2.1. Utrzymanie prawidłowego funkcjonowania jelit (ID 812)

The claimed effect is “bowel function”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to aspects of maintaining bowel regularity and normal bowel function. Changes in bowel function within the normal range e.g. reduced transit time, increased frequency of bowel movements or bulk of stools might be interpreted as improvement of bowel function.
The Panel considers that maintenance of normal bowel function might be a beneficial physiological effect.

2.2. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 814)

The claimed effect is “uniform blood sugar levels”. The Panel assumes that the target population is individuals willing to reduce their post-prandial glycaemic responses.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to a 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 is a normal physiological response that varies in magnitude and duration and 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). The evidence provided does not establish that decreasing post-prandial glycaemic responses in subjects with normal glucose tolerance is a beneficial physiological effect. However, it may be beneficial 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 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 we krwi (ID 815)

The claimed effect is “maintenance of normal cholesterol levels”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance of normal blood 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. High-density lipoproteins (HDL) act as cholesterol scavengers and are involved in the reverse transport of cholesterol in the body (from peripheral tissues back to the liver).
The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.

2.4. Zwiększenie sytości prowadzące do redukcji przyjmowanej energii (ID 2933)

The claimed effect is “satiety”. The Panel assumes that the target population is the general population.
Satiety is the decrease in the motivation to eat after consumption of food. The effect may persist up to
several hours, may reduce energy intake either at the next meal or across the day and, if sustained, may lead to a reduction in body weight.
The Panel considers that an increase in satiety leading to a reduction in energy intake, if sustained, might be a beneficial physiological effect.

3.1. Utrzymanie prawidłowego funkcjonowania jelit (ID 812)

Four references were cited to substantiate the claim. One was a technical report and three were references to regulatory frameworks. None of these references are related to HPMC. The Panel
considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of HPMC and maintenance of normal bowel function.

3.2. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 814)

Nine references were cited to substantiate the claim. Some references investigated the effects of food constituents other than HPMC (e.g. methylcellulose, ethylhydroxyethyl cellulose) on effects other than post-prandial blood glucose responses (e.g. safety aspects). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The influence of HPMC on postprandial glucose and insulin responses was investigated in 31 overweight and obese non-diabetic men and women (Maki et al., 2007). Test meals containing 75 g carbohydrate plus 4 or 8 g HPMC or 8 g cellulose (control) were administered to all subjects in a randomised, double-blind fashion, and at least 72 hours apart. Venous blood samples for plasma glucose and serum insulin analyses were collected at 15, 30, 45, 60, 90, 120, 150, and 180 minutes from the start of meal consumption. A sample size of 28 subjects was calculated to detect a difference of 12 % in the incremental area under the glucose concentration curve across interventions with a power of 80 % (α = 0.05 after corrections for comparisons vs control) assuming a pooled SD of 20 %. Peak glucose was significantly lower (P < 0.001) after both HPMC-containing meals (7.4 mmol/L [4 g] and 7.4 mmol/L [8 g]) compared with the control cellulose (8.6 mmol/L). The incremental area under the curve for glucose and insulin, and peak insulin concentration from 0 to 120 minutes were also significantly reduced after both HPMC doses versus control (all P < 0.01), as was the incremental area for glucose from 0 to 180 minutes. No dose-response relationship was observed in this study.
Reppas et al. (1993) investigated the effects of 10 g HPMC added to a standard carbohydrate test meal on post-prandial blood glucose and insulin responses in non diabetic subjects with hypercholesterolaemia (n=10) and in non insulin-dependent diabetic subjects (n=10) following a randomised, double-blind, placebo controlled, cross-over design. Diabetic subjects were asked to discontinue oral hypoglycaemic medications for at least three elimination half-lives before the study. Blood samples were taken at 60, 75, 90, 120, and 150 minutes after consumption of the test meal. No differences between HPMC and placebo were observed for glucose and insulin peaks, or for glucose and insulin areas under the curve in non diabetic subjects. In diabetic subjects, blood glucose concentrations were significantly lower at the 60, 75, 90, 120 and 150-minute sampling times during the HMPC phase compared to placebo, leading to a significant decrease of 14.8 % in the area under the curve. Insulin concentrations were significantly lower during HPMC administration compared to placebo at time 120 minutes, whereas insulin areas under the curve were not affected by the treatment. The Panel considers that the mechanism by which HPMC appears to exert the claimed effect is a delay in glucose absorption in the intestinal tract (see paragraph below), which is unlikely to be affected by the pathophysiology of diabetes mellitus. Therefore, results obtained in non insulin- dependent diabetic subjects not on hypoglycaemic medications can be extrapolated to non-diabetic subjects with, for example, impaired glucose tolerance. The Panel notes that, in the light of the power calculations performed by Maki et al. (2007), the sample size (n=10) of the non-diabetic subjects considered in this study may have been insufficient to observe a significant effect of HPMC on post- prandial blood glucose responses in that population subgroup.
Two intervention studies in dogs using HPMC in glucose solutions at different concentrations to yield low (5,000 cP measured at 37 °C and at a shear rate of 1 s-1), medium (15,000 cP) or high (30,000 cP) viscosities suggest that the effect of HPMC on post-prandial blood glucose concentrations is mediated by a delay in glucose absorption in the intestinal tract, which is dependent on the viscosity and osmolarity (glucose concentration) of the solution (Reppas and Dressman, 1992; Reppas et al., 1999).
In weighing the evidence, the Panel took into account that one human intervention study adequately powered and conducted observed a significant effect of HPMC on the reduction of post-prandial glycaemic responses in obese non-diabetic men and women, that these results are supported by evidence obtained in non insulin-dependent diabetic subjects, and that evidence for a biologically plausible mechanism by which HPMC could exert the claimed effect has been provided.
The Panel concludes that a cause and effect relationship has been established between the consumption of HPMC and a reduction of post-prandial glycaemic responses.

3.3. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 815)

Among the references provided in relation to this claim were those which investigated the effects of food constituents other than HPMC (e.g. methylcellulose, ethylhydroxyethyl cellulose, starch, oats, wholegrain, etc.) on effects other than blood lipids (e.g. post-prandial blood glucose responses, bowel function, safety aspects, etc.). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
In a double-blind, placebo controlled, parallel intervention study (Maki et al., 1999), 160 subjects with low-density lipoprotein (LDL) cholesterol levels between 130 and 200 mg/dL (3.36 and 5.17 mmol/L) and triglycerides <300 mg/dL (3.39 mmol/L) were randomised to consume HPMC at doses of 2.5 g per day (n=36), 5 g per day (n=39), 7.5 g per day (n=41), or placebo (microcrystalline cellulose, n=38) for six weeks. The four intervention groups were comparable for baseline characteristics and an intention-to-treat analysis was used. A significant 12 % reduction in LDL- cholesterol concentrations was observed with the 5 g and 7.5 g HPMC doses compared to placebo. No significant differences were observed between the two doses. It is unclear from the study whether the significant difference observed between the 2.5 g per day dose and the 5 and 7.5 g per day doses was owing to the higher dosage or to the twice-daily dosing schedule followed in the high doses only. The 5 g per day dose showed similar effects on total and LDL-cholesterol concentrations in two weeks when taken either with or between meals (Maki et al., 2000).
Dressman et al. (1993), in a double-blind, randomised crossover trial, studied the effects of large amounts (30 g per day, three 10 g doses consumed with meals) of pre-hydrated, high molecular weight (K8515) HPMC in 10 healthy men for one week and found a significant 32 % (mean decrease -1.45 mmol/L or -56 mg/dL) reduction in total cholesterol concentrations and a significant 38 % decrease in LDL-cholesterol concentrations (-1.10 mmol/L or -42 mg/dL) compared to placebo. In 12 hypercholesterolaemic subjects, the same dose reduced total cholesterol by 21 % and LDL-cholesterol by 31 % as compared with placebo in two weeks. The Panel notes the small sample size and duration of the study.
Swidan et al. (1996) performed a randomised, double-blind, cross-over, placebo controlled study in 12 hypercholesterolaemic subjects to assess the effects of 20 g per day HPMC consumed for one week in cookies and in a jelly compared to placebo (no HPMC). Compared to the control, total
cholesterol and LDL-cholesterol concentrations were significantly reduced by 14 8 % and
19 13 % with the cookie formulation and by 19 7 % and 26 6 % with the jelly formulation, respectively.
Studies in dogs and in vitro suggested that the development of viscosity was slower in the cookie formulation. This difference may have been responsible for the attenuated cholesterol-lowering effect observed in the cookie formulation compared to the jelly formulation.
Reppas et al. (2009) investigated the effects of medium, high, and ultra-high viscosity HPMC (in a sugar-free gelatin dessert consumed at breakfast, lunch and dinner for a total of 15 g per day) compared to placebo (no HPMC) for one week in 12 mildly hypercholesterolaemic subjects
(8 female) in a placebo-controlled, single-blind, cross-over intervention study. Total cholesterol concentrations decreased significantly by 9.3 %, 16.9 %, and 13.8 % and LDL-cholesterol concentrations significantly decreased by 10.6 %, 18.2 % and 17 % in the medium, high and ultra- high viscosity HPMC groups, respectively, compared to placebo. In 40 subjects (20 female), doses of 5 g per day (n=10) and 15 g per day (n=20) of ultra-high viscosity HPMC versus placebo (n=10) were studied over eight weeks following a randomised, double-blinded, placebo-controlled, parallel design. Total and LDL-cholesterol concentrations decreased by 7 % and 8 %, respectively, with the 5 g dose and by 12 % and 15 %, respectively, with the 15 g per day dose.
The effect of HPMC on blood (LDL) cholesterol concentrations is likely to depend on its viscosity, which reduces the reabsorption of bile acids, increases the synthesis of bile acids from cholesterol, and reduces circulating blood cholesterol concentrations.
In weighing the evidence, the Panel took into account that in one study including 160 subjects with adequate follow-up (six weeks), viscous HPMC at daily doses of 5 to 7.5 g per day split in at least two doses had shown a significant reduction in serum total and LDL-cholesterol concentrations. The cholesterol-lowering effect had been documented also in some short-term intervention studies over 1-2 weeks at higher doses of intake, the effect appeared to be dose and viscosity-dependent, and that evidence for a biologically plausible mechanism by which HPMC could exert the claimed effect has been provided.
The Panel concludes that a cause and effect relationship has been established between the consumption of HPMC and maintenance of normal blood cholesterol concentrations.

3.4. Zwiększenie sytości prowadzące do redukcji przyjmowanej energii (ID 2933)

Twenty-four references were cited to substantiate the claim. These references were narrative reviews or intervention studies on the effects of dietary fibre in general or fibre types other than HPMC (e.g. pectins, guar gum, oat fibre) on appetite ratings, energy intake, body weight or outcomes unrelated to energy intake (e.g. bowel function). No studies investigating the effects of HPMC on satiety or energy intake have been provided. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of HPMC and a sustained increase in satiety leading to a reduction in energy intake.

4.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 814)

The Panel considers that the following wording reflects the scientific evidence: “Hydroxypropyl methylcellulose contributes to a reduction of the blood glucose rise after meals”.

4.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 815)

The Panel considers that the following wording reflects the scientific evidence: “Hydroxypropyl methylcellulose contributes to the maintenance of normal blood cholesterol levels”.

5.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 814)

The Panel considers that in order to obtain the claimed effect, at least 4 g of HPMC per meal should be consumed. The target population is adults willing to reduce their post-prandial glycaemic responses.

5.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 815)

The Panel considers that in order to obtain the claimed effect, at least 5 g per day of HPMC should be consumed in two or more servings. The target population is adults.