PROPHYLACTIC USE OF INULIN AGAINST SINUSITIS

Abstract

The present invention relates to an inulin composition comprising GF.sub.n- and F.sub.m-compounds, in particular for decreasing the risk of sinusitis, preferably for use in the prophylaxis of sinusitis in a subject in need thereof and food, beverages and pharmaceutical compositions containing the inulin composition.

Claims

1. An inulin composition comprising GF.sub.n- and F.sub.m-compounds which composition comprises 25 to 40 wt.-% (dry matter, based on total mass of carbohydrates) of compounds having a DP11 (degree of polymerization), 15 to 30 wt.-% (dry matter, based on total mass of carbohydrates) of F.sub.m compounds with m=2 to 9, wherein the DP.sub.Av (average degree of polymerization) of the inulin composition is 6.5 to 9.

2. The inulin composition according to claim 1 for decreasing the risk of sinusitis in a subject in need thereof.

3. The inulin composition according to claim 2, wherein the risk of sinusitis is decreased by at least 33% in a group of subjects in need thereof compared to a group of placebo-treated subjects.

4. The inulin composition according to claim 1 for use in the prophylaxis of sinusitis in a subject in need thereof.

5. The inulin composition according to claim 2, wherein the subject in need thereof is a human at an age of at least three years.

6. The inulin composition according to claim 5, wherein the subject in need thereof is a human at an age from three to six years.

7. The inulin composition according to claim 1, which comprises 30 to 38 wt.-% (dry matter, based on total mass of carbohydrates) of compounds having a DP11.

8. The inulin composition according to claim 1, which comprises 20 to 28 wt.-% (dry matter, based on total mass of carbohydrates) of F.sub.m compounds with m=2 to 9.

9. The inulin composition according to claim 1, wherein the DP.sub.Av is 7 to 8.

10. The inulin composition according to claim 1, comprising 50 to 70 wt.-% GF.sub.n- and F.sub.m-compounds with a DP 3 to 10 and 30 to 40 wt.-% GF.sub.n-compounds with a DP11 (each based on dry matter and on total mass of carbohydrates).

11. The inulin composition according to claim 1, comprising 80 to 99 wt.-% GF.sub.n- and F.sub.m-compounds and 1 to 20 wt.-% monosaccharides and sucrose (each based on weight of dry matter and total mass of carbohydrates).

12. The inulin composition according to claim 1, wherein the composition is for use in a dosage from 5 to 15 g/per day for adults.

13. The inulin composition according to claim 1, wherein the composition is for use in a dosage from 2.5 to 15 g/per day for children.

14. The inulin composition according to claim 1, wherein the composition is for use over an administration period from 1 to 8 months.

15. A food, beverage or pharmaceutical composition comprising the inulin composition according to claim 1.

16. The inulin composition according to claim 4, wherein the subject in need thereof is a human at an age of at least three years.

17. The inulin composition according to claim 16, wherein the subject in need thereof is a human at an age from three to six years.

18. The inulin composition according claim 10, comprising 55 to 65 wt.-%, GF.sub.n- and F.sub.m compounds with a DP 3 to 10 and 35 to 39 wt.-%, GF.sub.n-compounds with a DP11.

Description

[0067] The present invention will now be further illustrated by way of a non-limiting example and the accompanying figures.

[0068] The figure shows:

[0069] the number of sinusitis episodes in children being subjected to a prophylactic treatment with the inulin composition of the present invention (termed prebiotic) and a placebo.

EXAMPLE

[0070] A) A double-blind, parallel, randomized and placebo controlled study on the effect of a prebiotic inulin composition according to the invention was conducted in children of 3 to 6 years. The study was conducted at the Nutritional Research Unit, investigated whether an administration of said mixture helps to reduce the risk of sinusitis episodes. The children took part in this study with the consent and permission of their parents.

[0071] From a group of 270 randomized children 258 started the study while 219 completed it with a group of 39 children which has dropped out. The children were healthy children of 3 to 6 years of age and were attending daycare centers.

[0072] The children were allocated to two different groups, wherein the first group (130 subjects) was subjected to a six-month administration of 6 g/day of the inulin composition of the present invention and the second group (128 subjects) (placebo group) was subjected to a six-month administration of 6 g/day of maltodextrin. The data were collected on five different study days (SD1 to SD5).

[0073] The prebiotic inulin composition and placebo were mixed into food and drinks consumed at a fixed time point each day (e.g. for breakfast or dinner).

[0074] The study design is depicted below.

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[0075] To detect differences between the two supplemented groups the following statistical tests were used:

[0076] Shapiro-Wilk test for normal distribution,

[0077] Mann-Whitney test for quantitative variables, anthropometric measurements and incidence and duration of infectious diseases,

[0078] Pearson Chi-square test for variables expressed as percentages and for comparison of the proportion of children with specific acute disease incidences and antibiotic prescription rates.

[0079] Statistical tests were performed two-sided. A p-value of less than 5% was considered as statistically significant.

[0080] The data as presented herein were obtained on 5 different study days (SD 1-5) as evident from the above study design.

[0081] B) The prebiotic inulin composition as used in the study had 27 wt.% of compounds having DP11, 26 wt.% of F.sub.m compounds (with m being 2 to 9), and a DP.sub.av of 7.5. These characteristics were determined as described above in sections A and B. The prebiotic inulin composition was prepared by mixing 93% highly soluble inulin (Orafti HSI, supplier: BENEO) with 7% long-chain inulin (Orafti HP, supplier: BENEO).

[0082] C) The figure compares the prevalence of sinusitis episodes in the group of children having obtained the present inulin composition and the placebo group. Accordingly, there is a significant reduction in the sinusitis prevalence by 77% in the groups of children having obtained the inulin composition of the present invention. The present study, therefore, shows that the number of sinusitis episodes (figure) could drastically be reduced by intake of the inulin composition of the present invention.

[0083] The present study conducted in 3 to 6-year-old children, thus, shows the modulation of the health status of children with respect to the reduction of sinusitis even though the development of the immune system should have been almost completed at said age. The major period of maturation of the immune system is the infantile age, namely 0 to 12 months. Hence, the prebiotic inulin composition of the present invention is able to improve the performance of the immune system in children of preschool age, which is a novel and advantageous finding. The present study is the first study showing a significant reduction of sinusitis episodes in children, in particular aged 3 to 6 years.

[0084] Summing up, the present study shows that the present inulin composition is effective in the modulation of sinusitis over a vulnerable seasonal period in highly exposed study population, namely children attending daycare facilities aged 3 to 6 years.