Clinical trial NCT01530139: Strategies for Personalised Nutrition
Official title: Personalised Nutrition: An Integrative Analysis of Opportunities and Challenges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: Maastricht University
name: University of Oslo
name: University of Navarra
name: Harokopio University
name: University of Reading
name: National Food and Nutrition InstitutE
name: Technical University of Munich
name: University of Newcastle Upon-Tyne
First posted: 2012-02-09
Enrollment: 1607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Changes from baseline in Dietary Intake at 3 and 6 months
timeFrame: Baseline, month 3 and 6.
Secondary outcomes:
measure: Change from baseline in phenotypic and Metabolic biomarkers at 3 and 6 month
timeFrame: baseline, month 3 and 6
Other outcomes:
Locations:
city: München
country: Germany
facility: Technische Universitaet Muenchen
city: Athens
country: Greece
facility: The Harokopio University
city: Dublin
country: Ireland
facility: University College Dublin
city: Maastricht
country: Netherlands
facility: Maastricht University
city: Warsaw
country: Poland
facility: National Food and Nutritional Institute
city: Navarra
country: Spain
facility: University of Navarra
city: Newcastle
country: United Kingdom
facility: Newcastle University
city: Reading
country: United Kingdom
facility: University of Reading
Study officials:
affiliation: Newcastle University, United Kingdom
name: John Mathers, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin, Ireland
name: Mike Gibney, Professor
role: STUDY_DIRECTOR
affiliation: •Universiteit Maastricht, Netehrlands
name: Wim Saris, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Navarra, Spain
name: Alfredo Martinez, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Reading, United Kingdom
name: Julie Lovegrove, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Harokopio University, Athens, Greece
name: Yannis Manios, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: National Food and Nutrition Institute, Warsaw, Poland
name: Iwona Traczyk, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Technische Universitaet Muenchen, Germany
name: Hannelore Daniel, Professor
role: PRINCIPAL_INVESTIGATOR
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