Laboratoire LESCUYER Achieves Article 14 Claim for LIMICOL
7 Nov 2013 --- Laboratoire LESCUYER has obtained a positive opinion from EFSA for a health claim under Article 14 for its product LIMICOL. It is the first time a dietary supplement has ever received a favourable opinion for such a health claim. This is a real landmark in the European market and makes Laboratoire LESCUYER a true pioneer in its field.
Unique proven efficacy recognized by a highly demanding authority Obtaining EFSA recognition is a lengthy process requiring extensive work. EFSA not only represents the highest European authority for food safety but it is also one of the most demanding panels of experts in Nutrition in the world. Hence, a positive opinion from EFSA is equivalent to the very highest scientific recognition at a European level.
By responding favourably, EFSA scientifically recognizes the health benefits of LIMICOL: LIMICOL "reduces blood LDL-cholesterol concentrations. High LDL-cholesterol is a risk factor in the development of coronary heart disease". An unprecedented and exclusive health claim It is the first dietary supplement to benefit from the protection of proprietary data relating to a disease risk claim. Once final approval is received from the European Commission, Laboratoire LESCUYER will be the only one to have the right to state this claim on its unique, patented formula.
Rigorous scientific requirements that deserve this recognition Obtaining this positive opinion is the fruit of 5 years of research that allowed Laboratoire LESCUYER to submit a very complete scientific dossier, including the results of 3 proprietary clinical studies to EFSA.
The medical scientific team at Laboratoire LESCUYER worked closely with external contributors (biochemists, clinicians, toxicologists, biostatisticians) to produce all the elements for the health claim application. Independent research groups conducted the 3 clinical trials respecting the highest scientific standards: double-blind, placebo-controlled randomized studies on a total of 184 volunteers. These studies2,3,4 were published in international peer-reviewed scientific journals, an assurance of reliability concerning the findings put forward.
Thanks to this research, LIMICOL is, today, the only exclusive patented dietary supplement with efficacy officially recognized by Europe.
On the market since 2008, LIMICOL is a dietary supplement associating plant extracts, red yeast rice and vitamins, a total of 8 ingredients acting synergistically to naturally reduce excess cholesterol. The LIMICOL formula combines artichoke extract, red yeast rice, sugar-cane derived policosanols, garlic extract, OPC from maritime pine bark as well as vitamins B2, B3 and E. Proven efficacy through 3 clinical studies The efficacy of LIMICOL in cholesterol reduction has been demonstrated by 3 clinical studies conducted on a total of 184 volunteers with excess cholesterol. From the 1st month, the daily intake of 3 LIMICOL tablets significantly reduced the total cholesterol levels by 15.3%2, the LDL-cholesterol concentrations by 21.4%2 and the Apo-B rate by 15.4%3. These markers were then stabilized over the next 3 months. After 4 months of supplementation, there was also a decrease of 12.2%2 in triglycerides. Guaranteed high tolerance The efficacy and singularity of the LIMICOL formula is based on the synergistic action of selected ingredients and on the precise dosage of each of these ingredients. Laboratoire LESCUYER deliberately chose to incorporate 2 mg of monacolin K (an active substance from red yeast rice) per recommended daily dose while still maintaining optimal efficacy. This lower than normal dosage avoids the muscular discomfort that generally results from taking red yeast rice. The excellent tolerance of LIMICOL was confirmed by the 3 clinical studies.
This feature is provided by Nutrition Insight’s sister website, Food Ingredients First.
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