Development of functional foods

Maria Manuela E. Pintado

(mpintado@porto.ucp.pt)
CBQF-Escola Superior Biotecnologia – Universidade Católica Portuguesa

Food and Nutrition

PhD in Food Science and Technology and Nutrition
Porto 2022
Outline

Outline
▪ 1.1 Opportunities and challenges for the food industry
▪ 1.2. Types of functional foods to develop
▪ 1.3 Trends in Foods and Functional Foods
▪ 1.5 Regulatory issues
▪ 1.6 Main stages of Functional Food development
▪ 1.7 Scientific validation: bioavailability, bioactivity, toxicity
▪ 1.8 Selection and Incorporation in the food matrix
▪ 1.8 General consumer perception and acceptance

CATÓLICA PORTO
BIOTECNOLOGIA
 Tendências do século 21
‘Efficient Nutrition’
fast but nutritious and healthy
‘The Hypochondriac ‘The Time Factor’
Factor’
•More individual
•More information (portion) control
•More evidence on Health •More control over time
claims i Convenience and quality of
•More control through preparation
`food plus’, `food
minus’ and `natural i i
alternatives’

‘Guilt-free
Indulgence’ ‘Convenience Plus’
Pleasure
low & light Convenience
without compromising with restaurant quality and
on taste & texture entertainment value

Source: Reuters Business, 2000

FUNCTIONAL FOODS

Processed Foods
Urbanization SHIFT IN DIETARY PATTERNS
Modern lifestyles

Obesity, cancer, diabetes and cardiovascular

diseases.

In 2016, more than 1.9 billion adults worldwide were

overweight, and of these, over 650 million were obese.
Challenges and opportunities of food industry…
Urgent solutions to the rising cost of health care to face the increasing
chronic diseases

Increased life expectancy, demand in the elderly population for better

quality of life

The connected world has led consumers to become more knowledgeable of

other cultures, contributing to high growth of a discovery claim

Consumer
Possibilities
Research and
Innovation
Industry

Functional Foods
Functional Foods– Concept
Atualmente
mais de 100
definições
publicadas

“Whole foods and fortified, enriched, or

enhanced foods that have a potentially
beneficial effect on health when consumed
as part of a varied diet on a regular basis, at
effective levels”
Hasler et al. (2009)

“Foods that with their specific health effects

could, in the future, indicate a new mode of
thinking about the relationships between food
and health in everyday life”
Ballali and Lanciai (2012)

Bigliardi, B., & Galati, F.Trends in Food Science & Technology (2013).
Opportunities for food industry
Follow the trend of the world market
✓ promote the general state health of
consumer
✓ reduce the risk of disease

Development of safe functional food

Market Opportunities
 Challenges of food industry…

Regulation (EC) No. 1924/2006 on nutrition and health claims

made on foods-

Regulation (EU) No 432/2012 establishing a list of permitted

health claims made on foods, other than those referring to
the reduction of disease risk and to children’s development
and health
• Harmonised rules for the use of nutrition claims (such as “low fat”,
“high fibre”, etc.)

• Permitted, rejected and pending health claims (such as “reducing

blood cholesterol, beta-glucans contribute to the maintenance of
normal blood cholesterol levels, biotin contributes to normal
macronutrient metabolism etc.)
Regulations setting out the functional food

• Regulation (EC) No. 1924/2006 on nutrition and health claims

made on foods
• Regulation (EU) No 432/2012 establishing a list of permitted
health claims made on foods, other than those referring to the
reduction of disease risk and to children’s development and
health,
• Directive 2009/39/EC on general rules for foods for particular
nutritional uses
• Regulation No. 609/2013 on food intended for infants and
young children, food for special medical purposes, and total diet
replacement for weight control ('Food for Specific Groups')
NUTRITION CLAIMS
▪ low energy ▪ source of [name of vitamin/s]
▪ energy-reduced and/or [name of mineral/s]
▪ energy-free ▪ high [name of vitamin/s]
and/or[name of mineral/s]
▪ very low sodium/salt
▪ increased [name of the nutrient]
▪ sodium-free or salt-free
▪ reduced [name of the nutrient]
▪ source of fibre
▪ light/lite
▪ contains [name of the
▪ naturally/natural (linked to other
▪ nutrient or other substance] nutrition claim e.g.
▪ increased [name of the energy free ▪ naturally high in fibre
▪ low fat ▪ source of omega-3 fatty acids
▪ fat-free ▪ high omega-3 fatty acids
▪ low saturated fat ▪ high mono unsaturated fat
▪ saturated fat-free ▪ high poly unsaturated fat
▪ low sugars ▪ Since 2010 and 2012.:
▪ sugars-free ▪ high omega 3 fatty acids
▪ with no added sugars ▪ high poly unsaturated fat
▪ low sodium/salt ▪ high unsaturated fat
▪ source of fibre ▪ no added sodium/salt
▪ high fibre ▪ Reduced [name of the nutrient]:
▪ source of protein
▪ high protein
HEALTH CLAIMS
Claim that states, suggests or implies that a relationship exists between
a food category, a food or one of its constituents and health;
HEALTH CLAIMS
ca. 300 claims- Regulation 432/2012, since May 2012.c

The impact on
The impact of a psychological
function, behavior The impact on the
particular nutrient health and
to the growth and Weight control or Risk Reduction of development of
development of weight, or reduce disease children
the organism feelings of hunger
function or an increase
satiety, reduce
energy available

Art. 13.1 generally permitted Art. 14th assertions (requires

Art. 13.5. new claims (requires approval)
approval)
Health claims (constrains to the food industry
• Many claims remained "on hold" (not on the list of
approved, but they are not excluded eg: herbs) -
requires approval of EFSA
• A large number of claims were rejected
• Difficult applications due to the demanding criteria of
EFSA and high costs
• Approach similar to that of the drug approval
• Decisions will be waiting a long time (EC10-18
months, EFSA assessment 5-7 months)
• Not defined nutritional profiles
Markets opportunity – less restrictions

Functional Foods & Beverages - changes in the

Japanese functional food market make this the top
trend for 2015.
The Japanese Consumer Affairs Agency will roll out
a new health claim labeling system in 2015, which
is expected to shake up the market and drive
growth.
Compared to the current FOSHU (Foods for
Specified Health Uses) system, the regulation is
expected make non-disease health claims easier to
label.
Development of Functional Food – basic principles

Proven health benefits that Be or appears Be part of a standard diet

reduce the risk of specific similar to a and consumed on a regular
chronic diseases or conventional food basis, in normal quantities.
beneficially affect target
functions beyond its basic
nutritional functions.

What base assumptions the company should consider when they

want to develop a functional food?
Defenition of Functional food (Doyon and Labrecque (2008)
 FUNCTIONAL FOODS

300
CONSUMER PERCEPTION
Sales in billion U.S. dollars

250 ABOUT FUNCTIONAL FOODS

200 It can play an important role
in supporting their health,
150
longevity and well-being.
100
More natural forms of
50 prevention and control.
0
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 It is estimated that an annual
reduction of 20 % in health-care
expenditure is possible!
Asia Pacific North America
Europe Central and South America
Middle East and Africa
“Functional Food" Trends to 2050
Success in growing functional food market is increasingly
dependent on the establishment of a relationship of trust
with the consumer!

The food will be given to provide more added value to

consumers concerned about health

In future, the supermarket shelves will have sections with

adapted functional foods to different segments of the
population

Food science will make the best nutritional profile for each
demographic group, and for each individual.

But also looking for fresh foods naturally enriched in these

ingredients:

Fish with higher content of omega3

Tomato with anthocyanins
FUNCTIONAL FOODS
Types
• Fortified
• Enriched • Enhanced
• Altered
Fortified Product - food fortified with additional nutrients

Enriched product - food with new nutrients or components not

normally found

Modified product - food from which a harmful component is

removed, reduced or replaced by another with a beneficial effect

Improved product - in which one of the food components is

naturally enhanced
FUNCTIONAL FOODS
Types Bioactive components
• Fortified • Fatty acids (PUFA)
• Enriched • Enhanced
• Phytosterols
• Altered • Minerals
• Prebiotics
• Dietary fibres
• Probiotics
Food categories • Vitamins
• Biopeptides
• Antioxidants (Polifenols, Carotenoids)
• Bakery/cereals • Beverages
• Dairy products • Nutritional bars Common end-use
• Meat/fish/eggs • Baby food • Sports • Lowered
• Soy products • Various snack types • Nutrition cholesterol
• Fats/oils
• Weight management levels
• Immunity • Osteoporosis
• Digestive health • Certain cancer
• Cardiovascular applications
health related problems
 Development of functional foods

Positioning of products

Holistic image of health (eg

The highly specific functional
Danone Actimel-), general
products or health claims,
health promotion and
confined to small market
extension of youth - greater
niches> failure
market penetration

> success > failure

Innovation Management in the development of functional foods

Innovation process must pass the internal limits and interact with all
stakeholders throughout the supply chain (Costa & Jongen, 2006)

To access the knowledge, innovative food companies can establish formal

agreements with other actors in the production chain, well as with other
external actors such as universities and research centers.

Universities and research centers are a source of lower cost and lower
risk for acquiring new scientific and technological knowledge (exploratory
intent) necessary to develop truly innovative food products
(Nieto & Santamaria, 2007; Tether, 2002).

Optimally coordinate the multiple

relationships with the different actors involved
 Development of functional foods:

more restrictive health claim

The use of creative strategies and
alternatives to overcome the health
claim on the more restrictive legislation

Yogurt Gaius (cholesterol reduction) in Denmark was

heavily influenced by a strategic combination of
advertising media with holistic image of wellbeing and
press releases leading journalists to report more specific
information in terms of health claim, which could not have
been legally conveyed by advertising
 Development of functional foods :

Consumer: target market

General orientation of consumer health

Woman+ Man –
Health
(greater concern with family)
age > 30 anos + age > 30 anos –
(greater concern with health)

+
functional ingredient well unfamiliar functional
established and familiar ingredient
(eg omega, calcium) (xylitol, selenium)
-

high sensory quality requirement

 The consumer commits the taste for health care?

I accept functional foods if

they have good taste?

I accept functional foods

with less flavor to
conventional
replacement?

W. Verbeke. Food Quality

and Preference (2006)
Consumer attitudes towards functional foods

How frequently consumers purchase foods that promote

specific health benefits (Nielsen, 2011)
Design, development and monitoring of functional foods

B. Olmedilla-Alonso et al. / Meat Science (2013)

Design, development and monitoring of functional foods

Food engineers Specialists

Health benefits,
Raw materials, physiological
ingredients and markers, toxicity
process technology mechanisms

Nutritionists
nutritional functions

B. Bigliardi, F. Galati / Trends in Food Science & Technology (2013) 1e12

Steps required to develop a functional food

1. Selection of the functional ingredient – be aware

of: absence of scientific evidence/claim
accepted, target group, matrix, etc
2. Assessment of biological activity, bioavailability
and toxicity of the ingredient
3. Design and product formulation (product, dose
and homogenization process, and sensory
acceptability)
4. Validation of biological activity, bioavailability,
and lack of toxicity in the final product
5. Clinical trials (double-blind randomized)
6. Consumer and market studies
overcome technological losses, incompatibilities
and sensory problems.
Development of functional
foods: Which ingredient?
▪ To highlight the benefits of certain products
(lycopene in tomato juice)
▪ A product enriched with nutrients or new
components not normally found (margarine
phytosterols, probiotics, etc.)
▪ Fortify the product with certain nutrients or
bioactive compound (juice with vitamin C)
▪ Changing a product so that components can be
removed, reduced or replaced by another
substance with beneficial effects (fiber as a
substituent of fat in meat and ice cream)
▪ A food in which one of the components is
enhanced by special conditions of growth,
genetic manipulation etc. (rich in n-3 eggs
conveyed by the feed)

I. Siro´ et al. / Appetite (2008)

Where can we obtain functional ingredient?

Vegetable raw To buy an ingredient

materials with validated claim
By-products or waste and compatible with
from Food Industry our matrix

Extraction of bioactive Assure that your new

substances formulation contain the
(compound or extract) dose and nutritional
and validation of profile to have an health
efficacy claim
 Various sources of bran, their
phytochemicals, food fortifications
and metabolic roles
Journal of functional foods 14 ( 2 0 1 5 ) 255–269
Polyunsaturated Fatty Acids
Alpha-linolenic acid (ALA) + Oleic Acid
DHA + EPA
Food % ómega-3
Linseed 18.1
Nuts 6.3
Hazelnuts 0.1

Attention to
nutritional food
profile
- Dosing controlled
- Bioavailability
Evidence
Steps required to develop a functional food

1. Selection of the functional ingredient - absence

of scientific evidence/claim accepted, target
group, matrix, etc
2. Assessment of biological activity, bioavailability
and toxicity of the ingredient
3. Design and product formulation (product, dose
and homogenization process, and sensory
acceptability)
4. Validation of biological activity, bioavailability,
and lack of toxicity in the final product
5. Clinical trials (double-blind randomized)
6. Consumer and market studies
overcome technological losses, incompatibilities
and sensory problems.
 An integrated view:
• product development life cycle,
• increasing efficiency in time and costs, and
• supporting informed decision-making.

E. Younesi, M.T. Ayseli / Trends in Food Science & Technology 41 (2015) 95 -100
Health Claims - information scientifically validated

Only health claims including following

information are permitted:
• An indication of the importance of a varied and
balanced diet and a healthy lifestyle;
• The amount of food and consumption required to
obtain the claimed beneficial effect;
• Where applicable, a note addressed to persons who
should avoid consume the food;
 Artigo 15º, 16º, 17 e 19º
Requests for authorization Opinion of the Authority,
Community authorization, Modification, suspension and
revocation of authorizations

Information to the applicant and publication

Scientific of the decision in the Official Journal of the
Dossier European Union

Submission to the
Committee, of the draft
National Competent decision (within 2
Authority months)

Development of scientific European Food Safety

opinion (within 5 months, Authority
which may be extended +2 (EFSA)
months)
Scientific Validation of bioactivity and safety

Natural or synthetic compound

Solubility, permeability or
In vitro/In vivo
In vivo bioavailability problemas
antioxidant activity failure

Mechanism Improved
bioavailability

Safety Chemical
modification,
delivery systems
Toxycological evaluation Pharmacokinetics (microencapsulation)
related toxicity

Preformulation studies
Reduced
Clinical trials toxicity

Successful candidate
Ratnam et al., 2006
 Bioavailability throughout gastrointestinal tract
a-amylase 1 min
pH =5.9-6.9, 1 min
Stirring, 37ºC

compounds profile
Monitoring: biactive property
0 min
pepsin 30 min
pH =2, 1h or 2 h 60 min
Stirring, 37ºC

Pancreatin 0 min
Bile salts 60 min
pH =6, 2h 120 min
Stirring, 37ºC

Caco cells 0 min

60 min
Choi et al., 2007, Aura et al., 20005, Laurent et al, 2007
120 min
Bioavailability throughout gastrointestinal tract (INFOGEST)

Food Funct., 2014, 5, 1113

 Bioavailability in the intestine

Cultures in Caco-2 and Caco-2

120
0.10 mg/mL
100 1.0 mg/mL
[COS3] (µg/mL)

5.0 mg/mL
80
Caco-2 cell 10.0 mg/mL
60

(mucosas) + HT29
40
20
0
0 50 100 150 200
Time (min)

140
0.10 mg/mL
120 1.0 mg/mL
5.0 mg/mL
[COS3] (µg/mL)

100 10.0 mg/mL

80
Caco-2 plus HT29
60
40
20
0
0 50 100 150 200
Time (min)

Time-course apical to basolateral penetration of COS3,

at different initial concentrations, on a Caco-2 cell
monolayer and Caco-2 plus HT29 cells monolayer .
hematological biochemical Organ weight
parameters parameters

Toxicicity
In vitro - Cells - Animals - Clinical trials
Steps required to develop a functional food

1. Selection of the functional ingredient - absence

of scientific evidence/claim accepted, target
group, matrix, etc
2. Assessment of biological activity, bioavailability
and toxicity of the ingredient
3. Design and product formulation (product, dose
and homogenization process, and sensory
acceptability)
4. Validation of biological activity, bioavailability,
and lack of toxicity in the final product
5. Clinical trials (double-blind randomized)
6. Consumer and market studies
overcome technological losses, incompatibilities
and sensory problems.
Development of new functional foods
- incorporation

Matrix (food or drink?)

Physical and chemical

properties of the matrix
(compatibility)

Market trends

Consumer acceptance

Carrier selection
Top trends

• 1. Discovery: The Adventurous Consumer - The food and beverage industry is

increasingly focusing on satisfying the adventurous consumer, with consumers
moving out of their comfort zones to explore bolder flavors and multisensory food
experiences. There is a focus on heightened sensory delivery, often combined with
an element of the unexpected.
• 2. The Plant Kingdom - The plant-based market shows no signs of slowing
down and companies and brands are greening up their portfolios to attract
mainstream consumers who want to add more plant-based options to their diets, but
also achieving a healthy and sustainable balance between meat and vegetables,
rather than adopting an all-or-nothing way of eating.
• 3. Alternatives to All - As more consumers pay attention to health and
sustainability, replacement foods and ingredients are on the rise. Health remains the
number one reason to buy food alternatives, with one in two US consumers
reporting that health, is a reason for buying alternatives to bread, meat or dairy. The
search for alternative proteins has resulted in rising use of black beans, lentils,
peas, rice, nuts and seeds, chickpea and even insects as protein.
• 4. Green Appeal - The industry is increasingly committing to answering
customer expectations around sustainability. This is driving corporate goals, as
manufacturers commit to sustainable product and packaging development with a
range of initiatives. This includes waste reduction through upcycled ingredients and
post-consumer recycling, as well as improved biodegradability and new technology.
• 5. Snacking: The Definitive Occasion - For most consumers, snacking is
a part of daily life and always has been. What is changing, however, is the way
people think about snacking and what is considered a snack. Snacking is no longer
the optional extra, but the definitive occasion. It is a central focus of innovation
across all food and beverage categories, with 10 percent average annual growth of
global tracked with a snacking claim over the past five years.

Innova Market Insights 2019

Healthy Unhealthy

L.D.T. van der Zanden et al. / Food Quality and Preference 42 (2015) 130–138
Interlinked processes and considerations in fermented
beverage production and development.
 Impact of thermal treatment and hydrolysis by
Alcalase and Cynara cardunculus enzymes on the
functional and nutritional value of Okara
Soy
protei
Raw
soybean
Soaked
Okara n
soybeans
(1kg)
water

Okara Soya
beverage
Used:
➢ Traditional
~ 1.1 kg okara dishes
Glenise Voss ➢ Agriculture
➢ Feed
Nutritional:
50% fiber Humidity
30% protein (~ 80%)
11% lipids
Isoflavones
Hydrolysis of okara

NAOK
and
Fresh AOK
Proteases
Dried at 65 ºC Alcalase from Cynara
cardunculus
Heat
treatment
Enzymatic
hydrolysis

▪ Hydrolysis degree
▪ Peptide profile
▪ Protein profile
▪ Antioxidant activity
▪ Antihypertensive activity
▪ Peptides sequence (MALDI-
TOF)
 Antioxidant activity in hydrolysates of okara

Alcalase

The activity increased 10 times

by enzymatic hydrolysis

Cynara cardunculus extract

 ACE-inhibitory activity
Chapter 4- Enzymatic hydrolysis of okara

ACE-inhibitory activity IC50 (µg protein/mL) for NAOK and AOK hydrolyzed with Alcalase and
proteases from Cynara cardunculus and unhydrolyzed (control)

ACE-inhibitory activity IC50 (µg protein/mL)

AOK NAOK
Sample
AL CY AL CY
Control 536.90 ± 0.91 >800

E/S 1.1 and 2.5 h 21.87 ± 0.51 48.59 ± 7.22 22.11 ± 5.31 59.09 ± 6.70

E/S 1.1 and 5 h 9.97 ± 0.63 54.30 ± 0.70 12.33 ± 3.97 62.55 ± 3.74
Values are expressed as average ± standard error (n= 2). AOK: dry okara previously autoclaved, NAOK: dry okara
not autoclaved, AL: Alcalase and CY: proteases from Cynara cardunculus.

Peptide
Ace- inhibitory ✓ Hydrophobic amino acid residues
activity ✓ Proline, lysine, arginine or aromatic amino acids
✓ Arginine, histidine, tryptophan, tyrosine phenylalanine
 Hydrolyzed Okara

L. rhamnosus B. animalis ssp. Hydrolyzed

Co-culture
R11 lactis Bb12 Okara
OkaLR6 OkaBb6 OkaMix6 OkaNF

Production
of Okara
beverage
• Prebiotic
• Probiotic
 Fermentation of okara

Okara beverage maintained the total

viable cells counts(B. animalis Bb12
and L. rhamnosus R11: 9 log
CFU/mL) throughout storage.

Isoflavones
Glycosid Aglycone
es s

CATÓLICA PORTO
BIOTECNOLOGIA
New functional canned tuna that incorporate a set of innovative
aspects, of which the following stand out: (i) enrichment in
omega-3 fatty acids with protection against cardiovascular
disease; (ii) incorporation of plant sterols / stanols with an
impact on the reduction of total cholesterol levels; (iii)
synergistic combination of omega-3 fatty acids and plant sterols
with maximized impact on cardiovascular disease;

3 slices of sliced bread and tuna in fish oil containing 5

g of EPA + DHA
Claimed effects such as maintaining blood pressure
and triglyceridemia and maintaining normal cardiac
function
 Market application

Incorporation of peptide extracts, and beta-glucans:

• Snack with cashew and peptide extract with reduced

content of sodium

• Cereal bars with peptide yeast extract

• Fruit smoothies with peptides
 Development of a functional bread
formulation with barley flour

functional claim Requires 0.81 g beta-

3 g of beta-glucan per glucans
day
0.81 g beta- 4 barley bread slices:
glucans
3.24 g beta-glucans
Nutritional per day
recommendations of 4 0.81 g beta-
glucans
servings of bread 50 g / day
0.81 g beta-
glucans

Journal of Cereal Science 53 (2011) 225e230

 Cholesterol Reduction: 1 g of oat beta-
glucan, oat bran, barley, barley bran

4 barley bread slices:

3.24 g beta-glucans Daily intake of 3 g of beta-glucans
per day

Reduction of serum glucose levels after

meals: The claim can be used only for
food which contains at least 4 g of oat
beta-glucan or barley, per 30g
carbohydrate portion quantified as part
of meal
Development of new functional foods
- incorporation

What problems to overcome?

• Organoleptic problems
• Factors affecting stability
• Losses in storage.

Microencapsulation,
altered ingredient…
Technology - Challenge and according to the ingredient matrix

Traditional Technology - Formulation of

some ingredients- eg some vitamins and
minerals and soluble fiber, etc.

New technologies - protection of

physiologically active compounds or mask
taste and aroma - Micro and Nano
encapsulation and edible films and coatings
Steps required to develop a functional food

1. Selection of the functional ingredient - absence

of scientific evidence/claim accepted, target
group, matrix, etc
2. Assessment of biological activity, bioavailability
and toxicity of the ingredient
3. Design and product formulation (product, dose
and homogenization process, and sensory
acceptability)
4. Validation of biological activity, bioavailability,
and lack of toxicity in the final product
5. Clinical trials (double-blind randomized)
6. Consumer and market studies
overcome technological losses, incompatibilities
and sensory problems.
Steps required to develop a functional food

1. Selection of the functional ingredient - absence

of scientific evidence/claim accepted, target
group, matrix, etc
2. Assessment of biological activity, bioavailability
and toxicity of the ingredient
3. Design and product formulation (product, dose
and homogenization process, and sensory
acceptability)
4. Validation of biological activity, bioavailability,
and lack of toxicity in the final product
5. Clinical trials (double-blind randomized)
6. Consumer and market studies
overcome technological losses, incompatibilities
and sensory problems.
 Claims consumer perception

Nutricionist/food engenering/etc.. √

G. Nocella, O. Kennedy / Food Policy 37 (2012) 571–580

Current difficulties….

• Optimal levels and toxic levels are mostly unknown

• Concentration to incorporate in the food versus
DDR
• Food quality / effect
• Consumer information-Marketing
• Restrictions of authorized claims
• Cost Validation
• Clinical trials
• Support national-development organizations -
labeling
 Food habits in 2050
Ferran Adrià
…..as a society our life expectancy is much higher than it has ever been
and we should mind our diets to better our overall health.
The diets and tastes of those interested in sports or in health or in the
simple pleasures of food won’t be the same. We’re heading towards an
“A la Carte” diet. That is to say, each person will decide for themselves.
mpintado@porto.ucp.pt

www.esb.ucp.pt
Thank you for your
attention!