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Scientific Opinion on the substantiation of health claims related to resistant starch and reduction of post-prandial glycaemic responses (ID 681), “digestive health benefits” (ID 682) and “favours a normal colon metabolism” (ID 783) 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: Resistant starch   colon metabolism   digestive health   health claims   high amylose maize   post-prandial glycaemic responses  
ID:    682      681      783  
Produkty: Skrobia oporna na trawienie  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is resistant starch-type 2 from high amylose maize.
Resistant starch (RS) is defined as starch that escapes digestion and absorption in the small intestine of healthy subjects, and can be classified into four types: RS1 is physically inaccessible to digestion, RS2 describes native starch granules that are protected from digestion by the conformation or structure of the granule, RS3 refers to non-granular starch-derived materials which are generally formed during retrogradation of starch granules in food processing, and RS4 are starches not found in nature which have been chemically modified to decrease their digestibility (Nugent, 2005).
RS from high amylose maize (amylose content between 50 % and 90 %) is categorised as RS2, and is produced from a traditionally bred hybrid of high amylose maize that contains a mixture of digestible and resistant starch. The starch granules in high amylose maize are very stable, and tend not to gelatinise when subjected to the processing conditions used in the manufacture of many common foods.
Methods are available to measure these starch fractions in the laboratory (McCleary and Monaghan, 2002).
The Panel considers that the food constituent, resistant starch from high amylose maize (RS2), which is the subject of the health claims, is sufficiently characterised.
The food constituent that is the subject of the health claim is resistant starch-type 2 from high amylose maize.
Resistant starch (RS) is defined as starch that escapes digestion and absorption in the small intestine of healthy subjects, and can be classified into four types: RS1 is physically inaccessible to digestion, RS2 describes native starch granules that are protected from digestion by the conformation or structure of the granule, RS3 refers to non-granular starch-derived materials which are generally formed during retrogradation of starch granules in food processing, and RS4 are starches not found in nature which have been chemically modified to decrease their digestibility (Nugent, 2005).
RS from high amylose maize (amylose content between 50 % and 90 %) is categorised as RS2, and is produced from a traditionally bred hybrid of high amylose maize that contains a mixture of digestible and resistant starch. The starch granules in high amylose maize are very stable, and tend not to gelatinise when subjected to the processing conditions used in the manufacture of many common foods.
Methods are available to measure these starch fractions in the laboratory (McCleary and Monaghan, 2002).
The Panel considers that the food constituent, resistant starch from high amylose maize (RS2), which is the subject of the health claims, is sufficiently characterised.
The food constituent that is the subject of the health claim is resistant starch-type 2 from high amylose maize.
Resistant starch (RS) is defined as starch that escapes digestion and absorption in the small intestine of healthy subjects, and can be classified into four types: RS1 is physically inaccessible to digestion, RS2 describes native starch granules that are protected from digestion by the conformation or structure of the granule, RS3 refers to non-granular starch-derived materials which are generally formed during retrogradation of starch granules in food processing, and RS4 are starches not found in nature which have been chemically modified to decrease their digestibility (Nugent, 2005).
RS from high amylose maize (amylose content between 50 % and 90 %) is categorised as RS2, and is produced from a traditionally bred hybrid of high amylose maize that contains a mixture of digestible and resistant starch. The starch granules in high amylose maize are very stable, and tend not to gelatinise when subjected to the processing conditions used in the manufacture of many common foods.
Methods are available to measure these starch fractions in the laboratory (McCleary and Monaghan, 2002).
The Panel considers that the food constituent, resistant starch from high amylose maize (RS2), which is the subject of the health claims, is sufficiently characterised.
The food constituent that is the subject of the health claim is resistant starch-type 2 from high amylose maize.
Resistant starch (RS) is defined as starch that escapes digestion and absorption in the small intestine of healthy subjects, and can be classified into four types: RS1 is physically inaccessible to digestion, RS2 describes native starch granules that are protected from digestion by the conformation or structure of the granule, RS3 refers to non-granular starch-derived materials which are generally formed during retrogradation of starch granules in food processing, and RS4 are starches not found in nature which have been chemically modified to decrease their digestibility (Nugent, 2005).
RS from high amylose maize (amylose content between 50 % and 90 %) is categorised as RS2, and is produced from a traditionally bred hybrid of high amylose maize that contains a mixture of digestible and resistant starch. The starch granules in high amylose maize are very stable, and tend not to gelatinise when subjected to the processing conditions used in the manufacture of many common foods.
Methods are available to measure these starch fractions in the laboratory (McCleary and Monaghan, 2002).
The Panel considers that the food constituent, resistant starch from high amylose maize (RS2), which is the subject of the health claims, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 681)

The claimed effect is “healthy blood glucose/sugar levels”. 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 that 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 be beneficial to subjects with, for example, impaired glucose tolerance, as long as post-prandial insulinaemic responses are not disproportionally increased. Impaired glucose tolerance is common in the general adult population.
The Panel considers that the 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. Korzystny wpływ na zdrowie układu pokarmowego (ID 682)

The claimed effect is “digestive health benefits”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined, and no further details were provided in the proposed wordings.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

2.3. Sprzyja prawidłowemu metabolizmowi jelita grubego (ID 783)

The claimed effect is “favours a normal colon metabolism”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined, and no more details were provided in the proposed wordings.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 


3.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 681)

The references provided in relation to the claim included one reference on the PASSCLAIM project (Aggett et al., 2005) and one narrative review on the health properties of all types of resistant starch (Nugent, 2005). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
One reference reported on the effects of a typical American diet containing 20 % of calories from either high-amylose corn starch or from fructose on glucose tolerance after a five-week intervention (Reiser et al., 1989). The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claim.
A dossier for the substantiation of an Article 13 health claim was provided (de la Hunty and Ashwell, 2008). The dossier included a systematic review (and meta-analysis where appropriate) on the effects of starch from high amylose maize in substitution of normal flour in standard food items such as
bread, muffins, cookies and corn chips on post-prandial blood glucose and insulin concentrations. A total of 16 relevant studies were identified, 15 of which had been provided as individual references for the substantiation of the claim. Ten studies were conducted in healthy men and women (Behall et al., 1988; Behall and Hallfrisch, 2002; Behall and Scholfield, 2005; Brighenti et al., 2006; Granfeldt et al., 1995; Higgins et al., 2004; Hoebler et al., 1999; Jenkins et al., 1998; Muir et al., 1994; Quilez et al., 2007), one in healthy men (Behall et al., 1989), one in healthy women (Weickert et al., 2005), one in overweight men (Behall et al., 2006a), one in overweight women (Behall et al., 2006b), one in men with hypertriglyceridaemia (Noakes et al., 1996), and one in men with hyperinsulinaemia (Behall and Howe, 1995). The Panel notes that in two studies the macronutrient composition of the test and control foods (particularly the fat content) was not comparable, which could have influenced the results obtained (Granfeldt et al., 1995; Quilez et al., 2007). The Panel considers that no conclusions can be drawn from these references, and therefore from the meta-analysis provided, for the scientific substantiation of the claim.
Most of the remaining studies used either a cross-over or Latin square design and assessed post-prandial glycaemic and insulinaemic responses after food (or meal) tests in which common baked foods (e.g. crackers, bread and muffins) were made from either regular maize or wheat flour, from high amylose (50-90 %) maize flour, or from a combination of them. Blood samples were taken for glucose and insulin analysis at 15 min and 30 min, and thereafter every 30 minutes up to at least 2 hours (except for Noakes et al., (1996) where blood sampling was up to 105 min), and generally up to 3 to 4 hours. All the studies except two (Hoebler et al., 1999; Weickert et al., 2005) included at least 10 subjects. Results are generally expressed as the difference between test and control food products (or meals) in post-prandial blood glucose and insulin concentrations at different time points, and as differences in the areas under the curve (AUC) for glucose and insulin. The Panel notes that even if in three of the studies the amount of RS2 in the test and control products has not been reported (Behall et al., 1988; 1989; Behall and Howe, 1995), this could be estimated from the amylose content of the high amylose maize starch used (Behall and Hallfrisch, 2002), and could be used as supportive evidence for the scientific substantiation of the claim.
Most of the studies provided report a statistically significant decrease in post-prandial glycaemic and insulinaemic responses when starch from high amylose maize replaces almost fully digestible starch in test products (Behall et al., 1988; 1989; Behall and Howe, 1995; Behall and Hallfrisch, 2002; Behall and Scholfield, 2005; Behall et al., 2006a; 2006b; Brighenti et al., 2006; Hoebler et al., 1999; Noakes et al., 1996), but not when the amount of available carbohydrates is maintained constant in the test and control products (Jenkins et al., 1998; Weickert et al., 2005) or when the replacement of starch by resistant starch is lower than about 14 % of total starch (Behall and Hallfrisch, 2002; Muir et al., 1994). This suggests that the replacement of digestible starch in carbohydrate-containing foods by RS2 from high amylose maize would decrease post-prandial glycaemic and insulinaemic responses due to the replacement of digestible carbohydrates by indigestible carbohydrates, so that the amount of available glucose contributing to glycaemia is reduced, whereas the addition of RS2 to carbohydrate-containing foods does not appear to modify the post-prandial glucose responses to digestible starch (i.e. when the amount of glycaemic carbohydrates is kept constant). The Panel notes that the effect of replacing digestible starch in foods with resistant starch on post-prandial glycaemic responses could be expected from all types of resistant starch, and that this effect is not specific to RS2 from high amylose maize.
Behall and Hallfrish (2002) addressed the lowest effective dose at which RS2 should be consumed as a replacement of digestible starch in order to obtain the claimed effect. In this study, 25 overweight subjects consumed breads made from maize starches with different amylose content (ranging from 30 % to 70 %). The dose of available carbohydrates linearly decreased, and the amount of resistant starch (expressed as % of total starch) significantly increased, in breads made from starches with increasing percentages of amylose. The level of RS2 needed for a significant reduction in post-prandial glucose or insulin responses was assessed. The amylose content of the starch used in
acute meals needed to be at least 60 % amylose to significantly reduce the post-prandial glucose responses. This level of amylose was equivalent to a minimum intake of 11.5 g RS2 in a serving of 80 g total carbohydrates and 68 g of available carbohydrates. The Panel notes that the amount of RS2 used to achieve the claimed effect was 14 % of total starch. In weighing the evidence, the Panel took into account that most of the studies provided reported a significant decrease in post-prandial glycaemic responses, without significantly increasing insulinaemic responses, following consumption of RS2 as a partial replacement of digestible starch in baked foods, and that the effect is generally not observed when the amount of available carbohydrates is maintained constant in the test and control products. This suggests that the replacement of digestible starch in carbohydrate-containing foods with RS2 from high amylose maize would decrease post-prandial glycaemic and insulinaemic responses due to the replacement of digestible carbohydrates by indigestible carbohydrates, so that the amount of available glucose contributing to glycaemia is reduced, whereas the addition of RS2 to carbohydrate-containing foods does not appear to modify the post-prandial glucose responses to digestible starch (i.e. when the amount of glycaemic carbohydrates is kept constant). The Panel notes that the effect of replacing digestible starch in foods with resistant starch on post-prandial glycaemic responses could be expected from all types of resistant starch, and that this effect is not specific to RS2 from high amylose maize.
The Panel concludes that a cause and effect relationship has been established between the consumption of resistant starch from all sources, when replacing digestible starch in baked foods, and a reduction of post-prandial glycaemic responses.

4. Uwagi do zaproponowanego brzmienia oświadczenia


4.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 681)

The Panel considers that the following wording reflects the scientific evidence: “Replacing digestible starch with resistant starch induces a lower blood glucose rise after a meal”.

5. Warunki i możliwe ograniczenia stosowania oświadczenia


5.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 681)

The Panel considers that in order to bear the claim, high carbohydrate baked foods should contain at least 14 % of total starch as resistant starch, in replacement to digestible starch. The target population is individuals wishing to reduce their post-prandial glycaemic responses.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, resistant starch from high amylose maize (RS2), which is the subject of the health claims, is sufficiently characterised.
Reduction of post-prandial glycaemic responses (ID 681)
The claimed effect is “healthy blood glucose/sugar levels”. The target population is assumed to be subjects wishing to reduce their post-prandial glycaemic responses. The 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 been established between the consumption of resistant starch from all sources, when replacing digestible starch in baked foods, and a reduction of post-prandial glycaemic responses.
The following wording reflects the scientific evidence: “Replacing digestible starch with resistant starch induces a lower blood glucose rise after a meal”.
The Panel considers that in order to bear the claim, high carbohydrate baked foods should contain at least 14 % of total starch as resistant starch, in replacement to digestible starch. The target population is individuals wishing to reduce their post-prandial glycaemic responses.
“Digestive health benefits” (ID 682)
The claimed effect is “digestive health benefits”. The target population is assumed to be the general population.
The claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
“Favours a normal colon metabolism” (ID 783)
The claimed effect is “favours a normal colon metabolism”. The target population is assumed to be the general population.
The claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.