There were three studies in the EPIF dossier, two of which were unpublished intervention trials, but EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said one of these was uncontrolled and therefore not reliable. The published study did not use ‘Wheat Polar Lipid Extract’.
‘Wheat Polar Lipid Extract’ is a powder composed of more than 95% lipids like glycosyl ceramides and ceramides, digalactosyldiglycerides (DGDG), phospholipids, monogalactosyldiglycerides (MGDG) and glycosylated sterols.
The NDA gave more credence to the other unpublished clinical trial which was conducted on 60 healthy Caucasian women aged between 30 and 60 years.
They consumed either 30 milligrams per day of Wheat Polar Lipid Extract which converted to 1.8mg/day of ceramides and 15mg/day of DGDG; a wheat oil product or a placebo.
The primary endpoint was water holding capacity with skin elasticity, skin smoothness, skin roughness, skin wrinkles as secondary endpoints along with,“a measure of the water barrier function of the skin, the trans-epidermal water loss (TEWL).”
“The Panel considers that measures of TEWL can be used as scientific evidence for a claim on protection of the skin against dehydration and that measures of the water-holding capacity of skin may be used as supportive evidence,” the NDA wrote.
“Lacks plausibility”
A stop-the-clock procedure saw EPIF reanalyse the data using different methods which found some significant results for TEWL and skin water-holding capacity but this was compromised by the study design and so the overall results were discounted.
“The Panel notes that the design of this study would have greatly limited the possibility of detecting an effect of Wheat Polar Lipid Extract on skin hydration as the dose of ceramides and DGDG provided by Wheat Polar Lipid Extract is only a small fraction (about 10 %) of the quantity which would be consumed in the background diet by subjects eating typical amounts of wheat-derived food products.”
“Therefore, the Panel considers that the outcome of the study lacks plausibility given the limitations in the design of the study.”
Causality had not therefore been demonstrated.
Extraction Purification Innovation France (EPIF) submitted the claim that targeted ‘healthy adults’ that may have suffered skin issues due to, “hot, cold or windy weather, low environmental humidity, or excessive cleansing.”
