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Scientific Opinion on the substantiation of health claims related to resistant maltodextrin and reduction of post-prandial glycaemic responses (ID 796), maintenance of normal blood LDL-cholesterol concentrations (ID 2927), maintenance of normal (fasting) blood concentrations of triglycerides (ID 2927) and changes in bowel function (ID 797) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: LDL-cholesterol   Resistant maltodextrin   bowel function   glycaemic responses   health claims   triglycerides  
ID:    2927      797      796  
Produkty: Maltodekstryna oporna na trawienie  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is resistant maltodextrin.
Resistant maltodextrin is produced by pyrolysis and enzymatic hydrolysis of corn starch and is indigestible in the small intestine. Resistant maltodextrin has a molecular weight of 2,000. It is up to 70 % soluble in water at 20° C, and produces clear solutions with very low viscosity.
The Panel considers that the food constituent, resistant maltodextrin, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 796)

The claimed effect is “post-prandial blood glucose”. The Panel assumes that the target population is individuals wishing to reduce their post-prandial glycaemic responses.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the 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 function is a normal physiological response which varies in magnitude and duration, and which 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). Decreasing post-prandial glycaemic responses may, for example, be beneficial to individuals 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.

2.2. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 2927)

The claimed effect is “vascular/heart health; blood lipids”. 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 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.

2.3. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 2927)

The claimed effect is “vascular/heart health; blood lipids”. 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 (fasting) blood concentrations of triglycerides.
Triglycerides in plasma are either derived from dietary fats or synthesised in the body from other energy sources like carbohydrates. In fasting conditions, serum triglycerides are mainly transported in very-low-density lipoproteins (VLDL) synthesised in the liver. Hormones regulate the release of triglycerides from adipose tissue in order to meet energy needs between meals.
The Panel considers that maintenance of normal (fasting) blood concentrations of triglycerides may be a beneficial physiological effect.

2.4. Zmiany w funkcjach jelita (ID 797)

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 changes in bowel function by promoting intestinal regularity and reducing intestinal transit time.
The Panel considers that changes in bowel function, such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools, may be a beneficial physiological effect provided these changes do not result in diarrhoea.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka

The majority of the references provided in relation to the claims evaluated in this opinion were full text articles in Japanese for which only the abstract was available in English. The limited information available to the Panel in an EU language did not allow a full evaluation of these references.

3.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 796)

Of the three references provided with a full text in an EU language in relation to this claim, one addressed the characterisation of indigestible maltodextrin and one reported on post-prandial blood
concentrations of triglycerides. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
A human intervention study investigated the effects of supplemental resistant maltodextrin on post-prandial glucose response to a rapidly digested starch in 30 non-diabetic subjects using a randomised, cross-over design (Wolf et al., 2001). Subjects consumed a product containing 67.5 g of corn syrup solids or the same amount plus 16 g of resistant maltodextrin. The post-prandial incremental changes from baseline in blood glucose concentrations (measured at 30-min intervals up to two hours) did not significantly differ between interventions at any time point. Mean peak incremental change from baseline, and net incremental area under the curve also did not significantly differ between interventions.
The Panel notes that the only reference from which conclusions can be drawn for the scientific substantiation of the claimed effect did not show an effect of resistant maltodextrin on post-prandial glycaemic responses. In addition, post-prandial insulinaemic responses were not reported.
The Panel concludes that a cause and effect relationship has not been established between the consumption of resistant maltodextrin and reduction of post-prandial glycaemic responses.

3.2. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 2927)

No references in relation to the effects of resistant maltodextrin on blood LDL-cholesterol concentrations with the full text in an EU language were provided in the consolidated list and no translation into an EU language was available to the Panel.
The Panel concludes that a cause and effect relationship has not been established between the consumption of resistant maltodextrin and maintenance of normal blood LDL-cholesterol concentrations.

3.3. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 2927)

The only reference provided in relation to this claim for which the full text was available in an EU language investigated the acute effects of 5-10 g resistant maltodextrin added to a meal containing 50 g fat on post-prandial concentrations of triglycerides in 13 healthy adults (Kishimoto et al., 2007). The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of resistant maltodextrin and maintenance of normal (fasting) blood concentrations of triglycerides.

3.4. Zmiany w funkcjach jelita (ID 797)

No references in relation to the effects of resistant maltodextrin on bowel function with the full text in an EU language were provided in the consolidated list and no translation into an EU language was available to the Panel.
The Panel concludes that a cause and effect relationship has not been established between the consumption of resistant maltodextrin and changes in bowel function.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, resistant maltodextrin, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.
Reduction of post-prandial glycaemic responses (ID 796)
The claimed effect is “post-prandial blood glucose”. The target population is assumed to be individuals wishing to reduce their post-prandial glycaemic responses. Reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) may be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of resistant maltodextrin and reduction of post-prandial glycaemic responses.
Maintenance of normal blood LDL-cholesterol concentrations (ID 2927)
The claimed effect is “vascular/heart health; blood lipids”. The target population is assumed to be the general population. In the context of the proposed wordings, it is assumed that the claimed effect refers to the maintenance of normal blood LDL-cholesterol concentrations. Maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of resistant maltodextrin and maintenance of normal blood LDL-cholesterol concentrations.
Maintenance of normal (fasting) blood concentrations of triglycerides (ID 2927)
The claimed effect is “vascular/heart health; blood lipids”. The target population is assumed to be the general population. In the context of the proposed wordings, it is assumed that the claimed effect refers to the maintenance of normal (fasting) blood concentrations of triglycerides. Maintenance of normal (fasting) blood concentrations of triglycerides may be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of resistant maltodextrin and maintenance of normal (fasting) blood concentrations of triglycerides.
Changes in bowel function (ID 797)
The claimed effect is “bowel function”. The target population is assumed to be the general population. In the context of the proposed wordings, it is assumed that the claimed effect refers to changes in bowel function. Changes in bowel function, such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools, may be a beneficial physiological effect provided they do not result in diarrhoea.
A cause and effect relationship has not been established between the consumption of resistant maltodextrin and changes in bowel function.