A health claim related to improved cognitive performance for a creatine supplement has been rejected by the UK Nutrition and Health Claims Committee (UKNHCC).
Germany’s Alzchem Trostberg was seeking authorization for a function health claim based on newly developed scientific evidence pursuant to Article 13(5) of retained EU Regulation No. 1924/2006. Applicable to its Creavitalis (creatine monohydrate) supplement ingredient, the proposed wording of the claim is, “Daily creatine supplementation can contribute to improved cognitive function.”
The quantity of creatine required to obtain the claimed effect is 3g per day, according to Alzchem, with the target population healthy individuals aged 18 years and above.
Creavitalis features in the Livadur supplement marketed to German consumers by Alzchem subsidiary Suppliva, while the ingredient is also present in products offered by Sweden’s Greatlife Group AB, Austria’s BP Nutrition and Germany’s Raab Vitalfood, amongst others.
Alzchem has submitted the same health claim for authorization by the European Commission for use across the EU. EFSA recently put the application out to consultation in order to identify whether other relevant scientific data, studies and other information is available to support the claim.
No Cause-And-Effect Relationship
UKNHCC – which took over from EFSA in reviewing health claims following the UK’s exit from the EU – said Alzchem’s application failed to establish a cause-and-effect relationship between the consumption of ≤3g per day of creatine and improved cognitive function.
Alzchem identified 10 randomized controlled trials it said were pertinent to the proposed claim, however UKNHCC discounted eight of these as they used doses in excess of 3g creatine. Another trial was disregarded as it had not been demonstrated that the results – obtained in Muay Thai female athletes exercising to exhaustion – could be extrapolated to the target group, i.e. the general population.
The one RCT accepted by UKNHCC as pertinent to the claim was a double-blind placebo-controlled study in which 22 participants were randomly assigned to 2.2g of encapsulated creatine supplements or placebo for 6 weeks. Participants completed a range of neurocognitive tests pre- and post-supplementation, including reaction time, logical reasoning, mathematical processing and memory recall.
The authors reported no significant change between groups from pre- to post-supplementation for any of the cognitive tests. As a result, UKNHCC judged that the study did not provide the evidence required to substantiate Alzchem’s application.
Fourth Rejection
Alzchem’s health claim was the fourth reviewed by UKNHCC, and the fourth it has rejected.
The committee recently turned down a request to modify an authorized health claim by lowering the dose to achieve the claimed effect. Relating to the health claim, “Consumption of beta-glucans from oats or barley contributes to the reduction of the glucose rise after a meal,” PepsiCo International sought to lower the dose required from 4g to “at least 2g.”
In January last year, UKNHCC refused the health claim “clinically proven in assisting healthy blood glucose levels” in the target population of type 2 diabetics for Ascarit’s white mulberry-based dietary supplement. (Also see "UK Rejects Blood Glucose Health Claim For White Mulberry Supplement" - HBW Insight, 25 January, 2023.)
Assessing its first application in 2021, the committee gave a negative opinion to an Article 13(5) claim submitted by Alliance Pharma. It concluded that there was insufficient evidence to establish a cause and effect relationship between the consumption of 10mg lutein, 2mg zeaxanthin, 10mg meso-zeaxanthin together (the Macushield Original dietary supplement) and improved visual performance measured by contrast sensitivity.
