ID 815 -
Hypromeloza
PL: Hypromeloza
EN: Hydroxypropyl methylcellulose (HPMC)Dietary Fibre
Pdf: hydroxypropyl methylcellulose
Oświadczenie (4)
- Hydroksypropylometyloceluloza przyczynia się do utrzymania prawidłowego stężenia cholesterolu we krwi
Oświadczenie (2)
- utrzymanie prawidłowego poziomu cholesterolu
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.
2.3. 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.
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.
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”.
5.2. 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.
Warunki i możliwe ograniczenia stosowania oświadczenia
Products carrying the claim should contain a single serving of 1.25 grams per serving.
Recommended daily use is 2.5 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."