Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Strategies for Personalised Nutrition (Food4Me)

This study is ongoing, but not recruiting participants.
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: October 30, 2014
Last verified: October 2014
  Purpose

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.

Condition Intervention
Dietary Modification
Behavioral: Level 1
Behavioral: Level 2
Behavioral: Level 3
Behavioral: Level 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Personalised Nutrition: An Integrative Analysis of Opportunities and Challenges

Further study details as provided by Newcastle University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1288
Study Start Date: August 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Dietary + Phenotype + Genotype Group

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01530139

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

Additional Information:
No publications provided

Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT01530139     History of Changes
Other Study ID Numbers: Food4Me-549426
Study First Received: February 1, 2012
Last Updated: October 30, 2014
Health Authority: Ireland: Research Ethics Committee

ClinicalTrials.gov processed this record on November 24, 2014