FDA staat twee claims toe voor een voedingssupplement!*

De FDA (Food and Drug Aministration in de USA) heeft begin dit jaar toegestaan dat voor het voedingssupplement PS  (phospatidylserine) twee gezondheidsclaims mogen worden gebruikt. De gezondheidsclaims zijn: Bij ouderen kan PS  mogelijk het risico op geheugenproblemen verminderen en de kans op dementie verkleinen.

The information contained in this week’s newsletter you probably did not read about in your local newspaper or hear on the radio or television. As a neurologist who treats dementia patients on a daily basis, this is monumental. The Food and Drug Administration (FDA) allowed two health claims for a nutrient called phosphatidylserine (PS). The first claim is that PS may reduce the risk of cognitive dysfunction in the elderly with a second claim being that PS may reduce the risk of dementia in the elderly.These health claims approved by the FDA should not be taken lightly. A petition was filed with the FDA almost one year ago and I would assume that several months of review of the medical literature was done by the FDA before this health claim was approved. Bear in mind that most vitamins and nutrients sold do not carry any FDA health claims. Products must meet the FDA’s requirements that they are safe and lawful at the levels needed to justify a health claim.So what were some of the studies that encouraged the FDA toward this authorization? There have been more than two dozen studies that have been done to date, many of which have demonstrated benefit for this important nutrient. Many of the studies were of a double-blinded nature. For example, in one study of 51 patients meeting the clinical criteria for probable Alzheimer’s disease, patients received either twelve weeks of PS 3 times daily or a placebo. At the end of the three month trial, those treated with PS improved on several cognitive measures relative to those who were administered the placebo. Differences between treatment groups were most apparent among patients with less severe cognitive impairment. In another study of 149 patients with age-associated memory impairment, those treated for twelve weeks with PS 3 times daily (vs placebo) improved in performing tasks related to learning and memory tasks of daily life. This study published in the prestigious journal Neurology concluded that the results suggest that this compound may be a promising candidate for treating memory loss in later life. A large multi-center study was performed on PS in Italy approximately ten years ago. This double-blinded study involved 494 elderly patients with moderate to severe cognitive decline. Half of the group was treated with PS daily for a six month period. Patients were examined just before starting the therapy and at three and six months thereafter. Compared to the placebo group, there was statistical significant improvement in the treated group in both terms of behavioral and cognitive parameters. In addition, clinical evaluation in laboratory testing demonstrated that PS was well tolerated. Based on the blessing from the FDA, I will now freely recommend this nutrient to all of my senior patients with declining memory and early dementia. There are literally millions of patients in this category. It would seem that taking PS before memory impairment begins should have some beneficial effect, although this has not clearly been shown in any clinical trials. (2003) 

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