Note: Descriptions are shown in the official language in which they were submitted.
- 1 _
The present invention relates to the
domain of dietetics. It relates in particular to the
domain of food for pregnant or breast-feeding women.
A particular subject of the invention is
nutritional supplements for pregnant or breast
feeding women characterized in that they are
constituted by a plant source of di-, tri- or tetra
unsaturated fatty acids of the n-6 series and the n
3 series, which are added to or mixed with one or
more inert liquid or solid food supports, allowing
administration in a dosed form.
Preferably, the plant source of di-, tri-
or tetra-unsaturated fatty acids is constituted by
an oil rich in such acids such as for example an oil
from seeds of the Ribes species, such as
blackcurrant seed oil, redcurrant seed oil or
gooseberry seed oil.
Concentrates of these fatty acids can also
be used as has been shown in the French Patent
2,637,910, in which the extraction of Ribes seeds
with supercritical fluid and fractional separation
of the different fractions of fatty acids are
described.
The oils from fruit seeds of the Ribes
species differ clearly from other plant oils such as
evening primrose oil (Oenothera lamarckiana) or
borage oil (Borrago sp.) which contain a small
amount of alpha-linolenic acid (18 n-3), very little
stearidonic acid (18:4 n-3) and a lot of y-linolenic
acid.
Also according to the same criteria, the
oils of Ribes seeds can be differentiated from other
plant oils (rapeseed, nut, Soya, linseed) which only
contain as essential fatty acids, linoleic acid
(18:3 n-6) and alpha-linolenic acid (18:3 n-3).
This is why the oils of Ribes seeds have
the great advantage of containing, in addition to
- 2 - 2152153
the two essential fatty acids of the n-6 and n-3
series (linoleic and alpha-linolenic), the two
higher homologous fatty acids (y-linolenic acid and
stearidonic acid), such that the cost of the 06-
desaturase route is lightened, whereas this
intervention is often a limiting factor in the
synthesis of long-chain polyunsaturated fatty acids
such as arachidonic acid (20:4 n-6) and
docosahexaenoic acid (DHA or 22:6 n-3).
The presence of a large quantity of
polyunsaturated fatty acids of the n-3 series (from
to 35~), therefore gives the oils of Ribes seeds
dietetic advantages that the other oils do not have.
In fact, the nutritional needs of pregnant
15 women or breast-feeding women are quite specific
since they must on the one hand allow the foetus to
develop, and on the other hand provide a suitable
composition for the mothers's milk.
These supplies have been widely studied in
terms of calorific value, provision of basic
nutriments (lipids, protids, glucides), provision of
mineral salts and provision of trace elements.
However, more recent data has made it
possible to state that up to now, the specific
essential fatty acid requirements of very young
children was not very well known and this lack of
knowledge was likely to lead to states of deficiency
in newborn babies.
It has been possible to prove, in
particular, that in order to ensure the development
of the brain, the child needs a sufficient supply of
arachidonic acid (C20:4 n-6) and of docosahexaenoic
acid (DHA C22:6 n-3). These two essential fatty
acids are necessary for the brain, that is to say
that a deficiency generates lesions and retardation
at the level of the development of the cognitive
functions, sight and hearing (Crawford M. Am. J.
- 3 -
2152153
Clin. Nutr. (1993) 57(suppl.) p.703-710; Koletko B.
Europ. J. Clin. Nutr. 46(suppl.l) p.51-52).
In order to provide a sufficient supply of
these two fatty acids at the level of the placenta
for the foetus, and in the mother's milk for the
unweaned infant, the mother must find, in her food,
a correct and balanced supply of their metabolic
precursors:
- linoleic acid
- 'y-linolenic acid
- alpha-linolenic acid
- stearidonic acid
Now, this supply, if it is of sufficient
quality, is often unbalanced by an excess of
linoleic acid (Clg:2 n-6) which is found in
abundance in commercial vegetable oils such as corn
or sunflower oil. This excessive consumption of a
Clg:2 n-6 acid can lead to the inhibition, by a
significant factor (of the order of 4), of the
conversion of this acid into higher fatty acids.
Also, in the presence of such an excess, the
conversion of the Clg:3 n-3 acids is reduced by a
factor of 3 (Guesnet Ph. Cahier Nutr. Diet. XXVIIII
Vol. 1 (1993) p. 19-25).
Consequently, too high a consumption of
sunflower oil or corn oil can lead paradoxically to
a deficiency of arachidonic acid and DHA in foetuses
and in unweaned infants which are being breast-fed.
In addition, it has been determined that
it is during the first few weeks of embryogenic
development that the divisions of the nerve cells
are the most intense and that the needs of the
foetus's brain are the greatest. These are points in
favour of the dispensing to pregnant women of food
supplements from the start of gestation, and even
from the time they decide they want to become
mothers.
4
A recent study, carried out in FRANCE,
enabled the milk of 41 women spread over three
regions of FRANCE to be analyzed (Durand G., Europ.
J. Clin. Nutr. in press). This study reveals that
the milk of French women is relative lacking in
Clg:3 n-6 acids (0.6~ fatty acids) but is relatively
over rich in Clg:2 n-6 acid (13~).
The ratio Clg:2 n-6
Clg:3 n-6
is of the order of 20, that is to say among the
highest in WESTERN EUROPE.
Therefore, the provision of a nutritional
supplement of specific fatty acids to pregnant women
or to breast-feeding women seems to be highly
desirable.
Among the plant oils currently available
on the market, it appears that the oils obtained
from Ribes fruit seeds have a useful fatty acid
content. There can be mentioned in particular
gooseberry seeds (Ribes uva crispa), blackcurrant
seeds (gibes nigrum) and redcurrant seeds (gibes
rubrum) .
The seeds of these fruits contain about
20~ of oil which is rich (25~) in polyunsaturated
fatty acids of the n-6 and n-3 series.
In this case, redcurrant seed (gibes
rubrum) oil is
n- 6
preferred, which has a better n-3 ratio
close to 1.4 whereas this ratio is of the order of 4
for blackcurrant seed (gibes nigrum) oil.
However, a mixture of two or more oils can
also be used.
The simultaneous presence of alpha-
linolenic and stearidonic acids is of prime
importance since they are the preferred precursors
CA 02152153 2002-04-29
of docosahexaenoic acid which is essential for the
development of the central nervous system.
Therefore, the present invention relates
to nutritional supplements containing an effective
quantity of at least one Ribes seed oil, mixed with
or added to an inert support or vehicle, intended
for pregnant women or for breast-feeding women, in
order to favour cerebral maturation in a
physiological manner.
The present invention also relates to a
process for the production of a nutritional
supplement for pregnant or breast-feeding women,
having a high content of polyunsaturated fatty acids
of n-6 and n-3 series and a low content of mono- or
di-unsaturated fatty acids of n-6 series. The
process of the invention comprises mixing a fraction
or a concentrate of Ribes seed oil containing
polyunsaturated fatty acids of n-6 series and n-3
series in a n-6/n-3 ratio between 1.4 and 4, with a
physiologically acceptable vehicle.
In the supplements according to the
invention, the Ribes seed oils are dispersed or
included in an inert mineral support which enables
these supplements to be obtained in the form of
powders, granules or bars. The oil can also be
dispersed in an aqueous vehicle in the form of an
oil-in-water or water-in-oil emulsion by the
addition of a suitable surfactant. In this way
aromatized or non-aromatized milks, micro-emulsions,
and dispersions can be formed. The oils can also be
formulated in the form of liposomes by dissolving
the oil in an organic solvent non-miscible in water,
which has lecithin or cholesterol added to it, then
by dispersing it in water.
The solvent is evaporated to obtain a thin
film which is taken up in an aqueous medium
containing a non-ionic surfactant and agitation is
CA 02152153 2002-04-29
- 5a -
carried out until a homogeneous emulsion is formed.
After production of such an emulsion and
verification of its stability, the emulsion can be
diluted with an additional quantity of water.
5 The pulverulent forms can be aromatized,
sweetened, have a gelatinizing agent and/or a
binding agent and/or an inert diluting agent added
to them in order to produce a perfectly fluid
preparation.
10 For the stability of such preparations,
stabilizing agents and in particular anti-oxidizing
agents can be added to them.
- 6 -
2152i53
The preparations thus produced can, in
addition, have vitamin factors added to them such as
vitamin E, folic acid, vitamin B12 and/or mineral
salts such as iron in order to make up for certain
specific deficiencies in pregnant or breast-feeding
women.
For the convenience of ingestion, the
pulverulent preparations are packaged in gelatin
capsules containing 200 to 600 mg of Ribes fruit
seed oils, diluted in an inert food excipient or
diluting agent.
The following examples illustrate the
invention without however limiting it:
EXAMPLE I
- Redcurrant seed oil 250 g
- Alpha-tocopherol 0.5 g
- Bentonite 6 g
- Calcium carbonate 12 g
- Tricalcium phosphate 12 g
- Microcrystalline cellulose 18 g
- Talc 1.5 g
for 1000 gelatin capsules with an average
weight of
0.300 g.
EXAMPLE II
- Redcurrant seed oil 400 g
- Autolysate of brewer's yeast 6 g
- Colloidal silica marketed under the
trademark Aerosil 200 25 g
- Alpha-tocopherol 0.75 g
- Calcium carbonate 5 g
- Ferrous gluconate 8.25 g
- Carbomer sold under the trademark
Carbopol 934 4 g
- Water 60 g
for 1000 soft capsules with an average
weight of
0.500 g.
EXAMPLE III
.
- ~ _
2152153
- Blackcurrant seed oil 40 g
- Copolymer of ethylene oxide and
propylene oxide marketed under the
trademark Pluronic F18 20 g
- Autolysate of brewer's yeast 6 g ,
- Ascorbyl palmitate 0.5 g
- Calcium carbonate 5 g
- Ferrous gluconate 4.5 g
- Manganese gluconate 2.5 g
- Cobalt gluconate 2.5 g
- Polyethyleneglycol stearate 5 g
- Purified water sqf 1000 ml of emulsion
10 ml of emulsion corresponds to 0.400 g of
blackcurrant seed oil.
EXAMPLE IV
- Redcurrant seed oil (or failing this
blackcurrant seed oil) 50 g
- Folic acid 0.5 g
- Vitamin B12 0.06 g
- Ferrous ascorbate 1.50 g
- Vitamin E 0.25 g
- Polyethyleneglycol stearate 5 g
- Purified water sqf 1000 ml
1 ml of emulsion corresponds to 0.050 g of
redcurrant seed oil (or failing this blackcurrant
seed oil) .
