2.1. Zmiany w funkcjonowaniu jelit (skrócenie czasu pasażu jelitowego, zwiększenie częstości ruchów jelit, zwiększenie objętości stolca) (ID 825)

The claimed effect is “gut health”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to changes in bowel function.
The Panel considers that changes in bowel function such as reduced transit time, more frequent bowel movements, increased faecal bulk or softer stools may be a beneficial physiological effect, provided these changes do not result in diarrhoea.

2.2. Ograniczenie wzrostu stężenia glukozy (glikemii) po posiłku (ID 826)

The claimed effect is “carbohydrate metabolism and insulin sensitivity”. The Panel assumes that the target population is individuals wishing to reduce their post-prandial glycaemic responses.
In the context of the proposed wordings, the Panel assumes that the claimed effect relates to the reduction of post-prandial glycaemic responses.
Postprandial glycaemia is interpreted as the elevation of blood glucose concentrations after consumption of a food and/or meal. This function is a normal physiological response which varies in magnitude and duration, and which may be influenced by the chemical and physical nature of the food or meal consumed, as well as by individual factors (Venn and Green, 2007). Reducing post-prandial blood glucose responses may be beneficial, for example, to subjects with impaired glucose tolerance as long as post-prandial insulinaemic responses are not disproportionally increased. Impaired glucose tolerance is common in the general population of adults.
The Panel considers that a reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) may be a beneficial physiological effect.

2.3. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 827)

The claimed effect is “cardiovascular system”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal blood LDL-cholesterol concentrations.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries. Elevated LDL-cholesterol, by convention >160 mg/dL (>4.14 mmol/L), may compromise the normal structure and function of the arteries.
The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.

3.1. Zmiany w funkcjonowaniu jelit (skrócenie czasu pasażu jelitowego, zwiększenie częstości ruchów jelit, zwiększenie objętości stolca) (ID 825)

The references provided for the substantiation of the claim included two textbooks, one guideline document, one human study and one animal study, all of which reported on health outcomes unrelated to the claimed effect (e.g. faecal bile acids and formation of intestinal polyps). One reference was an abstract from a conference proceeding which did not provide sufficient information for a full scientific evaluation, and one reference on a human study was not accessible to the Panel after every reasonable effort had been made to retrieve it. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
A randomised, cross-over intervention study conducted in 28 overweight men investigated the effect on faecal weight of consuming foods (90 g) which contained either whole-grain rye flour or whole-grain wheat flour and provided about 21 g/day of dietary fibre vs. consuming refined cereal foods which provided 6 g/day of dietary fibre, for four weeks (McIntosh et al., 2003). Total 24 h faecal weight after consumption of high rye fibre foods was significantly higher than after consumption of low-fibre refined cereal foods (mean ±SEM=278±16 g vs. 203±18 g, p<0.005).
In a randomised, cross-over study, Gråsten et al. (2000) compared the effect of a whole-meal rye bread diet vs. a wheat bread diet in 17 healthy volunteers (nine women). Both interventions lasted four weeks. Subjects were advised to eat a minimum of 20 % of their total daily energy intake in the form of the tested breads. The intake of total dietary fibre from the tested products was estimated as 17.4±2.1 g/day for the rye bread period and 3.9±0.9 g/day for the wheat bread period. Wet and dry faecal weight, faecal frequency and intestinal transit time measured by a radiopaque method were evaluated. Differences between interventions were assessed by the Wilcoxon signed-ranks test. The results were presented separately for women and men. Compared to the wheat bread diet, the whole- meal rye bread diet significantly increased faecal weight (women 203±58 vs. 151±63 g/day, p<0.05; men 335±921 vs. 198±61, p<0.05) and faecal frequency (women 1.2±0.4 vs. 0.9±0.4 times per day, p<0.05; men 1.6±0.6 vs. 1.4±0.6 times per day, p<0.05), and significantly shortened intestinal transit time (women 44.8±13.1 vs. 56.2±22.0 hours, p<0.05; men 30.9±12.1 vs. 39.4±15.6 hours, p<0.05), in both women and men.
In a randomised, parallel study, Hongisto (2006) evaluated the effect of rye bread (containing 12.3 g fibre/100 g) with or without the bacterial strain Lactobacillus rhamnosus GG (LGG, ATCC53103) vs. low-fibre toast (control) on bowel function in a group of 59 women with self-reported constipation (mean age 41 years). Rye bread provided 37 g/day of dietary fibre, while low-fibre toast provided 6.6 g/day. During the three-week dietary intervention, the frequency of bowel movements was significantly higher in the rye bread group (n=15) compared to the control group (n=15) (mean difference 0.3 defecations/day, CI 95 % 0.1 to 0.5, p<0.001). Total intestinal transit time (measured by radiopaque method) was significantly shorter in the rye bread group than in the low-fibre toast group (mean difference = -0.7 days, CI 95 % -1.1 to -0.2, p=0.007).
Gråsten et al. (2007) in a randomised, cross-over study in 39 post-menopausal women with hypercholesterolaemia (mean age 59 years) administered rye bread with high fibre content (approximately 17 %) and white wheat bread with low fibre content (approximately 2.8 %) at doses covering at least 20 % of daily energy intakes for eight weeks each, with an eight-week wash-out period in between. The Wilcoxon test with Bonferroni adjustments was used for comparisons between the two intervention periods. The mean fibre intake in the rye bread period was 21.5 g/day higher than in the white wheat bread period (47±9 and 15±4 g/day during the rye bread and the white wheat bread periods, respectively). Frequency of defecation was significantly higher during the rye bread period than during the white wheat bread period (11.3±2.7 vs. 8.5±2.1 times per week, p<0.05). The proportion of soft stools was significantly higher and the proportion of hard stools was significantly lower during the rye bread period than during the white wheat bread period (p<0.05).
The Panel notes that the mechanism by which rye fibre could exert an effect on faecal weight, transit time and stool consistency is known and relates to an increase in water holding capacity of the content of the intestine.
In weighing the evidence, the Panel took into account that the results of all four human intervention studies considered showed an effect of rye fibre on various outcome measures related to bowel function. The Panel also noted the known mechanism by which rye fibre exerts the claimed effect.
The Panel concludes that a cause and effect relationship has been established between the consumption of rye fibre and changes in bowel function.

3.2. Ograniczenie wzrostu stężenia glukozy (glikemii) po posiłku (ID 826)

The references provided for the substantiation of the claim included one human intervention study which reported on health outcomes other than the claimed effect (e.g. bowel function); human intervention studies conducted in insulin-dependent diabetic patients or in ileostomy patients with ulcerative colitis; human intervention studies on post-prandial glycaemic and insulinaemic responses
to whole foods in which either the amount of rye fibre was not reported or a certain amount of rye fibre in bread was compared to the same amount of, for example, wheat fibre, and thus did not allow conclusions to be made on the effects of rye fibre per se; and human intervention studies in healthy subjects which did not assess post-prandial blood glucose responses following consumption of rye fibre, but rather the effects of longer-term consumption of rye fibre-containing food products on glucose tolerance (i.e. using the frequently sampled intravenous glucose tolerance test or the oral glucose tolerance test). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Three intervention studies provided investigated the effects of rye fibre in rye products on post- prandial blood glucose and insulin responses (Juntunen et al., 2002; Juntunen et al., 2003; Leinonen et al., 1999).
In the study by Leinonen et al. (1999), the effects of wheat bread (61 g available carbohydrates; 2.3 g fibre), whole kernel rye bread (55 g available carbohydrates; 13.5 g fibre), wholemeal rye bread (43 g available carbohydrates; 10.1 g fibre) and wholemeal rye crispbread (45 g available carbohydrates; 12.1 g fibre) consumed with a standard breakfast were compared with respect to induced post-prandial glucose and insulin responses (measured every 30 min for three hours, and at 15 min post-prandial) in 20 subjects (10 female) with normal glucose tolerance using a randomised cross-over design. Direct comparisons were made between wheat bread and whole kernel rye bread (two types of cereals), and between wholemeal rye bread and wholemeal rye crispbread (two types of rye bread). The Panel considers that only the first comparison is appropriate for the scientific substantiation of the claim. No significant differences in post-prandial blood glucose responses at any time point, or measured as areas under the curve, were observed between wheat bread and whole kernel rye bread. Insulin concentrations were significantly lower at 45 (p=0.025), 60 (p=0.002), 90 (p=0.0004), 120 (p=0.05) and 150 (p=0.033) min after the whole kernel rye bread than after the wheat bread (p=0.002 for the area under the curve). The Panel notes that this study did not show an effect of rye fibre on post- prandial glycaemic responses.
In the study by Juntunen et al. (2002), the effects of wheat bread made from white wheat flour (3.1 g fibre), whole kernel rye bread (12.8 g fibre), wholemeal pasta (5.6 g fibre) and wholemeal rye bread containing oat beta-glucan concentrate (17.1 g fibre) were compared with respect to induced post-prandial glucose and insulin responses (measured every 30 min for three hours and at 15 min post-prandial) using a randomised cross-over design and standard portions containing 50 g of available carbohydrates for all test foods. Subjects were 20 healthy men and women (mean age 28±1 years; BMI 22.9±0.7 kg/m2). The Panel notes that wholemeal rye bread containing oat beta- glucan concentrate cannot be used to address the effects of rye fibre, and that wheat bread is more appropriate than pasta to test the effects of rye fibre in whole kernel rye bread on post-prandial blood glucose responses. No significant differences in post-prandial blood glucose responses at any time point, or measured as areas under the curve, were observed between wheat bread and whole kernel rye bread. A significant decrease in post-prandial insulinaemic responses was observed after consumption of the whole kernel rye bread compared to the wheat bread (p<0.05). The Panel notes that this study did not show an effect of rye fibre on post-prandial glycaemic responses.
In the study by Juntunen et al. (2003) the effects of wheat bread made from white wheat flour (2.7 g fibre), endosperm rye bread (6.1 g fibre), traditional rye bread (15.2 g fibre) and high-fibre rye bread (29.0 g fibre) were compared with respect to induced post-prandial glucose and insulin responses (measured every 30 min for three hours, and at 15 min post-prandial) using a randomised cross-over design and standard portions containing 50 g of available carbohydrates for all test foods in a random order. Subjects were 19 healthy post-menopausal women aged 61±1 years and with a BMI of 26.0±0.6 kg/m2. No differences in post-prandial blood glucose responses (measured as maximal response or as incremental areas under the curve) were observed between wheat bread and the different rye breads. A significant decrease in post-prandial insulinaemic responses was observed
after consumption of the endosperm rye bread and the traditional rye bread compared to the wheat bread (p<0.05). No significant difference was observed between the high-fibre rye bread and the wheat bread. The Panel notes that this study did not show an effect of rye fibre on the reduction of post-prandial glycaemic responses. In weighing the evidence, the Panel took into account that the three human intervention studies provided from which conclusions could be drawn for the scientific substantiation of the claim did not show an effect of rye fibre on post-prandial glycaemic responses.
The Panel concludes that a cause and effect relationship has not been established between the consumption of rye fibre and reduction of post-prandial glycaemic responses.

3.3. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 827)

The references provided for the substantiation of the claim included textbooks, a meta-analysis and a review paper on the consumption of wholegrain foods and cardiovascular disease, a meta-analysis on the effect of oat products on blood lipids, a review on viscous fibres, and human intervention studies in ileostomy patients with ulcerative colitis. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
One randomised, cross-over study in humans was provided which investigated the effects of rye fibre on blood cholesterol concentrations (Leinonen et al., 2000). A total of 30 subjects (22 women) consumed rye and wheat breads (20 % of energy intake) for four weeks each with a four-week wash-out period in between. Men consumed on average 219 g of rye bread daily containing 22.1 g fibre (vs. 4.7 g/day fibre from wheat bread), and women 163 g of rye bread daily containing 16.4 g fibre (vs. 3.6 g/day fibre from wheat bread). The estimated daily amounts of beta-glucan were 2 g/day in men and 1.5 g/day in women. Data were analysed separately for men and women. No significant changes in total, LDL- or HDL-cholesterol concentrations were observed during the rye bread intervention compared to the wheat bread intervention. The Panel notes that this study did not show an effect of rye fibre consumption on blood cholesterol concentrations.
In weighing the evidence, the Panel took into account that the only human intervention study provided from which conclusions could be drawn for the scientific substantiation of the claim did not show an effect of rye fibre on blood LDL-cholesterol concentrations.
The Panel concludes that a cause and effect relationship has not been established between the consumption of rye fibre and maintenance of normal blood LDL-cholesterol concentrations.

4.1. Zmiany w funkcjonowaniu jelit (skrócenie czasu pasażu jelitowego, zwiększenie częstości ruchów jelit, zwiększenie objętości stolca) (ID 825)

The Panel considers that the following wording reflects the scientific evidence: “Rye fibre contributes to normal bowel function”.

5.1. Zmiany w funkcjonowaniu jelit (skrócenie czasu pasażu jelitowego, zwiększenie częstości ruchów jelit, zwiększenie objętości stolca) (ID 825)

The Panel considers that in order to bear the claim a food should be at least “high in fibre” as per Annex to Regulation (EC) No 1924/2006. The target population is the general population.