Genetic Information and Dietary Intake Behaviour

This study has been completed.
Sponsor:
Collaborator:
Advance Foods and Materials Network
Information provided by (Responsible Party):
Ahmed El-Sohemy, University of Toronto
ClinicalTrials.gov Identifier:
NCT01353014
First received: May 4, 2011
Last updated: June 29, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Other: Dietary advice with genetic information
Other: General dietary recommendations
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Genetic Information and Dietary Intake Behaviour

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Change from Baseline in Dietary Intake at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 138
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353014

Locations
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5S 3E2
Sponsors and Collaborators
University of Toronto
Advance Foods and Materials Network
Investigators
Principal Investigator: Ahmed El-Sohemy, PhD University of Toronto
  More Information

No publications provided

Responsible Party: Ahmed El-Sohemy, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01353014     History of Changes
Other Study ID Numbers: AElSohemy
Study First Received: May 4, 2011
Last Updated: June 29, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Nutrigenomics
Diet
Nutrition

ClinicalTrials.gov processed this record on July 26, 2014