Food4Me Personalised nutrition: An integrated analysis of opportunities and challenges.

The field of personalised nutrition is relatively new and has not yet been
explored in great depth. More work is needed before it can be successfully
applied to the general public. Personalised nutrition investigations to date
have focused solely on genetic responsiveness to diet. This research intends to
conduct a *proof of principal study* by testing the delivery of personalised
nutrition at three different levels to determine whether providing more
personalised dietary advice leads to better compliance and health outcomes
compared to standard population advice. It will be the first study of its kind
and aims to produce the state-of-the-art in the area.

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
advice/modifications could be made to optimise health and lower disease risk.
Although research in this area (known as nutrigenomics) has deepened and made
significant advances, the translation of this knowledge to a sound public
health service has not yet been reached. Despite this, the potential of
personalised nutrition in advancing public health awareness and delivery is too
great to be dismissed without further exploration.
Emerging nutrition research continues to provide convincing benefits for the
implementation of personalised nutrition in health care. In the US, the FDA
established a Division of Personalised Nutrition within its National Center for
Toxicological Research. In the EU, the FP6 funded Network of Excellence NuGo-A
(The European Nutrigenomics Organisation) took a global lead in this area,
establishing standards for research in the field, promoting concerted research
programmes, reaching out to stakeholders and above all, in training a new
generation of nutritionists in the application of modern molecular biology to
the study of food and health.
Now, that the knowledge has deepened, it is time to test the delivery of
personalised nutrition and explore its potential benefit in practice. The
translation of such research into a trusted public health nutrition service,
built on solid science is central to the present project.

The Food4Me study aims to demonstrate the validity of delivering personalised
nutrition advice at varying levels in a cohort across 7 EU states:
The objective is to challenge the current view that personalised nutrition has
to be rooted solely in genetic responsiveness to diet. It will study the
development of a personalised nutrition model at three levels (below), each
with more tailored personal advice and determine whether providing more
personalised feedback leads to better compliance and health outcomes compared
to providing standard population advice:

• Level 0: Control group - will receive non-personalised dietary advice for
improved food choice based on standard population healthy eating guidelines
• Level 1: will receive personalised dietary advice for improved food choice
based on the analysis of an individual*s current dietary intake;
• Level 2: will receive the same as level 1 with the introduction of using
phenotypic data (body and blood biochemistry measurements) in addition to the
dietary data for providing more tailored personalised dietary advice;
• Level 3: will receive the same as level 2 with the introduction of using
genotypic data (genetic analysis) in addition to the dietary and phenotypic
data for providing more tailored personalised dietary advice.

A detailed overview of the research design is provided in the protocol (page 12)

A total of 160 participants will be recruited and allocated to an intervention
group (level 0,1, 2, and 3). These will be further split into a *high or low
intensity group* and all will receive a specific level of dietary advice and
feedback. Advice will be consistent with healthy eating guidelines and feedback
will not be diagnostic. In order to mimic the real-life setting of such a
service, the study will be conducted via the internet with postage and
telephone calls used where necessary.

Below is an outline of the design:

ACTIVITY HIGH
INTENSITY INTERVENTION (N=80) LOW INTENSITY INTERVENTION (N=80)

Non personalised healthy eating 0, 1, 2, 3
and 6 month 0, 3 and 6 month
guidelines (level 0)

Feedback based on dietary intake 0, 1, 2, 3
and 6 month 0, 3 and 6 month
assessment and PA monitor *
(level 1)

Feedback based on dietary intake 0, 1, 2, 3
and 6 month 0, 3 and 6 month
assessment + PA monitor +
phenotypic assessment ** (level 2)

Feedback based on dietary intake 0, 1, 2, 3
and 6 month 0, 3 and 6 month
assessment + PA monitor +
phenotypic assessment +
genetic characteristics *** (level 3)


* PA: physical activity monitor, provided by Philips
(www.directlife.philips.com)
** Phenotypic assessment refers to body measurements (height, weight, waist,
hip and leg circumferences) and blood biochemistry assessment (from
finger-prick blood spot samples)
*** Genetic characteristics refers to the measurement of genetic variation
relating to nutrition.

The delivery of personalised dietary advice will be undertaken by qualified
nutritionist in each of the 8 Recruitment Centres. Such dietary advice will be
based on different pieces of information depending on group to which the
volunteer is assigned.


ACTIVITY HIGH
INTENSITY INTERVENTION (N=80) LOW INTENSITY INTERVENTION (N=80)

Non personalised healthy eating 0, 1, 2, 3 and
6 month 0, 3 and 6 month
guidelines (level 0)

Feedback based on dietary intake 0, 1, 2, 3 and 6
month 0, 3 and 6 month
assessment and PA monitor *
(level 1)

Feedback based on dietary intake 0, 1, 2, 3 and
6 month 0, 3 and 6 month
assessment + PA monitor +
phenotypic assessment ** (level 2)

Feedback based on dietary intake 0, 1, 2, 3 and
6 month 0, 3 and 6 month
assessment + PA monitor +
phenotypic assessment +
genetic characteristics *** (level 3)


* PA: physical activity monitor, provided by Philips
(www.directlife.philips.com)
** Phenotypic assessment refers to body measurements (height, weight, waist,
hip and leg circumferences) and blood biochemistry assessment (from
finger-prick blood spot samples)
*** Genetic characteristics refers to the measurement of genetic variation
relating to nutrition.

A minimal risk is associated with the use of finger-prick blood sampling.
However due to the nature of capillary blood, the pin-prick blood clots on
average within 30 seconds and heals quickly with minimal discomfort. This is
similar to the procedure commonly used at home by diabetics to test their blood
glucose levels. It is universally considered safe to be conducted without the
presence of medical supervision. A video demonstration will be provided on the
website, a hard copy of instructions with debriefing will be provided in the
collection pack, along with the contact details of the study investigators
should any issues arise.

Subjects will receive healthy eating and lifestyle advice which we expect to be
useful to them. In addition, subjects will receive information relating to
their health status e.g. cholesterol or blood glucose level, either during or
on completion of the study. By participating, subjects will be making a
relevant contribution to nutrition research.