ID 1954 -
Polikozanole z trzciny cukrowej
PL: Polikozanole z trzciny cukrowej
EN: Sugar cane extract
Pdf: policosanols from sugar cane wax
1. Charakterystyka żywności / składnika
The food constituents that are the subject of the health claims are “policosanols”, “sugar cane extract” and “policosanol/blend of aliphatic alcohols - consisting primarily of 1-Octacosanol, 1-Triacontanol, 1-Tetracosanol and 1-Hexacosanol - from sugar cane (Saccharum officinarum)”.
Commercial policosanol preparations are a mixture of long-chain primary alcohols derived from sugar cane wax (Saccharum officinarum L.) with chain lengths varying from 24 to 34 carbon atoms. Policosanols can also be derived from a variety of other plant sources, including wheat germ oil, and their composition depends on the source.
From the references provided, the Panel assumes that the food constituent which is the subject of the health claims is policosanols from sugar cane wax.
Sugar cane-derived policosanols contain 66-67 % octacosanol (28-C), 12-14 % triacosanol (30-C), 7-8 % hexacosanol (26-C) and 11-15 % of other carbon alcohols, including tetracosanol (24-C), heptacosanol (27-C), nonacosanol (29-C), dotriacontanol (32-C) and tetratriacontanol (34-C) (Natural Medicines Comprehensive Database, 2006).
The Panel considers that the food constituent, policosanols from sugar cane wax, which is the subject of the health claims, is sufficiently characterised.
2.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 1747, 1748, 1864, 1951, 1954, 4693)
The claimed effects are “cholesterol”, “support for healthy blood lipid levels”, and “cardiovascular system”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal 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 (>4.1 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.
2.2. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 1747, 1748, 1864, 1951, 1954, 4693)
The claimed effects are “cholesterol”, “support for healthy blood lipid levels”, and “cardiovascular system”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal HDL-cholesterol concentrations.
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). Conversely, low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries.
The Panel considers that maintenance of normal HDL-cholesterol concentrations (without increasing LDL-cholesterol concentrations) is a beneficial physiological effect.
3.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 1747, 1748, 1864, 1951, 1954, 4693)
Some of the references provided for the scientific substantiation of the claim reported on health outcomes (e.g. platelet aggregation, intermittent claudication, in vitro LDL oxidation) other than changes in the blood lipid profile. Also, narrative reviews on the effects of policosanols on blood lipids were provided. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Fourteen references reported on 13 human intervention studies which investigated the effects of policosanol consumption on blood lipids. Two references reported on the same study (Kassis and Jones, 2006, 2008).
All of these studies except four (Berthold et al., 2006; Francini-Pesenti et al., 2008a; 2008b; Kassis and Jones, 2006, 2008) were conducted in Cuba in Cuban subjects by a single research team using policosanols from Cuban sugar cane wax produced by a single company. In these placebo-controlled, double-blind, randomised controlled trials, the efficacy of policosanols on blood lipids was studied in groups of hypercholesterolaemic subjects (non-insulin dependent diabetics, post-menopausal women, elderly, subjects at high risk of coronary heart disease) (Batista et al., 1996; Canetti et al., 1997; Castaño et al., 1995; Castaño et al., 1999; 2001; 2005; Crespo et al., 1999; Pons et al., 1994), and in one group of healthy subjects (Hernández et al., 1992). Sample sizes varied between 22 and 244 subjects, doses between 5 and 20 mg policosanols per day, and treatment periods between four weeks and 24 months. In one study using 10 mg/day policosanols, subjects (n=85) were followed up for five years (open three-year follow up after participation in a two-year controlled intervention trial). Efficacy was found to be maintained during this long-term follow up (Canetti et al., 1997). In these studies the (statistically significant) reductions reported for total and LDL-cholesterol concentrations
varied between 17-21 % and 21-29 %, respectively. Similar results were reported in a meta-analysis of randomised controlled trials in which these studies were included (Chen et al., 2005).
A multicentre (lipid outpatient clinics and general practitioners in Germany), randomised, double-blind, placebo-controlled, parallel group intervention trial was designed to corroborate the reported lipid-lowering effects of policosanols from Cuban sugar cane wax. The policosanols used in this study were provided by the same company as in the studies described above (Berthold et al., 2006). A total of 143 subjects with hypercholesterolaemia or combined hyperlipidaemia (LDL-cholesterol concentrations >3.88 mmol/L) and either no or one risk factor for cardiovascular disease (CVD) other than known coronary heart disease (CHD), or baseline LDL-cholesterol concentrations between 3.88 and 4.89 mmol/L and two or more risk factors for CVD, were randomised to one of the five following groups after an open-label six-week placebo and diet run-in phase: 10 mg/day (n=28), 20 mg/day (n=27), 40 mg/day (n=27), or 80 mg/day (n=32) of policosanols, or placebo (n=29). The intervention phase lasted 12 weeks. Sample size was calculated based on the percentage change of LDL-cholesterol concentrations from baseline, a level of significance of p<0.025 (1-sided), and a power of 80 %. It was expected that the active treatment would result in an LDL-cholesterol decrease of at least 10 % (with an SD of 11 %) compared with placebo. To achieve the calculated power, 20 patients per intervention group were needed. Results were analysed on an intention-to-treat basis. A total of 129 subjects completed the trial. In none of the five treatment groups did LDL-cholesterol concentrations decrease more than 10 % from baseline. No statistically significant differences between any of the policosanol groups and placebo were observed. There was no significant dose-response relationship between policosanol intake and changes in LDL-cholesterol concentrations. No statistically significant differences between any of the policosanol groups and placebo were observed for any of the secondary outcome measures, i.e. total cholesterol, HDL-cholesterol, VLDL-(very low density lipoprotein) cholesterol, triglycerides, lipoprotein(a), and ratio of total or LDL- to HDL-cholesterol. The Panel notes that this study does not show an effect of policosanols at doses from 10 to 80 mg/day on LDL-cholesterol concentrations.
In a double-blind, randomised, placebo-controlled study, 68 subjects with LDL-cholesterol concentrations between 160 and 250 mg/dL followed a normocaloric diet according to the National Cholesterol Education Program Adult Treatment Panel III for three months, and thereafter were randomised to consume either two tablets of policosanols (each tablet containing 10 mg policosanols from Cuban sugar cane wax) or placebo (calcium phosphate, calcium carbonate and magnesium stearate) after dinner for eight weeks, while following their usual lifestyle and a normocaloric diet (Francini-Pesenti et al., 2008a). It was estimated that to achieve 80 % power to detect a reduction in serum LDL-cholesterol concentrations of 20 % at a 2-sided significance level of 5 %, 30 subjects per group would be required. Thirty-one subjects (16 males, mean age 52±6 years) in the policosanol group and 32 subjects (14 males, mean age 54±7 years) in the placebo group completed the study. Reasons for withdrawal were reported and analyses were provided on completers only. No statistically significant changes in total or LDL-cholesterol concentrations (-2.8 mg/dL vs. -2.0 mg/dL, p=0.34; -0.9 mg/dL vs. -0.3 mg/dL, p=0.89, respectively) nor in HDL-cholesterol concentrations (+1.9 mg/dL vs. +2.9 mg/dL, p=0.66) were observed between the policosanol and the placebo groups. The Panel notes that this study does not show an effect of policosanol consumption at doses of 20 mg/day on blood LDL-cholesterol concentrations.
The same group conducted another double-blind, randomised, placebo-controlled study in which 70 subjects with LDL-cholesterol concentrations between 4.0 and 5.2 mmol/L who had reduced their LDL-cholesterol concentrations more than 0.3 mmol/L by following a normocaloric diet according to the National Cholesterol Education Program Adult Treatment Panel III were randomised to consume one tablet daily containing either 10 mg of policosanols from Cuban sugar cane wax or placebo (calcium phosphate, calcium carbonate and magnesium stearate) after dinner for eight weeks, while following their usual lifestyle and a normocaloric diet (Francini-Pesenti et al., 2008b). Power calculations were performed as described in the study by Francini-Pesenti et al. (2008a). Thirty-three
subjects (11 males, mean age 48±5 years) in the policosanol group and 31 subjects (14 males, mean age 53±6 years) in the placebo group completed the study. Reasons for withdrawal were reported and analyses were provided on completers only. No statistically significant changes in total or LDL-cholesterol concentrations (-0.01 mmol/L vs. -0.05 mmol/L, p=0.69; -0.01 mmol/L vs. +0.11 mmol/L, p=0.94 respectively), nor in HDL-cholesterol concentrations (+0.07 mmol/L vs. +0.03 mmol/L, p=0.66) were observed between the policosanol and the placebo groups. The Panel notes that this study does not show an effect of policosanol consumption at doses of 10 mg/day on blood cholesterol concentrations.
In a double-blind, placebo-controlled, cross-over study by Kassis and Jones (2006, 2008) 22 subjects with LDL-cholesterol concentrations between 3.0 and 5.0 mmol/L were recruited to receive either 10 g margarine containing 10 mg policosanols derived from sugar cane wax or a placebo margarine for 28 days each, with a 28-day wash-out period in between. A sample size of 21 was calculated to provide an 80 % probability of detecting a difference of 20 % between groups in the parameters measured, using a coefficient of variation of 15-20 %. Statistical significance was set at p<0.05. Twenty-one subjects (12 males, mean age 57.8±2.1 years) completed the study. On day 25 of each study period, subjects were administered 10 g of margarine providing 75 mg of stable isotope-labelled cholesterol in order to assess cholesterol absorption. On day 28 of each study period, a dose of deuterium oxide was given to subjects in order to determine the amounts of cholesterol biosynthesis by measuring deuterium incorporation into red blood cell membrane free cholesterol over 24 hours. No statistically significant changes were observed in total or LDL-cholesterol concentrations (+1.8±3.0 % vs. -4.0±3.0 %, p=0.18; +4.5±4.0 % vs. -1.6±4.0 %, p=0.28, respectively), nor in HDL- cholesterol concentrations (-2.7±3.0 % vs. -7.4±3.0 %, p=0.19) between the intervention and placebo periods. No statistically significant differences in the area under the curve (AUC) for cholesterol absorption or in the fractional rate of cholesterol synthesis were found between the intervention and the control periods. The Panel notes that this study does not show an effect of policosanol consumption at doses of 10 mg/day on blood cholesterol concentrations, on cholesterol absorption, or on the rate of endogenous cholesterol synthesis.
The Panel notes that although the majority of the studies conducted in Cuban subjects reported significant reductions in total and LDL-cholesterol concentrations between 17-21 % and 21-29 % respectively following consumption of policosanols from sugar cane wax at doses between 5 and 20 mg/day, no effect on total or LDL-cholesterol concentrations was found in human intervention studies conducted in other parts of the world at doses ranging from 10 to 80 mg/day.
The Panel also notes that no effect of policosanols from sugar cane wax on cholesterol absorption or on the rate of endogenous cholesterol synthesis has been observed in vivo in humans (Kassis and Jones, 2006, 2008), and that no evidence for a mechanism by which policosanols could exert the claimed effect has been provided.
In weighing the evidence, the Panel took into account that the results from human intervention studies which assessed the effects of policosanols from sugar cane wax on total and LDL-cholesterol concentrations are inconsistent, and that no evidence for a mechanism by which policosanols from sugar cane wax could exert the claimed effect has been provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of policosanols from sugar cane wax and maintenance of normal blood LDL-cholesterol concentrations.
3.2. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 1747, 1748, 1864, 1951, 1954, 4693)
The same human intervention studies described in section 3.1 also reported on the effects of consumption of policosanol from sugar cane wax on HDL-cholesterol concentrations. Whereas the nine human intervention studies conducted in Cuban subjects generally reported a statistically significant increase in HDL-cholesterol concentrations which varied between 8 and 15 % (Batista et al., 1996; Canetti et al., 1997; Castaño et al., 1995; Castaño et al., 1999; 2001; 2005; Crespo et al., 1999; Hernández et al., 1992; Pons et al., 1994), no significant effect was observed in the four studies conducted in other parts of the world (Berthold et al., 2006; Francini-Pesenti et al., 2008a; 2008b; Kassis and Jones, 2006, 2008), and no evidence for a mechanism by which policosanols from sugar cane wax could exert the claimed effect has been provided.
In weighing the evidence, the Panel took into account that the results from human intervention studies which assessed the effects of policosanols from sugar cane wax on HDL-cholesterol concentrations are inconsistent, and that no evidence for a mechanism by which policosanols from sugar cane wax could exert the claimed effect has been provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of policosanols from sugar cane wax and maintenance of normal blood HDL-cholesterol concentrations.
Warunki i możliwe ograniczenia stosowania oświadczenia
At least 5 mg per day
