ID 349 - Wapń

PL: Wapń
EN: Calcium
Pdf: calcium

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is calcium, which is a well recognised nutrient and is measurable in foods by established methods. Calcium occurs naturally in foods in many forms which are generally well utilised by the body. Different forms of calcium are authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/20066 and Annex II of Directive 2002/46/EC7). This evaluation applies to calcium naturally present in foods and those forms authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, calcium, which is the subject of the health claims, is sufficiently characterised.

2.3. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 349, 1893)

The claimed effect is “cholesterol: calcium reduces LDL-cholesterol and increases HDL-cholesterol. calcium participates to the control of cholesterol”. 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.

2.4. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 349, 1893)

The claimed effect is “cholesterol: calcium reduces LDL-cholesterol and increases-HDL cholesterol. Calcium participates to the control of cholesterol”. 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 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 blood HDL-cholesterol concentrations (without increasing LDL-cholesterol concentrations) may be a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

More than 99 % of the total calcium in the body is located in bones and teeth and contributes to their mass, structure and strength. Besides this structural role, calcium acts as an intracellular messenger and as a cofactor for extracellular enzymes and proteins. Overt, symptomatic calcium deficiencies are almost nonexistent given the large skeletal reserves, although inadequate calcium intakes have been associated with a higher risk of bone fractures (IoM, 1997, Weaver and Heaney, 2006).

3.2. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 349, 1893)

Two references were cited for the substantiation of this claim. One was a review on the composition and mineralisation of mollusc shell proteins. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect. The second was a narrative review on the effects of calcium intake on blood lipids (Reid, 2004), which refers to a series of small- scale and short-term randomised, placebo controlled trials on the effects of calcium supplementation in various forms (carbonate, citrate, phosphate) on LDL-cholesterol concentrations. The Panel has also identified a number of studies which were published after 2004 and were not included in the review.
Three small-scale and short-term randomised, placebo control trials (RCTs) have observed a statistically significant reduction of LDL-cholesterol (4-11 %) concentrations following the administration of 1 to 2 g per day of calcium compared to placebo (Groot et al., 1980; Bell et al., 1992; Denke et al., 1993). However, four other small-scale and short-term RCTs have shown no effect (Ditscheid et al., 2005; Bostick et al., 2000; Karandish et al., 2009; Karanja et al., 1987). A large RCT originally designed to assess the effects of calcium supplementation on bone health also addressed the effect of calcium supplementation on LDL-cholesterol concentrations. A total of 223 postmenopausal women were randomly assigned to consume either calcium citrate (1 g/d, n = 111) or placebo (n = 112) for one year (Reid et al., 2002). Changes in LDL-cholesterol concentrations were not significantly different between the intervention and placebo groups.
In a recently published RCT on the effects of calcium supplementation on blood lipids (primary outcome) a total of 323 healthy men were randomly assigned to consume either calcium (600 mg/d, n=108 or 1200 mg/d, n=108) or placebo (n=107) for two years (Reid et al., 2010). No significant differences between the calcium and placebo groups were observed with respect to changes in total
cholesterol, LDL- and HDL-cholesterol, and triglyceride concentrations or in the HDL to LDL- cholesterol ratio during the study.
No evidence was provided for a biologically plausible mechanism by which calcium could exert the claimed effect.
In weighing the evidence, the Panel took into account that six out of nine RCTs, including two large RCTs, showed no effect of calcium intake on LDL-cholesterol concentrations, and that no evidence was provided for a biologically plausible mechanism by which calcium could exert the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of calcium and maintenance of normal blood LDL-cholesterol concentrations.

3.3. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 349, 1893)

Two references were cited for the substantiation of this claim. One was a review on the composition and mineralisation of mollusc shell proteins. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect. The second was a narrative review on the effects of calcium intake on blood lipids (Reid, 2004), which refers to a series of small- scale and short-term randomised, placebo controlled trials on the effects of calcium supplementation in various forms (carbonate, citrate, phosphate) on HDL-cholesterol concentrations. The Panel has also identified a number of studies which were published after 2004 and were not included in the review, including two large RCTs. Of the smaller studies, one observed a statistically significant increase in HDL-cholesterol concentrations following the administration of 1 to 2 g per day of calcium compared to placebo (Bell et al., 1992), whereas six others showed no effect in adults with normal or elevated blood cholesterol concentrations (Groot et al., 1980; Denke et al., 1993; Ditscheid et al., 2005; Bostick et al., 2000; Karandish et al., 2009; Karanja et al., 1987).
A large RCT originally designed to assess the effects of calcium supplementation on bone health also assessed the effect of calcium supplementation on HDL-cholesterol concentrations. A total of 223 postmenopausal women were randomly assigned to consume either calcium citrate (1 g/d, n=111) or placebo (n=112) for one year (Reid et al., 2002). HDL-cholesterol concentrations and the HDL to LDL-cholesterol ratio significantly increased in the intervention group (by 0.09 mmol/L; 95 % CI=0.02-0.17, and by 0.05; 95 % CI=0.02-0.08; respectively) compared to placebo during the study.
In a recently published RCT on the effects of calcium supplementation on blood lipids (primary outcome) a total of 323 healthy men were randomly assigned to consume either calcium (600 mg/d, n=108 or 1200 mg/d, n=108) or placebo (n=107) for two years (Reid et al., 2010). No significant differences between the calcium and placebo groups were observed with respect to changes in total cholesterol, LDL- and HDL-cholesterol, and triglyceride concentrations or in the HDL to LDL ratio during the study.
No evidence was provided for a biologically plausible mechanism by which calcium could exert the claimed effect.
In weighing the evidence, the Panel took into account that six of the seven small RCTs showed no effect of calcium intake on HDL-cholesterol concentrations, that one large RCT not designed to address the effects of calcium intake on blood lipids showed a significant increase in HDL-cholesterol concentrations, that results from the largest RCT available which was specifically designed to address the effects of calcium intake on blood lipids showed no effect of calcium supplementation on HDL- cholesterol concentrations, and that no evidence was provided for a biologically plausible mechanism by which calcium could exert the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of calcium and the maintenance of normal blood HDL-cholesterol concentrations.

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