In a new health claim opinion EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found data lacking to back Swiss firm Vifor’s assertion that its ‘eye Q’ supplement could boost reading capacity in children between the ages of three and 13.
Vifor submitted four studies under the children's claim-focused article 14 of the nutrition and health claims regulation (NHCR) to back its claim that eye Q could facilitate “improvement in reading ability.“
The NDA found flaws in three of them including lack of a control and lack of testing for multiplicity of outcomes. They were all dismissed.
One of the studies used EFSA-backed measures like the Wechsler Objective Reading Dimensions (WORD) test to determine if the reading ability of 241 British 6-12 year-olds from diverse backgrounds improved versus placebo over six months.
For three months, half of the children were given eye Q, half an olive oil solution. In the next three months all children were given eye Q, a design the NDA said meant the second period findings were not assessable for a lack of control. In dismissing its overall findings the NDA added the trial failed to address interaction between intervention and schools on reading ability in its statistical analysis.
Another study used measures like the Wide Range Achievement Test: Fourth Edition (WRAT4) to assess changes in reading ability of 154 9-10 year olds given eye Q or placebo with the same 3+3 months design the NDA again dismissed.
In the fourth study – a double-blind, placebo-controlled parallel intervention – 408 rural Australian children aged 3-13 were given either six eye Q capsules or an olive oil placebo for 20 weeks. A second phase where they all consumed eye Q was dismissed by the NDA for the same reasons as above.
But even in the assessable first 20 weeks the NDA said there was no significant difference between the eye Q and placebo groups.
It therefore rejected the proposition.
The NDA opinion is here.
Dose
According to Vifor children need to consume 558 mg of eicosapentaenoic acid (EPA), 174 mg of docosahexaenoic acid (DHA) and 60 mg of gamma-linolenic acid (GLA) – a ratio of 9:3:1 – to achieve the desired effect.
Its formulations typically arrive in:
- capsules or chewable capsules: 93 mg EPA, 29 mg DHA, 10 mg GLA per capsule;
- triple strength capsules: 279 mg EPA, 87 mg DHA, 30 mg GLA per capsule;
- liquid formulation: 186 mg EPA, 58 mg DHA, 20 mg GLA per 5 ml.
Eye Q has had several cognitive claims rejected under the NHCR over the years, dating back to 2008, when the new law began to take effect across the EU.