Functional Foods and Nutrition Research
14th October 2014
Mary E Penny
Instituto de Investigacion Nutricional
Big Business and increasing
Definition of Functional Foods
Food with added health benefits beyond the usual nutritional value
No single agreed definitionUsually excludes “supplements”
FoodInnate health benefits
“Natural” without modification
Examples:
•Quinoa (fiber and antioxidants)
•Liver (vitamin A)
•Orange juice (vitamin C)
Enhanced
Examples:
•NaturalPotatoes selected for high iron content
•BioengineeredGolden rice (Vitamin A)
Food with added/altered substance
Reduction of ingredient Example:
Low fat milk
Added ingredient: Examples:
Fermenting bacteria (yogurt)
Milk with added Vitamin D/iron/zinc
Spread with added phytosterol
or
May involve more than one change
What are Functional Foods?
“Functional” maybe a property of a whole type of food
Fruits and vegetables
Whole Grains
Property of a specific “ingredient “ of the food
Foods and Food components
Fiber,Vitamin A
ZincAntioxidant
Protein
With increasing interest in “Health” benefits of food there came an increasing tendency to make health claims for foods and so a need for
definitions and regulations especially for Foods that have been modified
Examples of Categories: Institute of Food Technologists
Functional Food Task Force of International Life Sciences Institute (Europe) ILSI EuropeInitiated a “concerted action project” in 2001 FUFUSE (Functional food science in Europe)
EU - Foods with scientifically substantiated benefits for health and/or performance above normal
nutritional functions
Health ClaimsProcess for the assessment of Scientific support for claims on food
(PASSCLAIM – 2007) Beyond PASSCLAIM – New Guidance (2009)
Japan leader in Functional foods 1980s “Foods for specialized health use”
Purpose: Food products eligible for
ILSI Europe: Beyond PASSCLAIM 2010
The EU Concerted Action - Two types of health claims relevant to functional foods,
must always be valid in the context of the whole diet and must relate to the amounts of foods normally consumed.
These are:1. TYPE A: "Enhanced function"claims that refer to specific physiological, psychological functions and biological activities beyond their established role in growth, development and other normal functions of the body.This type of claim makes no reference to a disease or a pathological state, e.g. certain non-digestible oligosaccharides improve the growth of a specific bacterial flora in the gut; caffeine can improve cognitive performance.
2. TYPE B "Reduction of disease-risk "claims that relate to the consumption of a food or food component that might help reduce the risk of a specific disease or condition because of specific nutrients or non-nutrients contained within it (e.g. folate can reduce a woman's risk of having a child with neural tube defects, and sufficient calcium intake may help to reduce the risk of osteoporosis in later life).
Possible health benefits
Reduction of specific illness or deficiency –
disease risk
Maintenance of health (Enhanced
function)
Treatment or management of
illness
Gastrointestinal health
The gut microbiome
Linear growth in infancy
Antioxidants – effects on ageing
Improved sports performance
Mental health – memory
Calcium - osteoporosis
Vitamin A – night blindness
N-3 PUFA – Cardiovascular risk
Folic acid – Spina bifida
Low fat – overweight
Gluten free – celiacs
Low glycemic index – Diabetes M
European commision: Functional foods 2010
Objective of the workshop was to provide guidance to substantiate health claims on foods
Food producers, manufacturers, regulators, public needed to know the the evidence on which claims could be made, the basis for
claims and the process of regulating claims – note that the concern was to regulate “claims” not “food”
Not an easy task:•Risk assessment – safety•Changing priorities in health – epidemic of non communicable diseases •Context of the rest of the diet•Variability across consumers•Links between diet and health not always known
CODEX – Alimentaria provides international regulations and standards with regard to foodConsiders safety and scientific validity of claims about foods – doesn´t specify “Functional foods”Same framework as conventional foods
2009 ILSI workshop
Lupton JR. Scientific substantiation of claims in the USA: focus on functional foods. Eur J Nutr 2009;48 (suppl 1):S27-S31
How can research help define health claims?
Design of a study to assess Functional Foods and their components
Functional food Consumption/Intake (Bio) markers Health change(Health outcome)
Food or food component should be characterized.Minumal dose definedMechanism of action useful but not essential
Stability,
InteractionsFor instance a food with added mineral might be eaten with high fiber or phytate foods lowering bioavailability. Breastmilk
Organoleptic propertiesMultimicronutrients, Fish
Safety
Should comply with existing regulation
How will cooking affect it – example DHA and high temperature cooking
How will storage affect it?
Study Design
Target population : who do we want to benefit
Study group must be representative of target groupAgeCultural considerations/socio-economicDietary practices/mores
Functional food Consumption/Intake (Bio) markers Health change(Health outcome)
Example : Cereal with Probiotic to reduce diarrhea would need to be targetted at children 0-2 years, population with high diarrhea rates, eating cereal paps,
Healthy vs “not healthy”Low, normal and High respondersPhysical activity levelAppropriate controls
Study Design
Design of a study to assess a Functional Food
Functional food Consumption/Intake (Bio) markers Health change(Health outcome)
Dose/amount should be consistent with normal consumptionAdequate duration and follow-upFood matrix and dietary context
Monitoring of compliance
Study Design
Design of a study to assess a Functional Food
Functional food Consumption/Intake (Bio) markers Health change(Health outcome)
Intermediate outcome – how can it be measured?Definitive outcome (Endpoints) How can it be measured?
Endpoints maybe difficult to measure, long time
Markers are often needed/used
Should be biologically valid (Known relationship with the outcome)Known variability among target groupShould change in statistically significant way
Outcomes
Claims should take into account the totality of of the data
Study Design
Consumption of functional food component
Markers of Exposure to functional food component
Markers of target function/biological response
Markers of intermediate endpoint
Enhanced target function
Reduced risk of disease
ENHANCED FUNCTION CLAIMS
REDUCTION OF DISEASE RISK
CLAIMS
The FUFOSE strategic scenario of markers for use in the scientific support of claims for foods
Agget PJ The Process of Assessment of Scientific Support for Claims on FoodEur J Nutr 2009; 48 Suppl 1:S23-S26
Intermediate measurements: Markers
Biological function: Bacterial populations in the gut (probiotics)
Key stage in disease development: Bone densityFlow mediated dilatation for CVD
Antioxidant measure
Glycemic index
Hemoglobin
Satiety-consumption
Muscle strength
Lipid profile
Markers
Nutrigenomics: Changes in gene expression as a result of dietary nutrients
Adverse Event reporting
Other names: Co-effects, Co-events, side effects
Events will always occur, complaints cannot be avoided But important to record, for safety monitoring, ethics, and may be expected for publication
Adverse events
Registration of trials: Pros and ConsAllows meta-analysis and prevents publication bias – Patenting issues
Types of studies
Animal studies provide information on mechanisms of action, biomarkers, potential benefits
Longitudinal epidemiological observation studies in humans including detailed dietary studies provide initial evidence eg Fruits and vegetables – but is it enough?
But trails will be needed for health claims
Single arm studies are not acceptable
Randomized control studies (Gold standard)
Cross over and parrallel designs
Longitudinal RCTs - depends on outcome (prevention of anemia, increased sports performance relatively quick, prevention of dementia long time)
Discussion about Pharmacological approach to Food trials - but evidence is needed!
Type of Studies
Population characteristics, numbers/sample size
Consent process
Inclusion and exclusion criteria/screening
Randomization
Delivery of food, direct observation, packaging, amounts, measurement; surveillance
Adverse effects surveillance
Loss to follow-up
Outcomes: Measurement of outcomes, duration
Randomized controlled Trials
Political/regulatory aspects in the countryWhat are the local regulations about food additives?,Human studies and clinical trial regulations?
Dietary Reference Intakes needed for a wider range of nutrients
Discussion about “Qualified health claims: “may be beneficial”Differences between countries USA, Japan, EU
Other considerations
Mind-Map Of Study Design
Hendriks H and Welch R. Beyond PASSCLAIM. 2010 – ILSI Europe report series
Summary Mind-map - Preparations
Summary - Mind-map: More thoughts on design
Gracias
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