Strategies for Personalised Nutrition (Food4Me)

February 25, 2016 updated by: Newcastle University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

1607

Phase

  • Not Applicable

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

  • Germany
      • München, Germany
        • Technische Universitaet Muenchen
  • Greece
      • Athens, Greece
        • The Harokopio University
  • Ireland
      • Dublin, Ireland
        • University College Dublin
  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University
  • Poland
      • Warsaw, Poland
        • National Food and Nutritional Institute
  • Spain
      • Navarra, Spain
        • University of Navarra
  • United Kingdom
      • Newcastle, United Kingdom, NE45PL
        • Newcastle University
      • Reading, United Kingdom
        • University of Reading

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Level 0
Level 0: Control group - participants will receive non-personalized dietary advice for improved food choice based on standard population healthy eating guidelines.
Behavioral: Level 0
Level 0 - Control group - Investigators will provide non-personalized dietary advice for improved food choice based on standard population healthy eating guidelines.
Other Names:
  • Control group
Experimental: Level 1
Level or Group 1: participants will receive personalised dietary advice based on their dietary intake data alone.
Behavioral: Level 1
Level 1 - Participants will receive personalised dietary advice based on their dietary intake data alone.
Other Names:
  • Dietary intake Group
Experimental: Level 2
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.
Behavioral: Level 2
Level or Group 2: Participants will receive personalised dietary advice taking dietary intake and phenotypic data into account.
Other Names:
  • Dietary Intake + Phenotype Group
Experimental: Level 3
Level or Group 3 : participants will receive personalised dietary advice taking their dietary intake, phenotypic (obesity-related markers) and genotypic data into account.
Behavioral: Level 3
Level or group 3: Participants will receive personalised dietary advice taking dietary intake, phenotypic and genotypic data into account.
Other Names:
  • Dietary + Phenotype + Genotype Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in Dietary Intake at 3 and 6 months
Time Frame: Baseline, month 3 and 6.
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.
Baseline, month 3 and 6.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in phenotypic and Metabolic biomarkers at 3 and 6 month
Time Frame: baseline, month 3 and 6
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.
baseline, month 3 and 6

Collaborators and Investigators

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

Sponsor

Newcastle University

Collaborators

University of Oslo
University College Dublin
Technical University of Munich
Maastricht University
Harokopio University
University of Navarra
University of Reading
National Food and Nutrition InstitutE
University of Newcastle Upon-Tyne

Investigators

  • 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: Iwona Traczyk, Professor, National Food and Nutrition Institute, Warsaw, Poland
  • Principal Investigator: Hannelore Daniel, Professor, Technische Universitaet Muenchen, Germany

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

Helpful Links

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

August 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Food4Me-549426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be available upon request from the Project leader Professor Mike Gibney and Professor John Mathers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Dietary Modification

Clinical Trials on Level 0

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe