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General Information and Introduction

of Functional Food especially in Japan

Kozo Asano
Applied Microbiology, Graduate School of Agriculture,
Hokkaido University Sapporo, Japan
Why are functional foods popular in Japan?
Back grounds of functional foods.

The average life expectancy in Japan.

Women 83 years, Men 76

Good Sanitation
Changing of dietary style
Advancement in medical technology,

Live long with health







1960 1965 1970 1975 1980 1985 1990 1995

Foods consumption /person 農林水産省「食糧需給表」

Rice, milk, yogurt, fruits, fish, meat

Changing of Food style in Japan (1)
Conventional Japanese Foods

Cereals (millet, barnyard grass, etc)

Potato, Rice,

High salt
High carbohydrate and low protein

Short life span

Tuberculosis, Stroke, etc.
Changing of Food style in Japan (2)
Import of Western Food style

A more Protein; chicken, beef, pork, diary products

A less salt

A good dietary balance A Longer life span

A more Western diet;

more fat but less fiber and vegetables
25% of the Japanese population above the age of 65 by 2010
Why Functional Foods ?
The increase in diet-related / life-style-related diseases
such as obesity, diabetes, arteriosclerosis, cardiovascular
diseases, cancers.
Increased scientific interest in and public concerns about
the relationship between diet and diseases
Systematic investigation toward development of
functional food to isolate/identify/synthesize active
components of specific tertiary functions in foods ; and to
design products with potential for health maintenance or
disease risk reduction
What are Food Functions ?
Primary function (Nutritional function)
- to supply nutrients for nourishing the human body

Secondary function (Sensory function)

- to provide palatability and satisfaction

Tertiary function (Regulatory function)

- to modulate or strengthen physiological systems of the human body :

Regulation of basic metabolic processes, Defense against oxidative

stress, Regulation of gastrointestinal physiology, Modulation of
immune function
History of Functional Foods in Japan
1984 -89
① Systematic Analysis and Development on Food Function
(1984-87) ⇒ Functional Foods
② Analysis of Food Function Physiological Regulations (1988-90)
③ Analysis of Functional Foods and Their Molecular Design (1992-94)
1991Regulations for Foods for Specified Health Use
(Nutrition Improvement Law )
1998 -2000 Deregulations on Vitamins and Minerals for Food Use
2001 Regulations for Foods with Health Benefit Claims
(Food Sanitation Law)
- Foods with Nutrient Function Claims
- Foods for Specified Health Use
Drags, Functional Foods, and usual Foods

Foods for Foods with [Unregulated]

Foods for
special specified health Conventional
dietary uses (FOSHU)
claims foods
Product-based Standard (including the
(other approval system specification majority of so-
than system called health
FOSHU) foods)
Nutrient contents Nutrient contents Nutrient contents
labeling labeling labeling

Other function claims Nutrient function

Attention and warning Attention and
Statements warning
Foods for specified health uses
FOSHU status, the government-
approved functional foods that can make
health claims (regulated functional
Product-based approval system
Foods with nutrient function claims
Standard specification system
Nutrient contents labeling
Attention and warning
Definition of Foods for Specified Health Uses

* Foods that contain functional substance (s) that affect

the physiological function and biological activities of
the body.
* Foods that claim that if used in the daily diet, one can
hope for a specified health benefit such as gastro-
intestinal conditions, blood pressure, and blood
cholesterol level, among others.
* Foods that must be evaluated individually and approved
by the government.
* FOSHU can take conventional food forms as well as
capsule and tablet forms.
Functional Foods = Evidence based foods
How to make an “evidence”?
Reproducible methods
A third person can get same results
Double blind test
test samples
Traditional “functional” foods No reproducible evidence
Ameal S
Calpis Co. Ltd.

A fermented milk drink.

FOSHU-approved products.
Functional components are tripeptides of two
proline amino acids and a third isoleucine or
valine amino acid.
The health claim is that it is suitable for people
with mild hypertension.
These amino acid sequences are found in b-
and k-casein, two milk proteins.
Inhibition of Andiotnesin converting enzyme

When milk was fermented with Lactococcus lactis, the peptide

which inhibit ACE activity. in vitro
Changes of blood pressure in SHR rat with
the fermented milk included in feed

Fermented milk
Fermented milk
Fermented milk

The fermented milk was feed from 7 days baby rats everyday
with .025 to 2.5% in feeds . (Nakamura et al. 1986)
SHR: Natural mutant of High blood pressure rat
Changing blood presser in adult rats

Fermented milk

The fermented milk feeded to adult rats at 0 time.

Blood presser were decreased with significant difference.
What are substances decreasing blood pressure?

Purification and identification of active

compounds in the fermented milk

Column chromatography


Two active peptids were found

“Mechanism analysis”
Are the tri-peptides are true active compounds?
Dose response?

Enough close relation ships were found between

the peptides added and changes of blood pressure.
Nakamura et al. 1986
“Mechanism analysis”
Where is the action point of the fermented milk?

Fermented milk
Human trial Effect on higher blood presser patients

Thirty patients who showed higher bled pressure divided in to two

gropes, then they drink 95ml of the fermented milk (containing 3.4
mg of the tri- peptide) everyday, or for another drank “placebo”..
Functional Action to body

Foods, or
Amount of substance
What must be labeled in addition to the nutrient
function claim?

• Standard amount of daily intake

• “Food with Nutrient Function Claims”
• Percentage of the amount of the nutrient contained in the
recommended amount of daily intake compared to the
recommended dietary allowance of the nutrient
• Method of intake and warning message
• Method of use or storage
• “Unlike Foods for Specified Health Uses, this food product
has not been evaluated individually by the Ministry of
Health, Labor, and Welfare”
Guidelines for the claims of FOSHU

The claims shall not include diagnosis, treatment or prevention of

diseases (Pharmaceutical affairs Law) and shall be limited to the items
given below :
Maintenance and improvement of indices of physical conditions which
can be easily measured ; “Helps maintain normal glucose levels”,
“Helps promote decomposition of body fat”
Maintenance or improvement of good physical conditions and/or
biological functions; “Helps improve absorption of calcium”
Improvement of subjective and temporary, but not persistent or chronic,
changes in physical conditions; “Helpful for those who feel physically
Reduction of Disease Risk Claims is not allowed
Foods for Specified Health Uses (FOSHU)
371 Foods Approved as of Sep. 2003, 452 in Sep. 2004

“Health Benefit Functional Ingredients FOSHU Share

“Helps maintain good gastro- Oligosaccharides, Lactobacillus, 190 51 %
intestinal condition” Bifidobacterium, Dietary Fiber products
“Good for those who have Soy Protein, Peptides, Dietary 63 17 %
high serum cholesterol / Fiber, Diacylglycerol, Plant Sterol
triglycerides” / Stanol (Esters)
“Good for those who have Peptides, Glucosides 28 8%
high blood pressure”
“Helps improve absorption of CPP, CCM, Soy Isoflavonoids, 23 6%
calcium (minerals)” Oligosaccharides, MBP, Heme
“Good for those who have Dietary Fiber, Albumin, 41 11 %
high blood glucose” Polyphenols, L-Arabinose

“Helps maintain strong and Xylitol, Polyols, 26 7%

healthy teeth” Tea Polyphenols, CPP-ACP
Table 1 FOSHU Foods / Ingredients
indigestible dextrin
galacto oligosaccharides
calcium as citrate malate
heme iron
isomalto oligosaccharides
rice globulin
eucommia leaf glycoside
soybean oligosaccharides
lactobacillus GG
fructo oligosaccharides
xylo oligosaccharides
wheat bran casein phospho peptide
casein dodeca peptide
soy protein
Type of foods of FOSHU
Types of Foods %
Drinks 34
Fermented Milk 20
Confectionery 14
Table Sugar 6
Rice, Noodles, Cereal 6
Meat, Fish, Soy Bean processed foods 5
Soups 5
Cooking Oil, Vinegar, Margarine 4
Soy Milk 2
Others 4
Foods for Specified Health Use (FOSHU) Market

150 Products
Total Sales
50 (Billion Yen)
1997 1999 2003
Market Size by Specified Health Use

1997 1999 2001

Tooth 0.0 0.4 18.7
Mineral Absorption 9.2 4.5 11.8
Blood Sugar 0.7 0.5 18.4
Blood Pressure 1.4 7.2 10.0
Neutral Fat 0.0 7.0 15.2
Cholesterol 0.0 0.4 2.8
GI Oligosaccharides 10.4 9.1 5.6
GI Dietary Fiber 11.9 11.6 12.8
GI Lacto Bacillus 97.9 186.3 317.1
Health in intestinal tract
foods that contain specific nutrients that are
required by individual intestinal bacteria species
for growth

Probiotic :
a preparations of viable microorganisms which are
added to the diet of humans to control the growth of
undesirable / less desirable microorganisms in the
gastrointestinal tract. e.g. yogurt, kefir

Germ-free, male
Germ-free, female
Conventional, male
Conventional, female


12 16 20 24 28 32 36
Months of ages
Survival curve between germ-free and
conventional animals (Gordon et al., 1966)
Bifidobacterium Bacteroides Anaerobic cocci
Representatives of cultured fecal bacteria

Enterococcus Clostridiun Clostridium

Bacteroides / Prevotella
Cl. perfringens Spiral shaped rods

Lactobacillus Clostridium-other


2 3 4 5 6 7 8 9 10 11
Log no of bacteria /g feces

Human Fecal Microbiota determined

by Culture Method (Mitsuoka)
Health in intestinal tract

Intestinal tract
Choric acid

Liver - intestine cycle Modification

CA Choric acid

2nd. Cholate
Carcinogen ↓ CA
Blood cholesterol↓
LAB or Bifidobacteria
Colon cancer↓

Exostion out
6 % to total counts

% to total counts 4
30 3


20 B. fragilis C. clostridiiforme C. ramosum Bif. longum



B. vulgatus Bif adolescntis B. distasonis C aerofaciens B. thetaiotaomicron Pr. buccae
Comparison of relative prevalent bacteria in the
patients with colon cancer and healthy subjects
Healthy subjects
(by Bennno)
Colon cancer patients
Number of specimens detected



B. breve
B. bifidum
10 B. longum
B. adolescentis
Infants (70) Children (20) Adults (56) Aged persons(44)

Comparison of Fecal Bifidobacterium spp. on Advances in Age

( ) : No. of fecal specimen

(by Bennno)
carbohydrate polymers built up by repeated
condensations of monosaccharides (sugars), in this
case fructose units

Oligosaccharide :
a class of carbohydrates that consist of two to ten simple
sugar units joined together. Depending on the structure,
individual sugars may be cleaved off of the starting
compound by hydrolysis. see also fructooligosaccharide
Fiber :
dietary fiber is a complex mixture of plant
material that is resistant to digestion in the
human digestive tract. It can be a combination
of celluloses, hemicelluloses, pectins, gums
and lignins. See also soluble fiber, non-
soluble fiber.
Problems of FOSHU

Approval for products under the FOSHU

subcategory still requires the submission of
extensive data, similar to the requirements for
This makes the approval process time consuming
and burdensome.
FOSHU and probiotics

The Japanese spent $126 per person per year on

functional foods compared with $67.9 per person
per year in the US, $51.2 for Europeans and $3.20
(est.) for other Asians.

Probiotics is a large part of Japanese functional

foods. This report captures the $3.23 billion
probiotics product market
Thank you for your attention