Scientific Opinion on the substantiation of health claims related to “wheat dextrin” and maintenance of normal blood pressure (ID 844, 1682),
maintenance of normal (fasting) blood concentrations of triglycerides (ID 844, 1682), maintenance of normal blood cholesterol concentrations (ID 844, 1682), reduction of post-prandial glycaemic responses (ID 845,
3096), increase in magnesium and/or calcium retention (ID 846, 3097), short chain fatty acid (SCFA) production in the bowel (ID 1681), decreasing
potentially pathogenic gastro-intestinal microorganisms (ID 843, 1681) and maintenance of normal bowel function (ID 843, 1680) 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:
Wheat dextrin
blood pressure
bowel function
calcium
cholesterol
gastro-intestinal microorganisms
health claims
magnesium
post-prandial glycaemic responses
retention
short chain fatty acids
triglycerides
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the claim is “wheat dextrin”.
Based on the information provided, the wheat dextrin that is the subject of the claim has a mean molecular weight of 5,344g/mol. The degree of polymerisation is from 15 to 18 glucose units of which 24 % in α-1,6 linkage (Pasman et al., 2006; Van Den Heuvel et al., 2004; Vermorel et al., 2004).
The Panel notes that the food constituent which is the subject of the health claims is a specific commercial preparation of wheat dextrin.
The Panel considers that the food constituent, wheat dextrin in the specific preparation, which is the subject of this opinion is sufficiently characterised in relation to the claimed effects.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Utrzymanie prawidłowego ciśnienia tętniczego (ID 844, 1682)
The claimed effect is “heart health”. 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 pressure.
Blood pressure is the pressure (force per unit area) exerted by circulating blood on the walls of blood
vessels. Elevated blood pressure, by convention 140 mmHg (systolic) and/or 90 mmHg (diastolic), may compromise the normal function of the arteries.
The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect.
2.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 844, 1682)
The claimed effect is “heart health”. 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. Excess calorie intake with a meal is converted to triglyceride and transported to the adipose tissue for storage. 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.
2.3. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 844, 1682)
The claimed effect is “heart health”. The Panel assumes 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.
2.4. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 845, 3096)
The claimed effect is “reduction of glycaemic response”. The Panel assumes that the target population is individuals willing to reduce their post-prandial glycaemic responses.
In the context of the proposed wordings, the Panel notes 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 is a normal physiological response that varies in magnitude and duration and 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). The evidence provided does not establish that decreasing post-prandial glycaemic responses in subjects with normal glucose tolerance is a beneficial physiological effect. However, it may be beneficial to subjects 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 the reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) may be a beneficial physiological effect.
2.5. Zwiększenie ilości magnezu i/lub wapnia w organizmie (ID 846, 3097)
The claimed effect is “mineral absorption”. 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 an increase in magnesium and/or calcium absorption and retention.
The Panel notes that magnesium and/or calcium absorption is generally not a limiting factor for magnesium and calcium retention.
The Panel considers that an increase in magnesium and/or calcium absorption leading to an increase in magnesium and/or calcium retention might be a beneficial physiological effect.
2.6. Produkcja krótkołańcuchowych kwasów tłuszczowych (SCFA) w przewodzie pokarmowym (ID 1681)
The claimed effect is “bowel health/SCFA production”. The Panel assumes that the target population is the general population.
The Panel assumes that the claimed effect refers to the production of short chain fatty acids (SCFA) in the bowel.
The Panel considers that the evidence provided does not establish that SCFA production in the bowel is a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “wheat dextrin” and a beneficial physiological effect related to SCFA production in the bowel.
2.7. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 843, 1681)
The claimed effects are “bowel health/digestive health/bowel movement” and “bowel health/SCFA production”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effects refer to changes in the number of gastro-intestinal microorganisms.
The numbers/proportions of bacterial groups that would constitute a “natural or healthy balance microflora” have not been established. Increasing the number of any groups of microorganisms is not considered to be a beneficial physiological effect. The Panel considers that the evidence provided does not establish that the claimed effect in the context of increasing the numbers of gastro-intestinal microorganisms is a beneficial physiological effect.
The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.
2.8. Utrzymanie prawidłowego funkcjonowania jelit (ID 843, 1680)
The claimed effect is “bowel health/digestive health/bowel movement”. 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 bowel regularity.
Changes in bowel habits within the normal range e.g. reduced transit time, increased frequency of bowel movements or increased bulk of stools might be considered as improved bowel function.
The Panel considers that maintenance of normal bowel function might be a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
3.1. Utrzymanie prawidłowego ciśnienia tętniczego (ID 844, 1682)
The references provided for the scientific substantiation of this claim addressed the effects of consuming different types of fibre and/or different fibre sources (fruits, vegetables, “whole grain”, guar gum, psyllium, etc.) on different health outcomes (e.g. coronary heart disease, blood lipids, blood glucose control), including blood pressure. None of the references provided addressed the effects of wheat dextrin consumption on blood pressure. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “wheat dextrin” and maintenance of normal blood pressure.
3.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 844, 1682)
The references provided for the scientific substantiation of this claim addressed the effects of consuming different types of fibre and/or different fibre sources (fruits, vegetables, “whole grain”, guar gum, psyllium, etc.) on different health outcomes (e.g. coronary heart disease, blood pressure, blood lipids, blood glucose control), including blood concentrations of triglycerides. None of the references provided addressed the effects of wheat dextrin consumption on blood concentrations of triglycerides. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “wheat dextrin” and maintenance of normal (fasting) blood concentrations of triglycerides.
3.3. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 844, 1682)
The references provided for the scientific substantiation of this claim address the effects of consuming different types of fibre and/or different fibre sources (fruits, vegetables, “whole grain”, guar gum, psyllium, etc.) on different health outcomes (e.g. coronary heart disease, blood pressure, blood lipids, blood glucose control), including blood cholesterol concentrations. None of the references provided addresses the effects of wheat dextrin consumption on blood cholesterol concentrations. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “wheat dextrin” and the maintenance of normal blood cholesterol concentrations.
3.4. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 845, 3096)
A total of nine references were provided for the substantiation of this claim. One was a reference to a conference contribution, two were references on prospective cohort studies on the association between the intake of cereal fibres, glycaemic load/index and the incidence of non-insulin dependent diabetes mellitus, one was a book chapter on different dietary fibres and five were references on randomised intervention studies on the effects of different sources of soluble dietary fibre (e.g. pea fibre, guar gum, alginate, psyllium) on post-prandial blood glucose and insulin concentrations. None of these studies were conducted using wheat dextrin. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “wheat dextrin” and reduction of post-prandial glycaemic responses.
3.5. Zwiększenie ilości magnezu i/lub wapnia w organizmie (ID 846, 3097)
Only one reference was provided for the substantiation of this claim.
Vermorel et al. (2004) performed a randomised, cross-over intervention study which investigated the effects of wheat dextrin on calcium, magnesium and zinc absorption and retention compared to dextrose (control) in 10 healthy young men. Wheat dextrin and dextrose at doses of about 100 g per day (consumed in six equal fractional doses per day in the context of a weight maintenance diet) were consumed by subjects for 11 days each (after a 20-day adaptation period on each diet with incremental doses of wheat dextrin and dextrose from 20 g per day until the target dose was reached) with a washout period of four weeks in between. Food intake was determined for 11 days using the duplicate meal method and faeces and urine were collected for 10 days for analysis. A statistically significant increase in magnesium absorption accompanied by a significant increase in urinary magnesium excretion and magnesium retention was observed for wheat dextrin compared to dextrose. No
significant differences were observed between treatments with respect to calcium absorption, urinary excretion or retention. The Panel notes the small number of subjects and the short duration of the study period.
In weighing the evidence, the Panel took into account that only one study reports an effect of wheat dextrin on magnesium (but not on calcium) retention in a small sample of subjects during a very short time, that no information is provided about the sustainability of the effect and that no evidence for a mechanism by which wheat dextrin 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 “wheat dextrin” and an increase in calcium and/or magnesium absorption leading to an increase in calcium and/or magnesium retention.
3.6. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 843, 1681)
Nine references were cited for the substantiation of the claim. None of these references evaluated the effect of wheat dextrin consumption on potentially pathogenic gastro-intestinal microorganisms. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “wheat dextrin” and decreasing potentially pathogenic gastro-intestinal microorganisms.
3.7. Utrzymanie prawidłowego funkcjonowania jelit (ID 843, 1680)
Nine references were cited for the substantiation of the claim. One reference was incompletely cited and two references were not accessible to the Panel despite efforts to retrieve them.
The paper by Satouchi et al. (1993) related to “indigestible dextrin from potato starch”, which is not wheat dextrin, the review by Schley and Field (2002) addressed immune-enhancing effects of dietary fibres and the study of Wisker et al. (1998) compared in vitro with in vivo fermentation of mixed diets. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Van den Heuvel et al. (2004), investigated the tolerance of increasing doses of commercially available wheat dextrin (0, 10, 30, 60 and 0, 15, 45, 80 grams per day) in 20 healthy male volunteers using a randomised placebo-controlled, multiple-dose double blind cross-over design. No significant effect on defecation frequency was observed at the proposed conditions of use.
Pasman et al. (2006) studied faecal and blood parameters, body weight, energy intake and colon microbiota, and monitored gastrointestinal discomfort in 48 male healthy subjects consuming either 22.5 gram maltodextrin, or 30 or 45 gram wheat dextrin daily for 4-5 weeks. No effect was found on dry and wet weight of the faeces and the effect on intestinal transit time and frequency of stools was not measured.
Finally, Vermorel et al. (2004) studied faecal output and tolerance, metabolisable energy and mineral absorption after wheat dextrin intervention. After a progressive adaptation of 18 days (from 20 to 100 grams per day), 10 male healthy volunteers received 100 grams wheat dextrin or dextrose for another 13 days using a cross-over design. A significant increase of both wet and dry faecal output was found but differences in the number of defecations were not significantly different. The Panel notes the small sample size of the study and that the dose studied was considerably higher than what is proposed in the conditions of use, both of which limit the value of the study as a source of data to substantiate the claimed effect.
In weighing the evidence, the Panel took into account that only one study reported an effect of wheat dextrin on stool weight in a small sample of subjects at a dose that was considerably higher than the
doses proposed in the conditions of use, while the two other human intervention studies provided did not show an effect on the outcomes which were related to the claimed effects.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “wheat dextrin” and maintenance of normal bowel function.
Wnioski
On the basis of the data presented, the Panel concludes that:
The specific preparation of wheat dextrin which is the subject of this opinion is sufficiently characterised in relation to the claimed effects.
Maintenance of normal blood pressure (ID 844, 1682)
The claimed effect is “heart health”. 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 pressure. Maintenance of normal blood pressure is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of “wheat dextrin” and maintenance of normal blood pressure.
Maintenance of normal (fasting) blood concentrations of triglycerides (ID 844, 1682)
The claimed effect is “heart health”. 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 “wheat dextrin” and maintenance of normal (fasting) blood concentrations of triglycerides.
Maintenance of normal blood cholesterol concentrations (ID 844, 1682)
The claimed effect is “heart health”. 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 cholesterol concentrations. Maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of “wheat dextrin” and maintenance of normal blood cholesterol concentrations.
Reduction of post-prandial glycaemic responses (ID 845, 3096)
The claimed effect is “reduction of glycaemic response”. The target population is assumed to be individuals willing 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 “wheat dextrin” and reduction of post-prandial glycaemic responses.
Increase in magnesium and/or calcium retention (ID 846, 3097)
The claimed effect is “mineral absorption”. 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 an increase in magnesium and/or calcium absorption and retention. An increase in
magnesium and/or calcium absorption leading to an increase in magnesium and/or calcium retention might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of “wheat dextrin” and an increase in magnesium and/or calcium absorption leading to an increase in magnesium and/or calcium retention.
Short chain fatty acid (SCFA) production in the bowel (ID 1681)
The claimed effect is “bowel health/SCFA production”. The target population is assumed to be the general population. The evidence provided does not establish that short chain fatty acid (SCFA) production in the bowel is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of “wheat dextrin” and a beneficial physiological effect related to SCFA production in the bowel.
Decreasing potentially pathogenic gastro-intestinal microorganisms (ID 843, 1681)
The claimed effects are “bowel health/digestive health/bowel movement” and “bowel health/SCFA production”. The target population is assumed to be the general population. Decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of “wheat dextrin” and decreasing potentially pathogenic gastro-intestinal microorganisms.
Maintenance of normal bowel function (ID 843, 1680)
The claimed effect is “bowel health/digestive health/bowel movement”. The target population is assumed to be the general population. Maintenance of normal bowel function might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of “wheat dextrin” and maintenance of normal bowel function.
