Strategies for Personalised Nutrition (Food4Me)
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|ClinicalTrials.gov Identifier: NCT01530139|
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : February 26, 2016
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 or disease||Intervention/treatment||Phase|
|Dietary Modification||Behavioral: Level 1 Behavioral: Level 2 Behavioral: Level 3 Behavioral: Level 0||Not Applicable|
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 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.
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 (Clinical Trial)|
|Actual Enrollment :||1607 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personalised Nutrition: An Integrative Analysis of Opportunities and Challenges|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||December 2014|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530139
|Technische Universitaet Muenchen|
|The Harokopio University|
|University College Dublin|
|National Food and Nutritional Institute|
|University of Navarra|
|Newcastle, United Kingdom, NE45PL|
|University of Reading|
|Reading, United Kingdom|
|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|