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Scientific Opinion on the substantiation of a health claim related to Catalgine® bouffées de chaleur and contributes to the reduction in the number of hot flushes pursuant to Article 13(5) of Regulation (EC) No 1924/2006

EFSA Journal 2010; 8(1):1422 [10 pp.]. doi:10.2903/j.efsa.2010.1422
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen. Acknowledgment The Panel wishes to thank the members of the Working Group on claims for the preparation of this opinion: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Laboratoire vie et santé Question number: EFSA-Q-2009-00852 Adopted: 04 December 2009 Published: 13 January 2010 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Following an application from Laboratoire Vie et Santé submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim based on newly developed science and including proprietary data related to Catalgine® and contributes to the reduction in the number of hot flushes. Catalgine® bouffées de chaleur (also called OM3® menopause) is a dietary supplement made with concentrated wild fish oil that is sufficiently characterised. The reduction in the frequency of episodes of hot flushes is considered beneficial to the health of peri- and post-menopausal women. Two publications (three studies) were identified by the applicant as being pertinent to the claim. Two studies were uncontrolled with respect to the supplement. The third was a post-hoc analysis of a subsample of women participating in a randomised, placebo controlled intervention evaluating the effects of Catalgine® on psychological distress. A number of weaknesses in this study, including unsuccessful blinding and limited power, greatly limit its value as a source of data to substantiate the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Catalgine® bouffées de chaleur and the reduction in the frequency of episodes of hot flushes.

© European Food Safety Authority, 2010

Summary

Following an application from Laboratoire Vie et Santé submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Catalgine® and contributes to the reduction in the number of hot flushes.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data.

The food constituent that is the subject of the health claim is Catalgine® bouffées de chaleur (also called OM3® menopause). The product is described as a dietary supplement made with concentrated wild fish oil from sardines and anchovies. The amount of fish oil per capsule is 500 mg with total n-3 fatty acids being about 90 % by weight, eicosapentaenoic acid (EPA) about 73 % (688.6 mg/g) and docosahexaenoic acid (DHA) about 13 % (123.4 mg/g) expressed as ethyl esters. The Panel considers that the food constituent, Catalgine® bouffées de chaleur, which is the subject of the health claim, is sufficiently characterised.

The claimed effect is “management of vasomotor symptoms, particularly hot flushes”. The target population is middle aged women prone to hot flushes during the peri- and the post-menopausal period. From the proposed wording, the Panel assumes that the claimed effect relates to the reduction in the number of episodes of hot flushes. The Panel considers that the reduction in the frequency of episodes of hot flushes is beneficial to the health of peri- and post-menopausal women.

Two publications were identified by the applicant as being pertinent to the claim. The first publication reported on two double-blinded randomised controlled trials (RCT) with cross-over design of 24 week duration. The Panel notes that no conclusions can be drawn from these studies to substantiate the claim as they were uncontrolled with respect to the PUFA supplement, which also differed substantially from the PUFA profile of the product that is the subject of the health claim.

The second publication reported on a double-blinded RCT with parallel design in middle aged women suffering from hot flushes (HF) who were part of a larger clinical trial aimed at evaluating the effects of OM3® (identical to Catalgine® bouffées de chaleur) on psychological distress. A total of 29 women (n=14 OM3® group, n=15 placebo) did not have any HF symptoms during the study and were excluded from the secondary post-hoc analysis, which included data from 43 (OM3® group) and 39 (placebo group) women, respectively. Secondary outcomes of the study were changes in HF frequency (number of HF/d), HF intensity, HF score (frequency x intensity), and changes in the proportion of HF responders defined as a reduction in HF frequency of 50 % or more. HF frequency and intensity were reported by means of a self-administered questionnaire. A significantly higher percentage of women in the OM3® group than in the placebo group declared a fish taste of the capsules (46.5 % vs 5.1 %). After 8 weeks of supplementation, HF frequency and HF score decreased significantly in the supplemented group compared to placebo. The odds of being a responder among those taking the supplement were 2.7 times greater than among those taking placebo. Changes in HF intensity were not significantly different between the groups. Post-hoc power analysis indicated a power of 66 % to detect the observed difference of 1.1 HF/d between groups.

The Panel notes a number of weaknesses in this study: a significantly higher percentage of women in the OM3® group declared a fish taste of the capsules compared to the placebo group indicating a failure in the subjects’ blinding, which is a major drawback for self-reported outcomes such as HF frequency and intensity; the study reported a post-hoc analysis on a secondary outcome in a sub-group of women who were selected only post-randomisation on the basis of suffering from HF. The Panel considers that the significant weaknesses of this study greatly limit its value as a source of data to substantiate the claimed effect.

The Panel concludes that a cause and effect relationship has not been established between the consumption of Catalgine® bouffées de chaleur and the reduction in the frequency of episodes of hot flushes.

Keywords

Catalgine® bouffées de chaleur, eicosapCatalgine® bouffées de chaleur, eicosapentaenoic acid, docosahexaenoic aentaenoic acid, docosahexaenoic acid, n-3 polyunsaturated fatty acids, hot flashes, peri-menopausal women, post-menopausal women, health claims.