V0137 and ‘a reduced loss of cognitive function’: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006: (Scientific Opinion)
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V0137 and ‘a reduced loss of cognitive function’: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 : (Scientific Opinion). / EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).
In: E F S A Journal, Vol. 14, No. 8, 4539, 05.08.2016.Research output: Contribution to journal › Journal article › Commissioned › peer-review
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TY - JOUR
T1 - V0137 and ‘a reduced loss of cognitive function’: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
T2 - (Scientific Opinion)
AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
AU - Sjödin, Anders Mikael
N1 - EFSA 2016 4539
PY - 2016/8/5
Y1 - 2016/8/5
N2 - Following an application from Pierre Fabre Medicament, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on thescientific substantiation of a health claim related to V0137, a ‘DHA-enriched fish oil’, and ‘helps to slow the age-related cognitive decline in domains such as memory and executive function’. The food, V0137, which is the subject of the health claim, is sufficiently characterised. The Panel considers that a reduced loss of cognitive function is a beneficial physiological effect. The applicant submitted five human studies for the substantiation of the health claim, four of which were carried out with foods other than V0137. No conclusions could be drawn from these four studies for the scientific substantiation of the claim. The remaining study was a multicentre, randomised, placebo-controlled, 3-years parallel trial in 1,680 subjects of at least 70 years and at risk of cognitive decline. The subjects were distributed to the four following study groups: (i) V0137 + multidomain intervention (MDI; physical and cognitive exercise, nutrition recommendations); (ii) V0137 without MDI; (iii) placebo + MDI; (iv) placebo without MDI. The primary endpoint of the study was a change incognitive function, as assessed by a composite cognitive score. There were no statistically significant differences between the study groups for changes in the composite cognitive score at 36 months. The Panel concludes that a cause and effect relationship has not been established between the consumption of V0137 and a reduced loss of cognitive function.
AB - Following an application from Pierre Fabre Medicament, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on thescientific substantiation of a health claim related to V0137, a ‘DHA-enriched fish oil’, and ‘helps to slow the age-related cognitive decline in domains such as memory and executive function’. The food, V0137, which is the subject of the health claim, is sufficiently characterised. The Panel considers that a reduced loss of cognitive function is a beneficial physiological effect. The applicant submitted five human studies for the substantiation of the health claim, four of which were carried out with foods other than V0137. No conclusions could be drawn from these four studies for the scientific substantiation of the claim. The remaining study was a multicentre, randomised, placebo-controlled, 3-years parallel trial in 1,680 subjects of at least 70 years and at risk of cognitive decline. The subjects were distributed to the four following study groups: (i) V0137 + multidomain intervention (MDI; physical and cognitive exercise, nutrition recommendations); (ii) V0137 without MDI; (iii) placebo + MDI; (iv) placebo without MDI. The primary endpoint of the study was a change incognitive function, as assessed by a composite cognitive score. There were no statistically significant differences between the study groups for changes in the composite cognitive score at 36 months. The Panel concludes that a cause and effect relationship has not been established between the consumption of V0137 and a reduced loss of cognitive function.
KW - Faculty of Science
KW - V0137
KW - Cognition
KW - Memory
KW - Health claims
U2 - 10.2903/j.efsa.2016.4539
DO - 10.2903/j.efsa.2016.4539
M3 - Journal article
VL - 14
JO - E F S A Journal
JF - E F S A Journal
SN - 1831-4732
IS - 8
M1 - 4539
ER -
ID: 188267540