Strategies for Personalised Nutrition

Personalised Nutrition: An Integrative Analysis of Opportunities and Challenges

Sponsors

Lead Sponsor: Newcastle University

Collaborator: 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

Source Newcastle University
Brief Summary

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.

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).

Overall Status Completed
Start Date August 2012
Completion Date December 2014
Primary Completion Date August 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes from baseline in Dietary Intake at 3 and 6 months Baseline, month 3 and 6.
Secondary Outcome
Measure Time Frame
Change from baseline in phenotypic and Metabolic biomarkers at 3 and 6 month baseline, month 3 and 6
Enrollment 1607
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Level 1

Description: Level 1 - Participants will receive personalised dietary advice based on their dietary intake data alone.

Arm Group Label: Level 1

Other Name: Dietary intake Group

Intervention Type: Behavioral

Intervention Name: Level 2

Description: Level or Group 2: Participants will receive personalised dietary advice taking dietary intake and phenotypic data into account.

Arm Group Label: Level 2

Other Name: Dietary Intake + Phenotype Group

Intervention Type: Behavioral

Intervention Name: Level 3

Description: Level or group 3: Participants will receive personalised dietary advice taking dietary intake, phenotypic and genotypic data into account.

Arm Group Label: Level 3

Other Name: Dietary + Phenotype + Genotype Group

Intervention Type: Behavioral

Intervention Name: Level 0

Description: Level 0 - Control group - Investigators will provide non-personalized dietary advice for improved food choice based on standard population healthy eating guidelines.

Arm Group Label: Level 0

Other Name: Control group

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility:
Technische Universitaet Muenchen | München, Germany
The Harokopio University | Athens, Greece
University College Dublin | Dublin, Ireland
Maastricht University | Maastricht, Netherlands
National Food and Nutritional Institute | Warsaw, Poland
University of Navarra | Navarra, Spain
Newcastle University | Newcastle, NE45PL, United Kingdom
University of Reading | Reading, United Kingdom
Location Countries

Germany

Greece

Ireland

Netherlands

Poland

Spain

United Kingdom

Verification Date

February 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Level 0

Type: Placebo Comparator

Description: Level 0: Control group - participants will receive non-personalized dietary advice for improved food choice based on standard population healthy eating guidelines.

Label: Level 1

Type: Experimental

Description: Level or Group 1: participants will receive personalised dietary advice based on their dietary intake data alone.

Label: Level 2

Type: Experimental

Description: 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.

Label: Level 3

Type: Experimental

Description: Level or Group 3 : participants will receive personalised dietary advice taking their dietary intake, phenotypic (obesity-related markers) and genotypic data into account.

Acronym Food4Me
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov