Resubmission of a health claim on functional foods related to non-digestible oligo and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin and increase in calcium absorbtion

1. HEALTH CLAIM RELATED TO ‘NON-DIGESTIBLE OLIGO-AND
POLYSACCHARIDES INCLUDING GALACTO-
OLIGOSACCHARIDES, OLIGOFRUCTOSE, POLYFRUCTOSE
AND INULIN’ AND ‘INCERASE IN CALCIUM ABSORPTION’.
Mamata Bhattarai
Bobby Antan Caiquo
Michael Amoafo Mensah

2. Health claim request
• Food constituents- Non digestible oligosaccharides and
polysaccharides including galacto-oligosaccharides,
oligofructose, polyfructose and inulin
• Health claim- Increase in Ca absorption
• Target population- infants (from birth onwards) and young
children (up to three years of age)
• Food- infant and follow on formula and processed cereal based
food

3. Reasons for refusal of application
• Food ingredients not sufficiently characterized
• Cause and effect relationship could not be established
between consumption and beneficial health effect

4. Health claim
• According to EU regulation, 1924/2006, a health claim is any
claim that suggests or implies that a relationship exists
between food category, a food or one of its constituents and
health.
• Consumption of food category, a food or one of its constituents
would lead to
• Improve heath and well being
• Reduction of diseases
• Child development and health

5. Claim requirements by EU directive
• Possible to add other substances, which have particular
nutritional purpose in infant and follow-on formula and cereal
based processed foods for younger children up to 3 years.
Directive 2006/141/EC

6. What are prebiotics?

7. Prebiotics (contd..)
• Non-digestible oligosaccharides (NDOs)- low molecular weight
carbohydrates- immediate in nature between simple sugars
and polysaccharides
• Can be made of one, two or even three different types of
monosaccharide units
• Most investigated substances compared to probiotics and
synbiotics

8. Non-digestible carbohydrates
• Galactooligosaccharides (GOS), or Trans-
galactooligosaccharides (TOS)
• Oligosaccharides composed of galactose units,
• DP ≤10, an average DP of 2-6.
• Preferably, GOS contains at least 2/3 galactose units
• ‘Fructooligosaccharide, or oligofructose’
• Soluble dietary fiber comprising a chain of β linked fructose units
• Degree of polymerisation ≤ 10
• Also used as alternative sweetner
• Inulin and polyfructose
• Glucose-terminated fructose chains with at least 90%-95% having DP≥10
• Industrially, it is mostly extracted from chicory

9. Factors affecting Ca absorption and bioavailability
• Effective calcium absorption- active and passive diffusion in
intestine
• Presence of SCFAs is prerequisite for stimulation of Ca absorption
in human (Trinidad et al., 1993)
• Many minerals like Ca chelated by pectin from fiber components
are freed in colon
• Cell membranes have lower permeability to high charged ions like
calcium
• Organic acids like SCFAs form charged mineral complexes which
helps in passive diffusion of these complexes
In his study, addition of SCFA
enhanced the Ca absorption in
distal colon in 6 healthy males

10. Mechanisms of Ca absorption - enhanced by
prebiotics
• Increased solubility of minerals due to bacterial production of
SCFAs
• Enlargement of absorption surface by promoting proliferation of
enterocytes mediated by bacterial fermentation products
• Degradation of mineral complexing phytic acid
• Increased expression of calcium-binding proteins
• Release of bone-modulating factors such as phytoestrogens from
foods
• Stabilization of intestinal flora and ecology
• Stabilization of intestinal mucus and impact of growth modulating
factors such as polyamines

11. NDOs with variable DP
• Synergistic effects - combination of inulin and
fructooligosaccharides (FOS) or FOS with various DP
• Mixture of different chain lengths- assumed to be fermented
sequentially and thus over a wider range of large intestine and
with improved efficacy (Scholz-Ahren et al., 2007).

12. Prebiotics in infant nutrition
• Prebiotics carbohydrates have been added to infant formula in
Japan for over 20 years
• 90% of infant formula in Japan are purported to contain
prebiotics.
• Process of commercialization going on in Europe and US
• Beneficial role of prebiotics in infants diets has been proven in
many studies.

13. Prebiotics role in infant nutrition
• Human gut micro flora is very complex.
• At birth, infants intestine are almost
sterile
• Intestinal micro flora does not change
significantly after infancy.
• Infants early diet and intestinal micro
flora pivotal factors in overall health and
development

14. Prebiotics and SCFAs
• Stools from breast fed infants
and formula fed infants were
collected and HMOS or
GOS/FOS were added and
incubated for 24h.
• Short chain fatty acids were
detected.
• Bifidobacteria, lactobacillus,
acetic acid was stimulated in
GOS (2.4g/l) formula fed 371
infants, fecal pH was
decreased (Cai et al, 2008) Production of different SCFA during in-vitro fermentation of 2 test substances,
human milk oligosaccharides (HMOS) and mixture of GOS/FOS compared to
control without oligosaccharides. Adapted from Boehmn et al., 2004

15. Prebiotics and infant health
Improved Ca
absorption
Improved Ca
absorption

16. Substances
Amount
g/d
Calcium
absorption
Subject of
study
Comment Method References
Inulin 40 sig Young men
Metabolic
Balance
Coudray et al, 1997
OF 15 sig
12
Adolescents
(14-16y)
36h urine coll. Stable isotope Van den Heuvel et al, 1999
TOS 20 sig POM (12) 36h urine coll. Stable isotope Van den Heuvel et al, 2000
OF 8 ns Girls (30) 48h urine coll. Stable isotope Griffin et al, 2002
OF+inulin 8 sig Griffin et al, 2002
Sc and lc FOS mix 8 sig
Boys and girls
(48)
48h urine coll. Stable isotope Abrams et al, 2005
GOS+FOS 8 sig
Adolescents
girls (61) 12hr fast Serum ionized Ca
Sanwalka et al, 2002
Oligofructose
15
sig
Adolescents
male (12) 36h urine coll. Stable isotope
Ellen et al, 1999
TOS 20 sig
Post
menopausal
women
36h urine coll. Stable isotope Ellen et al, 2000
Results from human studies
OF-Oligofructose, TOS-Transgalacto-oligosaccharides, Sc/lc FOS- shortchain/longchain fructo-oligosaccharides

17. Possible reasons for inconsistent and
inadequate results
• Habitual intake of NDO cannot be easily controlled in human
studies
• More studies have been performed in animal model,
experimental conditions difficult to control in human
• Ethical reason- difficult to conduct studies in
infants/children/human
• Experimental design, efficacy depends on dose, time of
administration, content of calcium in diet, age of subjects
studied
• Effect is specific for type of carbohydrate and calcium
absorption capacity

18. Conclusion
• Adverse effect of NDOs and others has not been reported in
scientific literature.
• Synergistic effects among different NDOs and NDOs with
different DP was observed
• Literature suggesting enhancement of Ca absorption by NDOs
and polysaccharides cannot be ignored
• Based on these facts, our health claim should be reconsidered
by EFSA