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Strategies for Personalised Nutrition (Food4Me)

This study is currently recruiting participants.
Verified April 2013 by Newcastle University
Sponsor:
Collaborators:
University College Dublin
Maastricht University
University of Oslo
University of Navarra
Harokopio University
University of Reading
National Food and Nutrition InstitutE
Technische Universität München
University of Newcastle Upon-Tyne
Information provided by (Responsible Party):
Newcastle University
ClinicalTrials.gov Identifier:
NCT01530139
First received: February 1, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes

February 1, 2012
April 29, 2013
August 2012
December 2014   (final data collection date for primary outcome measure)
Changes from baseline in Dietary Intake at 3 and 6 months [ Time Frame: Baseline, month 3 and 6. ] [ Designated as safety issue: No ]
Habitual (usual) dietary intake will be measured using an on-line Food Frequency Questionnaire (FFQ). Intakes of nutrients will be computed using a food composition data base which has been augmented with country-specific food composition data. Changes in dietary pattern will be compared between baseline and month 3 and 6 in all participants.
Changes from baseline in Dietary Intake at 3 and 6 months [ Time Frame: Baseline, month 3 and 6. ] [ Designated as safety issue: No ]
Habitual (usual) dietary intake will be measured using an on-line version of the EPIC Food Frequency Questionnaire (FFQ). Intakes of nutrients will be computed using a food composition data base which has been augmented with country-specific food composition data. Changes in dietary pattern will be compared between baseline and month 3 and 6 in all participants.
Complete list of historical versions of study NCT01530139 on ClinicalTrials.gov Archive Site
Change from baseline in phenotypic and Metabolic biomarkers at 3 and 6 month [ Time Frame: baseline, month 3 and 6 ] [ Designated as safety issue: No ]
Obesity-related phenotypes (Weight [kg], BMI [kg/m^2], waits circumference [cm]Changes in glucose [mg/dl]),and metabolic-related markers (glucose [mg/dl], fatty acid [%]and total cholesterol [mg/dl]), will be measured at baseline, month 3 and 6.
Same as current
Not Provided
Not Provided
 
Strategies for Personalised Nutrition
Personalised Nutrition: An Integrative Analysis of Opportunities and Challenges

The concept of personalised nutrition emerged following the sequencing of the human genome in 2000. It was hoped that with the identification of gene nutrient interactions, an individual's response and susceptibility to particular diets would be better understood and therefore appropriate dietary modifications could be made to optimise health and lower disease risk. Then Food4Me aims to study the development of personalized nutrition at three levels and determine whether providing more personalised dietary advice leads to better compliance and health outcomes compared to standard population advice.

The hypotheses to be tested in the Food4Me study are as follows:

  • Personalisation of dietary advice assists and/or motivates consumers to eat a healthier diet and follow a healthier lifestyle (in comparison with "impersonal" [conventional] dietary advice).
  • Personalisation based on individualised biochemical (phenotypic) and/or genetic information is more effective in assisting and/or motivating study participants to make, and to sustain, appropriate healthy changes to their usual (habitual) diet and lifestyle.

To achieve the Food4me aims, investigators will undertake a large multi-centre proof-of-principle study carried out across 7 EU countries on options for the delivery of personalised nutrition.

Recruitment Centres

Recruitment to the Food4Me intervention study will be carried out using identical protocols in 7 centres across the EU involving a total of 1,288 study participants i.e. 184 participants per country. The Proof-of-Proof of Principle study centres involve in the recruitment are:

  • University College Dublin, Ireland.
  • University of Maastricht, Netherlands.
  • Universidad de Navarra, Spain.
  • Harokopio University, Greece.
  • The University of Reading, Uk
  • National Food and Nutrition Institute, Poland.
  • Technische Universitaet Muenchen, German.

Study design

Then, each proof-of-principle centre will recruit a sample of 184 participants and with 46 subjects will be randomly assigned each of the following levels of personalised nutrition:

  • Level 0: Control group - will receive non-personalized dietary advice for improved food choice based on standard population healthy eating guidelines.
  • Level 1: Personalised dietary advice based on dietary intake data alone.
  • Level 2: Personalised dietary advice taking dietary intake and phenotypic data into account.
  • Level 3: Personalised dietary advice taking dietary intake, phenotypic and genotypic data into account.

The study has been designed to mimic a fully Internet delivered personalized nutrition service. The route to recruitment will be via the Internet to mimic the real life conditions for a "proof-of-principle" study. However, to ensure adequate recruitment to this scientific study, the recruitment of study participants will be also based on local and national advertising of the service through internet, radio advertisements, other advertisements, use of social media or face to face meetings.

Only participants aged 18 years of age and above will be included in the study. A minimal set of exclusion criteria will be applied (subject under 18 years old, pregnant or lactating, no or limited access to internet, following a prescribed diet for any reason, including weight loss in the last 3 months, Insulin dependent diabetes, celiac disease, Crohn's, or any metabolic disease or condition that alters nutritional requirements, such as diabetes. Other than balancing the male to female ratio among recruits (with not more than a 70/30 or 30/70 distribution of males and females in each group) and balancing the age ratio (with not more than a 70/30 or 30/70 distribution of participants <45 years and > 45 years old in each group) no other stratification will be applied since the objective is to complete the proof-of-principle study in as real setting as possible. All age and sex stratification will be applied before randomisation of the participants to each level / group of personalised nutrition (0, 1, 2 and 3).
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dietary Modification
  • Behavioral: Level 1 Dietary Intake
    Level 1 - Participants will receive personalised dietary advice based on their dietary intake data alone.
    Other Name: Dietary intake Group
  • Behavioral: Level 2: Dietary Intake + Phenotype
    Level or Group 2: Participants will receive personalised dietary advice taking dietary intake and phenotypic data into account.
    Other Name: Dietary Intake + Phenotype Group
  • Behavioral: Level 3 Dietary Intake + Phenotype + Genotype
    Level or group 3: Participants will receive personalised dietary advice taking dietary intake, phenotypic and genotypic data into account.
    Other Name: Dietary + Phenotype + Genotype Group
  • Behavioral: Level 0 Control Group
    Level 0 - Control group - Investigators will provide non-personalized dietary advice for improved food choice based on standard population healthy eating guidelines.
    Other Name: Control group
  • Experimental: Level 0 control
    Level 0: Control group - participants will receive non-personalized dietary advice for improved food choice based on standard population healthy eating guidelines.
    Intervention: Behavioral: Level 0 Control Group
  • Experimental: Level 1 Dietary Intake
    Level or group 1: participants will receive personalised dietary advice based on their dietary intake data alone.
    Intervention: Behavioral: Level 1 Dietary Intake
  • Experimental: Level 2 Dietary intake + Phenotype
    Level or Group 2: participants will receive personalised dietary advice taking their dietary intake and phenotypic data ( obesity-related phenotypes and clinical biomarkers) into account.
    Intervention: Behavioral: Level 2: Dietary Intake + Phenotype
  • Experimental: Level 3 Dietary Intake + Phenotype + Genotype
    Level or Group 3 : participants will receive personalised dietary advice taking their dietary intake, phenotypic (obesity-related markers) and genotypic data into account.
    Intervention: Behavioral: Level 3 Dietary Intake + Phenotype + Genotype
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1288
April 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged >18 years old

Exclusion Criteria:

  • Subject under 18 years old.
  • Pregnant or lactating.
  • No or limited access to internet.
  • Following a prescribed diet for any reason, including weight loss in the last 3 months.
  • Subjects under medication for Insulin dependent diabetes, celiac disease, Crohn's or any metabolic disease or condition that alters nutritional requirements, such as diabetes.
Both
18 Years and older
Yes
Contact: John Mathers, Professor 4401912481133 ext 1133 john.mathers@ncl.ac.uk
Contact: Carlos A Celis Morales, PhD 4401912481141 ext 1141 Carlos.Celis@ncl.ac.uk
Germany,   Greece,   Ireland,   Netherlands,   Poland,   Spain,   United Kingdom
 
NCT01530139
Food4Me-549426
No
Newcastle University
Newcastle University
  • University College Dublin
  • Maastricht University
  • University of Oslo
  • University of Navarra
  • Harokopio University
  • University of Reading
  • National Food and Nutrition InstitutE
  • Technische Universität München
  • University of Newcastle Upon-Tyne
Principal Investigator: John Mathers, Professor Newcastle University, United Kingdom
Study Director: Mike Gibney, Professor University College Dublin, Ireland
Principal Investigator: Wim Saris, Professor •Universiteit Maastricht, Netehrlands
Principal Investigator: Alfredo Martinez, Professor University of Navarra, Spain
Principal Investigator: Julie Lovegrove, Professor University of Reading, United Kingdom
Principal Investigator: Yannis Manios, Professor Harokopio University, Athens, Greece
Principal Investigator: Iwona Traczyk, Professor National Food and Nutrition Institute, Warsaw, Poland
Principal Investigator: Hannelore Daniel, Professor Technische Universitaet Muenchen, Germany
Newcastle University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP