NCT01353014

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for early_phase_1 healthy

Timeline
Completed

Started May 2011

Typical duration for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

May 4, 2011

Last Update Submit

June 29, 2014

Conditions

Healthy

Keywords

NutrigenomicsDietNutrition

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    12 months

Study Arms (2)

Dietary advice with genetic information

EXPERIMENTAL

This group will receive dietary advice for caffeine, vitamin C, sugar and sodium based on genetic information.

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).

Other: General dietary recommendations

Interventions

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.

Dietary advice with genetic information
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.

General dietary recommendations

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year old participants from the Toronto Nutrigenomics and Health Study

You may not qualify if:

  • pregnancy or nursing
  • vitamin C supplement users
  • caffeine intake \< 100 mg/day
  • total sugars intake \< 10% energy
  • sodium intake \< 1500 mg/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25398084DERIVED

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Ahmed El-Sohemy, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 12, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

September 1, 2012

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

CA(1)