EP1903891A2

EP1903891A2 - Alimentary pasta enriched and supplemented with lutein

Info

Publication number: EP1903891A2
Application number: EP06766378A
Authority: EP
Inventors: Catia Biondi; Piero Biondi; Enrico Biondi; Chiara Biondi
Original assignee: Sooft Italia SpA
Current assignee: Sooft Italia SpA
Priority date: 2005-07-07
Filing date: 2006-07-07
Publication date: 2008-04-02
Also published as: WO2007007366A3; ITRM20050361A1; WO2007007366A2

Abstract

Described herein is an alimentary pasta supplemented with lutein usable for the prevention of the deficiency of said element and as adjuvant in the treatment of senile macular degeneration .

Description

ALIMENTARY PASTA ENRICHED AND SUPPLEMENTED WITH LUTEIN

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The present invention relates to the foodstuff sector and more precisely to an alimentary pasta supplemented with lutein.

The above-mentioned product can be used in the integration of nutrition in the prevention and as adjuvant in the treatment of pathological conditions linked to the deficit of said nutrient.

Known to the state of the art are different foodstuff specialities with targeted nutritive and/or organoleptic properties and in particular specialities with a base of dough mixes of durum-wheat flour with the addition of various ingredients (eggs, spinach, red peppers, etc.).

These foodstuff specialities coat a particular importance from a nutritive or integrative standpoint. Lutein is a nutrient indispensable to the human organism but is not synthesized thereby and must be assumed with the diet through different kinds of food, in particular with vegetables with large and numerous leaves, such as cabbages, spinach, etc. Lutein is important for preserving anatomic and functional integrity of the macula lutea of the eye, which represents the point where the images are received before being transmitted to the brain. This is consequently, in the case of the macula, a fundamental structure for the eyesight that is to be preserved in its functional integrity since it can undergo \a process of degeneration, particularly in old age, which can cause irreparable damage to eyesight. Lutein is a yellow-coloured natural pigment. Chemically it is an organic substance, carotenoid, with antioxidant activity. The physical state is solid, crystalline, yellow, and slightly hygroscopic. Lutein is found in nature in fruit and "green" and "yellowish-orange" vegetables. The major sources of lutein are leafy cabbages, spinach and all vegetables with dark- green leaves. Other sources are: mango, papaya, kiwi, peaches, plums, peas, broccoli, lettuce, and pumpkins. It is also present in the yolks of eggs.

Lutein is obtained by purification from the extract of marigold.

Lutein, introduced with foodstuffs or by means of administration of substance of extractive origin, is absorbed with the aid of bile and fats assumed with the diet. Incorporated in the chylomicrons it reaches, through the lymphatic pathways, the liver and from there, bound to lipoproteins, passes in the bloodstream. It is readily distributed to all the tissues. It passes through the haemato-encephalic and haema,to-retinic barrier. It accumulates principally in the retina (macula) , in the crystalline lens and in fatty tissue.

Lutein and zeaxanthin are found in human milk and in the umbelical chord so that the intake of said carotenoids by the mother affects the concentrations in the new-born.

It has a half-life of 11-14 days.

The main activities of lutein are:

- inhibition of peroxidation of membrane lipids;

- antioxidant activity; - inhibition of oxidative stress;

- antiradical activity with high scavenger effect (radical- trapping activity) ;

- quencing effect in regard to singlet and triplet oxygen;

- anti-inflammatory activity by inactivation of the reactive species of. oxygen; - stabilization of cell membranes by reinforcement of their structure;

- synergistic activity with other antioxidant substances present in the organism (vitamin⁴ E, vitamin C, etc.);

- induction of detoxicating enzymes; - promotion of antitumoural activity;

- improvement of the functions of the immune system owing to immuno-modulating action and increase of iramunocompetence;

- positive effect (up-regulation) on the proteins that regulate the transmission of information in the junction interstices; and

- reduction or inhibition, as other carotenoids, of mutagenesis and cell transformation (in vitro) .

On account of its protective characteristics in regard to oxidative and photochemical stress, lutein finds its chief use in the prevention b.nd retardation of senile macular degeneration and in other degenerative diseases of the eye.

Even though the recommended daily allowance (RDA) has not been established, it is deemed that a dose of between

10 and 20 mg per day is able to guarantee an effective preventive activity in regard to ^■ many degenerative diseases, in particular to those affecting the eye.

There have never been reported side effects or toxic effects, either at a gastro-intestinal level or a systemic level, after administration of lutein. In the last few years, there have been increasingly numerous studies and demonstrations that lutein and zeaxanthin, its isomer, nutrients belonging to the family of the carotenoids, can constitute a valid and important preventive and protective factor in regard to numerous chronic affections that involve millions of people throughout the world.

In nature, in the various vegetables that contain them, lutein and zeaxanthin are present in a stoichiometric ratio of 20:1, and likewise in the various extracts obtained from the corresponding vegetables.

Zeaxanthin represents a stereoisomer of lutein with continuous transformation from lutein to zeaxanthin and vice versa, according to the biological requirements of the tissue in which lutein and zeaxanthin are transported or accumulate. Otherwise, the pharmacokinetic and pharmacodynamic characteristics of the two substances are practically the same.

The protective effect of lutein on the heart has recently been described, and it has been shown that lutein is able to reduce the risk of heart disease.

Numerous scientific demonstrations confirm that lutein is able to reduce the risk of onset of senile macular degeneration (SMD) or to slow down its course. SMD represents the biggest risk of blindness in the world in subjects over fifty years of age and its prevalence among subjects over 65 years is 8% and increases with age.

Further studies have repoated a smaller incidence of the risk of onset of neoplasms (breast, lung and prostate) when the nutritional intake of lutein is particularly high. Owing to its specific characteristics, lutein has a high bioavailability after oral administration. The levels of lutein in the blood, after assumption of foodstuffs rich in carotenoids, increases by 67% as against 14% found for beta-carotene.

Negative or toxic effects have never been reported in humans after supplementation of lutein and zeaxanthin, either at a gastro-intestinal level or at a systemic level. Particularly felt in the foodstuff sector is the need to create specialities with purposes of integrating particular nutrients or micronutrients, which should be assumed normally with a multivariate diet but which, for reasons linked to a reduced assumption or to an increased requirement, become deficient, in order to create the pre- conditions for the maintenance of a balanced intake of nutritive elements useful to the organism.

In Italy one of the most important foodstuffs, which are traditionally at the basis of our diet and in general are consumed every day, is constituted by pasta. The integration of this foodstuff with lutein results in a reduction of the risk of pathological conditions linked to ageing of the cell and to the action of free radicals in so far as an adequate intake of lutein and zeaxanthin is guaranteed. Consequently, forming a subject of the present invention is an alimentary pasta whether of durum-wheat flour or of soft-wheat flour, or different mixtures thereof, kneaded with water or with the addition of egg, either fresh or lyophilized, said pasta being in its fresh form or as dry product and containing lutein. It has been verified that the temperature of cooking of the alimentary pasta is lower than the temperature of degradation of lutein and zeaxanthin (375°F). Consequently, the bioavailability of the two components remains unaltered in the alimentary pasta forming the subject of the invention, up to final consumption thereof.

According to a peculiar 'characteristic of the present invention, lutein is not added in its purified form, which is crystalline, but rather using an oily vehicle, which amalgamates well with the alimentary pasta during its preparation, such as safflower oil, which contains 20% of lutein and 0.8% of its stereoisomer zeaxanthin, or in the form known commercially as "FloraGLO", obtained according to what^' is described in the patent No. WO/9723436, or other preparations of lutein adequate for mixing lutein itself with durum-wheat flour or soft -wheat flour.

The composition forming the subject of the present invention comprises, for 100 g of alimentary pasta, a variable amount of lutein not greater than 40 mg and of zeaxanthin not greater than 1.6 mg.

In the preferred examples of embodiment, the alimentary pasta is made up, for 100 g of (dry) end product, of: 1. Pasta with egg - a mixture of durum-wheat flour and eggs in a percentage of 87.48%, (of which durum-wheat flour represents 72.44%, or 63.38 g, and pasteurized fresh eggs 27.54%, or 24.10 g) ; - safflower oil (containing 20% of lutein and 0.8% of zeaxanthin, corresponding to an amount of lutein of 4 mg and of zeaxanthin of 0.16 mg, or 0.02 g; (relative humidity 12.5%.) 2. Pasta made of durum-wheat flour

- Durum-wheat flour in an amount corresponding to 87.48% (carbohydrates 72-74%, proteins 12-14%, fats 1.6%);

- safflower oil in an amount corresponding to 0.020% (containing 20% of lutein and 0.8% of zeaxanthin, 4 mg of lutein and 0.16 mg of zeaxanthin for 100 g of end product) (Relative humidity 12.5%).

Claims

1. An alimentary pasta, whether fresh or dry, comprising for 100 g of end product, an amount of lutein not greater than 40 mg and of zeaxanthin not greater than 1.6 mg.

2. The alimentary pasta according to Claim 1, characterized in that lutein and zeaxanthin are added using an oily vehicle or other vehicle of lutein suitable for mixing with the flour.

3. The alimentary pasta according to Claim 2, characterized in that the oily vehicle is safflower oil.

4. The alimentary pasta having the following composition for 100 g of end product:

- mixture of durum-wheat flour and eggs 87.48%

- safflower oil 0.020% (containing 20% of lutein and 0.8% of zeaxanthin, 4 mg of lutein and 0.16 mg of zeaxanthi-n for 100 g of end product) and with a relative humidity of 12.5%.

5. The alimentary pasta having the following composition for 100 g of end product: - wheat flour (hard and/or soft) 87.48%

- safflower oil 0.020% (containing 20% of lutein and 0.8% of zeaxanthin, 4 mg of lutein and 0.16 mg of zeaxanthin for 100 g of end product) and with a relative humidity of 12.5%.