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.-18. (canceled)

19. A method for decreasing the risk of sinusitis, comprising the step of administering to a subject in need thereof an inulin composition comprising GF.sub.n- (Glucose-Fructose.sub.n-) and F.sub.m-(Fructose.sub.m-) compounds which composition comprises 25 to 40 wt.-% (dry matter, based on total mass of carbohydrates) of GF.sub.n- and F.sub.m-compounds having a DP≥11 (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.

20. The method according to claim 1, wherein administration of the composition to a group of subjects in need thereof decreases the risk of sinusitis by at least 33% compared to a group of placebo-treated subjects.

21. The method according to claim 1, wherein the subject in need thereof is a human at an age of at least three years.

22. The method according to claim 3, wherein the subject in need thereof is a human at an age from three to six years.

23. The method according to claim 1, the inulin composition comprising 30 to 38 wt.-% (dry matter, based on total mass of carbohydrates) of compounds having a DP≥11.

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

25. The method according to claim 1, wherein the DP.sub.AV of the inulin composition is 7 to 8.

26. The method according to claim 1, the inulin composition comprising GF.sub.n- and F.sub.m-compounds with a DP 3 to 10 in an amount 50 to 70 wt.-% and GF.sub.n-compounds with a DP≥11 in an amount of 30 to 40 wt.-% (each based on dry matter and on total mass of carbohydrates).

27. The method according to claim 8, the inulin composition comprising GF.sub.n- and F.sub.m compounds with a DP 3 to 10 in an amount of 55 to 65 wt.-% and GF.sub.n-compounds with a DP≥11 in an amount of 35 to 39 wt.-% (each based on dry matter and on total mass of carbohydrates).

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

29. The method according to claim 1, wherein the inulin composition is administered to adults in a dosage from 5 to 15 g/per day.

30. The method according to claim 1, wherein the inulin composition is administered to children in a dosage from 2.5 to 15 g/per day.

31. The method according to claim 1, wherein the inulin composition is administered to the subject in need thereof over an administration period from 1 to 8 months.

32. The method according to claim 1, wherein the inulin composition is administered to a subject in need thereof in the form of a food, beverage or pharmaceutical composition.

33. A method for prophylactically treating sinusitis, comprising the step of administering to a subject in need thereof an inulin composition comprising GF.sub.n- (Glucose-Fructose.sub.n-) and F.sub.m- (Fructose.sub.m-) compounds which composition comprises 25 to 40 wt.-% (dry matter, based on total mass of carbohydrates) of GF.sub.n- and F.sub.m-compounds having a DP≥11 (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.

34. The method according to claim 15, wherein the subject in need thereof is a human at an age of at least three years.

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

Description

EXAMPLE

[0073] 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. [0074] 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. [0075] 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). [0076] 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). [0077] The study design is depicted in FIG. 2.

[0078] To detect differences between the two supplemented groups the following statistical tests were used: [0079] Shapiro-Wilk test for normal distribution, [0080] Mann-Whitney test for quantitative variables, anthropometric measurements and incidence and duration of infectious diseases, [0081] 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.

[0082] Statistical tests were performed two-sided. A p-value of less than 5% was considered as statistically significant.

[0083] The data as presented herein were obtained on 5 different study days (SD 1-5) as evident from FIG. 2. [0084] B) The prebiotic inulin composition as used in the study had 27 wt. % of compounds having DP≥11, 26 wt. % of F.sub.m compounds (with m being 2 to 9), and a DPav 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). [0085] C) FIG. 1 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 (FIG. 1) could drastically be reduced by intake of the inulin composition of the present invention.

[0086] 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.

[0087] 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.