HealthyEarly Phase 1NCT01353014
Genetic Information and Dietary Intake Behaviour
A Early Phase 1 study testing Dietary advice with genetic information and General dietary recommendations in people with Healthy, run by University of Toronto at 1 site in Canada.
Trial summary
This study's primary objective is to determine if providing individuals with personal genetic information impacts dietary intake behaviour. Specifically, the investigators will be examining whether providing dietary advice based on genes that affect the metabolism of or sensitivity to caffeine, vitamin C, sugar and… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary advice with genetic information and General dietary recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Sep 2012
- Phase
- Early 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-35 year old participants from the Toronto Nutrigenomics and Health Study
Who cannot join
- pregnancy or nursing
- vitamin C supplement users
- caffeine intake < 100 mg/day
- total sugars intake < 10% energy
- sodium intake < 1500 mg/day
Trial locations and contacts
1 site in 1 country.
About this study
This study's primary objective is to determine if providing individuals with personal genetic information impacts dietary intake behaviour. Specifically, the investigators will be examining whether providing dietary advice based on genes that affect the metabolism of or sensitivity to caffeine, vitamin C, sugar and sodium will impact the intake of these dietary components. The study hypothesis is that providing dietary advice based on genetics will impact dietary behaviour to a greater extent than general dietary recommendations.
- Conditions
- Healthy
- Being tested
- Dietary advice with genetic information, General dietary recommendations
- Keywords
- Nutrigenomics, Diet, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary advice with genetic informationOther
This group will receive dietary advice for caffeine, vitamin C, sugar and sodium based on genes that affect the metabolism of or sensitivity to caffeine, vitamin C, sugar and sodium.
General dietary recommendationsOther
This group will receive general dietary recommendations from recognized health organizations for caffeine, vitamin C, sugar and sodium, with no genetic information.
| Study group | Role | What they receive |
|---|---|---|
| Dietary advice with genetic information | Experimental | This group will receive dietary advice for caffeine, vitamin C, sugar and sodium based on genetic information. Receives: Other: Dietary advice with genetic information |
| General dietary recommendations | Active comparator | This group will receive general dietary recommendations for caffeine, vitamin C, sugar and sodium from recognized health institutions (caffeine: Health Canada; sugar: the World Health Organization; vitamin C and sodium: the Institute of Medicine). Receives: Other: General dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Dietary Intake at 3 months
We will assess dietary intakes of caffeine (mg), vitamin C (mg), sugar (g and % energy) and sodium (mg) using Food Frequency Questionnaires (FFQ). An FFQ will be administered at baseline to determine dietary habits before dietary advice is given to either group (control or intervention). A second FFQ will be administered 3 months after the dietary advice is given, to examine if any changes were made to dietary intake in the short-term.
Measured: 3 months
Change from Baseline in Dietary Intake at 12 months
A third FFQ will be administered 12 months after the dietary advice is given, to examine if any long-term dietary changes were made in intakes of caffeine (mg), vitamin C (mg), sugar (g and % energy) and sodium (mg).
Measured: 12 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 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionSep 2012
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 HealthyStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Advance Foods and Materials Network
- Responsible party
- Principal investigator, Ahmed El-Sohemy, University of Toronto
- Investigators
- Ahmed El-Sohemy, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353014
- Sponsor's protocol ID
- AElSohemy
- Status last verified
- Jun 2014
- First submitted
- 4 May 2011
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen DE, El-Sohemy A. Disclosure of genetic information and change in dietary intake: a randomized controlled trial. PLoS One. 2014 Nov 14;9(11):e112665. doi: 10.1371/journal.pone.0112665. eCollection 2014.
PubMed 25398084
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Information and Dietary Intake Behaviour
- ClinicalTrials.gov ID
- NCT01353014
- Acronym / sponsor ID
- AElSohemy
- Conditions
- Healthy
- Keywords
- Nutrigenomics, Diet, Nutrition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Advance Foods and Materials Network
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 May 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.
This study's primary objective is to determine if providing individuals with personal genetic information impacts dietary intake behaviour. Specifically, the investigators will be examining whether providing dietary advice based on genes that affect the metabolism of or sensitivity to caffeine, vitamin C, sugar and sodium will impact the intake of these dietary components. The study hypothesis is that providing dietary advice based on genetics will impact dietary behaviour to a greater extent than general dietary recommendations.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary advice with genetic information | Experimental | Other: Dietary advice with genetic informationThis group will receive dietary advice for caffeine, vitamin C, sugar and sodium based on genetic information. |
| General dietary recommendations | Active comparator | Other: General dietary recommendationsThis group will receive general dietary recommendations for caffeine, vitamin C, sugar and sodium from recognized health institutions (caffeine: Health Canada; sugar: the World Health Organization; vitamin C and sodium: the Institute of Medicine). |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20-35 year old participants from the Toronto Nutrigenomics and Health Study
Key exclusion criteria (5 listed)
- pregnancy or nursing
- vitamin C supplement users
- caffeine intake < 100 mg/day
- total sugars intake < 10% energy
- sodium intake < 1500 mg/day
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 |
|---|---|---|
| Dietary advice with genetic informationThis group will receive dietary advice for caffeine, vitamin C, sugar and sodium based on genes that affect the metabolism of or sensitivity to caffeine, vitamin C, sugar and sodium. | Other | Dietary advice with genetic information |
| General dietary recommendationsThis group will receive general dietary recommendations from recognized health organizations for caffeine, vitamin C, sugar and sodium, with no genetic information. | Other | General dietary recommendations |
Primary outcome
Change from Baseline in Dietary Intake at 3 months
Time frame: 3 months
We will assess dietary intakes of caffeine (mg), vitamin C (mg), sugar (g and % energy) and sodium (mg) using Food Frequency Questionnaires (FFQ). An FFQ will be administered at baseline to determine dietary habits before dietary advice is given to either group (control or intervention). A second FFQ will be administered 3 months after the dietary advice is given, to examine if any changes were made to dietary intake in the short-term.
Change from Baseline in Dietary Intake at 12 months
Time frame: 12 months
A third FFQ will be administered 12 months after the dietary advice is given, to examine if any long-term dietary changes were made in intakes of caffeine (mg), vitamin C (mg), sugar (g and % energy) and sodium (mg).
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 1 Jul 2014.
- Derived from this study: PubMed 25398084Nielsen DE, El-Sohemy A. Disclosure of genetic information and change in dietary intake: a randomized controlled trial. PLoS One. 2014 Nov 14;9(11):e112665. doi: 10.1371/journal.pone.0112665. eCollection 2014.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dietary advice with genetic information and General dietary recommendations in people with Healthy, 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 5 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 1 Jul 2014. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change from Baseline in Dietary Intake at 3 months (time frame: 3 months). 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 NCT01353014, 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 1 Jul 2014.