Genetic Information and Dietary Intake Behaviour

June 29, 2014 updated by: Ahmed El-Sohemy, University of Toronto
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 3E2
        • University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20-35 year old participants from the Toronto Nutrigenomics and Health Study

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary advice with genetic information
This group will receive dietary advice for caffeine, vitamin C, sugar and sodium based on genetic information.
Other: Dietary advice with genetic information
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.
Active Comparator: General dietary recommendations
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
This group will receive general dietary recommendations from recognized health organizations for caffeine, vitamin C, sugar and sodium, with no genetic information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Advance Foods and Materials Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 29, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AElSohemy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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