ID 814 - Hypromeloza

PL: Hypromeloza
EN: Hydroxypropyl methylcellulose (HPMC)Dietary Fibre
Pdf: hydroxypropyl methylcellulose

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is hydroxypropyl methylcellulose (HPMC).
HPMC is a food additive (Codex Alimentarius E 464) used as an emulsifier, or as a thickening and suspending agent, which forms colloids when dissolved in water. The viscosity of HPMC is directly related to the concentration of the methoxy group (the higher the concentration the more viscous). HMPC is non-available for digestion in the human intestine. Analytical methods have been developed for the analysis of HMPC.
The Panel considers that the food constituent, hydroxypropyl methylcellulose (HPMC), which is the subject of the health claims is sufficiently characterised.

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.

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.

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”.

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.

Warunki i możliwe ograniczenia stosowania oświadczenia

Products carrying the claim should contain a single serving of 1 gram per serving. Recommended daily use is 2 grams per day. There is no upper safe limit. HPMC Acceptable Daily Intake (ADI) is “not specified” as adopted in 1994 by the Scientific Committee on Food for five closely related cellulose derivatives, including hydroxypropyl methyl cellulose. A 2007 ‘Safety assessment of hydroxypropyl methylcellulose as a food ingredient’ by G.A. Burdock published in Food and Chemical Toxicology (Elsevier) states that "These data indicate that at the current level of intake, HPMC does not pose a health risk to humans."