principal investigator, Ahmed El-Sohemy, University of Toronto
- Investigators
- Ahmed El-Sohemy, PhD, Principal investigator, University of TorontoDaiva Nielsen, PhD, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440698
- Sponsor's protocol ID
- 31523
- Status last verified
- May 2015
- First submitted
- 7 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences With a Healthcare Professional-mediated Genetic Test for Personalized Nutrition
- ClinicalTrials.gov ID
- NCT02440698
- Acronym / sponsor ID
- 31523
- Conditions
- Health Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Nutrigenomix Inc.
- Study start
- May 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 12 May 2015 (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 investigators will use a web-based survey to collect data on individual attitudes and self-reported health behaviour changes following genetic testing for personalized nutrition. Participants (n=80) are employees of a large multi-national food company's R\&D division located in Australia, Switzerland, USA and the UK. They underwent a genetic test for personalized nutrition in March 2015 that was offered at no cost through the company wellness program. A registered dietitian completed a pre-test consultation and disclosed the test results with DNA-based dietary advice. The test provided information on 7 components of diet and additional information on individual risk for gluten intolerance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants (n=80) are employees of a large multi-national food company's R\&D division located in Australia, Switzerland, USA and the UK. They underwent a genetic test for personalized nutrition in March 2015 that was offered at no cost through the company wellness program.
Key inclusion criteria (1 listed)
- Completed a genetic test for personalized nutrition through company wellness program.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Genetic test for personalized nutrition | Behavioural | – |
Primary outcome
Health behaviour change
Time frame: 3 months
Do individuals self-report beneficial changes to their diets or lifestyle as a result of the DNA-based dietary advice?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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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.
Ahmed El-Sohemy, PhD principal investigator
University of Toronto
Daiva Nielsen, PhD study director
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by University of Toronto 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 1 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: status not confirmed, as of the sponsor's last update on 12 May 2015. 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.
Are results available for this study?
Results are not available in the source record.
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?
Health behaviour change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2015.