Scientific Opinion on the substantiation of health claims related to alpha cyclodextrin and reduction of post prandial glycaemic responses (ID 2926, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a health claim pursuant to Article 13.1 of Regulation (EC) No 1924 in the framework of further assessment related to alpha-cyclodextrin and reduction of post-prandial glycaemic responses. The food constituent that is the subject of the claim, alpha-cyclodextrin, is sufficiently characterised. The claimed effect, reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased), may be a beneficial physiological effect. The proposed target population is individuals who wish to reduce their post-prandial glycaemic responses. In weighing the evidence, the Panel took into account that two intervention studies showed a significant effect of alpha-cyclodextrin added to starch on post-prandial glycaemic responses without disproportionally increasing post-prandial insulinaemic responses, that one study on alpha-cyclodextrin added to sucrose did not show an effect on post-prandial glycaemic responses, and that there is some evidence in support of a plausible mechanism by which alphacyclodextrin could exert the claimed effect. On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of alpha-cyclodextrin with starch-containing meals and reduction of post-prandial glycaemic responses. The Panel considers that in order to obtain the claimed effect, at least 5 g of alpha-cyclodextrin per 50 g of starch should be consumed. The target population is adults who wish to reduce their post-prandial glycaemic responses. SUMMARYFollowing a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924. The Commission has agreed with EU Member States that a certain number of Article 13 health claims would be eligible for further assessment by EFSA in order to be able to take a final decision on whether or not to include these claims in the list of permitted health claims. This opinion addresses the scientific substantiation of a health claim in relation to alpha-cyclodextrin and reduction of post-prandial glycaemic responses. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims, references that EFSA has received from Member States or directly from stakeholders, and the additional information provided by the competent Authority of the Netherlands for further assessment of this claim.The food constituent that is the subject of the health claim is alpha-cyclodextrin. The Panel considers that alpha-cyclodextrin is sufficiently characterised.The claimed effect, which is eligible for further assessment, is reduction of post-prandial glycaemic responses. The proposed target population is individuals who wi...

The effect of alpha-cyclodextrin on postprandial glucose excursions, a systematic meta analysis Alpha-cyclodextrin and Blood Glucose

“…In summary, all comparisons, even at the 2 g dose, showed lower glucose profiles with αCD and only one comparison (at the 2 g dose) [4] showed higher (but not significant) insulin levels with αCD. Hence, the efficacy of αCD when added to a high-carb (rice or bread) meal in young adults is dose-dependent [19], with doses from 5 g/50 g proven effective, as concluded by the EFSA in 2012. The αCD’s mechanism of action seems not to involve an increase of insulin production.…”

“…Bär, Diamantis, et al . (2020) [5] – in PubMed, but not as a “clinical trial”, unpublished protocol (2002) and report (2002) quoted in EFSA (2012) [19] some results also described in Schmid (2004) US 2004/0161526 A1 (Wacker, abandoned) [20]…”

“…Diamantis, Bär (unpublished 2002 protocol and report, quoted in EFSA (2012) [19], subsequently published as Bär, Diamantis, et al (2020) [5]): 12 healthy male adults age 23-24 consumed white bread (50 g starch) with 0 or 10 g αCD dissolved in 250 mL drinking water. Postprandial glucose and insulin were measured.…”

Cyclodextrin Monomers and Polymers for Drug Activity Enhancement

“…The effect of γ-CD in the feed of mice was studied recently, the data indicated that dietary γ-CD leads to increased endurance-parameters such as traversed distance per night and general activity were increased; however, clear biochemical evidence was not found [54]. Finally, the EFSA permitted α-CD to be described as a dietary fiber, suitable for reducing postprandial glycemic responses due to its competitive inhibition of α-amylase [55].…”

Encapsulated EVOO Improves Food Safety and Shelf Life of Refrigerated Pre-Cooked Chicken Nuggets

“…The Codex also includes the Acceptable Daily Intake (ADI) for β-CD of 5 mg/kg per day (re-evaluated without modifications in 2016), although α-CD and γ-CD still do not have a specific ADI due to JECFA's favorable toxicological data [15]. α-CD is considered as a prebiotic and also has other health-promoting properties like a promoting effect on sugar and fat metabolism [16,17]. α-CD is very stable under common food processing treatments with thermal degradation occurring at 297 • C [18,19].…”