Scientific Opinion on the substantiation of health claims related to inositol
and cognitive function (ID 1588) pursuant to Article 13(1) of Regulation
(EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Inositol
cognitive function
health claims
myoinositol
1. Charakterystyka żywności / składnika
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Prawidłowe funkcje poznawcze
The food constituent that is the subject of the health claim is inositol which is a carbocyclic polyol that plays an important role as the structural basis for a number of secondary messengers in eukaryotic cells. It is found in many foods, in particular in cereals with high bran contents, nuts, beans, and in fruit. Inositol can be measured by established methods. Myoinositol is the most prominent naturally occurring form of inositol.
The Panel considers that the food constituent inositol, which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Prawidłowe funkcje poznawcze
The claimed effect is “cognitive and mental performance”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings cognitive and mental performance are both interpreted as cognitive function, which includes memory, attention (concentration), learning, intelligence and problem solving, which are well defined constructs and can be measured by validated psychometric cognitive tests.
The Panel considers that normal cognitive function is beneficial to human health.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Prawidłowe funkcje poznawcze
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Prawidłowe funkcje poznawcze
A total of 28 references were cited to substantiate the claimed effect. Two of these references were systematic reviews, six were narrative reviews, 14 reported on human studies, one provided a meta- analysis of human data, three reported on animal studies, and two were in-vitro studies.
The human studies could be broken down into those investigating the effect of inositol or myoinositol on patients with Alzheimer's disease and those investigating the effect of inositol or myoinsitol on patients suffering from depression, panic disorder, obsessive compulsive disorder, bipolar disorder, bulimia nervosa and binge eating and diabetic polyneuropathy. One human study reported on the effect of inositol on the development of retinopathy as a result of premature birth and a further study provided data on the long-term effects of extreme situational stress on sleep and dreaming.
Only two of the reviews considered endpoints relevant to cognitive function, but all of the studies reviewed were undertaken in patients with dementia and psychiatric disorders. The meta-analysis was conducted using data obtained from studies investigating inositol as a potential treatment in obsessive-compulsive disorder.
The Panel considers that the evidence provided does not establish that patients with Alzheimer's disease, depression, panic disorder, obsessive compulsive disorder, bipolar disorder, bulimia nervosa and diabetic polyneuropathy are representative of the general population with regard to cognitive function, or that results obtained in studies on patients with these diseases and relating to the treatment of their symptoms can be extrapolated to cognitive function in the general population.
All of the animal studies focused on the prevention of neural tube defects as a result of maternal diabetes, while the in vitro studies focused on the influence of inositol on signalling mechanisms in cells. The Panel notes that these studies provide little support for a claim on cognitive function.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of inositol and normal cognitive function.
Wnioski
On the basis of the data available, the Panel concludes that:
The food constituent inositol, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “cognitive and mental performance”. The target population is assumed to be the general population. Normal cognitive function is beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of inositol and normal cognitive function.