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Scientific Opinion on the substantiation of health claims related to alpha lipoic acid and protection of body lipids from oxidative damage (ID 1434, 3134), maintenance of normal blood cholesterol concentrations (ID 3134), increased beta-oxidation of fatty acids (ID 3134), maintenance of normal blood glucose concentrations (ID 1435, 3162), and "regeneration of genes, regeneration of gene transcription and the influence to activity NF kappa B" (ID 3133) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

EFSA Journal 2010; 8(2):1474 [18 pp.]. doi:10.2903/j.efsa.2010.1474
  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 for the preparation of this opinion: The members of the Working Group on Claims : 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. The membres of the Claims Sub-Working Group on Cardiovascular Health/Oxidative Stress: Antti Aro, Marianne Geleijnse, Marina Heinonen, Ambroise Martin, Wilhem Stahl and Henk van den Berg. Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2008-2171 , EFSA-Q-2008-2172 , EFSA-Q-2008-3865 , EFSA-Q-2008-3866 , EFSA-Q-2008-3894 Adopted: 21 December 2009 Published: 25 February 2010 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

No abstract available

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to alpha-lipoic acid and the following claimed effects: protection of body lipids from oxidative damage, maintenance of normal blood cholesterol concentrations, increased beta-oxidation of fatty acids, maintenance of normal blood glucose concentrations, “regeneration of genes, regeneration of gene transcription and the influence to activity NF kappa B”. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.

The food constituent that is subject of the health claims is alpha-lipoic acid. The Panel considers that alpha-lipoic acid is sufficiently characterised.

Protection of body lipids from oxidative damage

The claimed effects are “antioxidant properties” and “fat metabolism”. The target population is assumed to be the general population. The Panel assumes that the claimed effects relate to protection of body lipids from oxidative damage caused by free radicals. The Panel considers that protection of body lipids from oxidative damage may be a beneficial physiological effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-lipoic acid and the protection of body lipids from oxidative damage.

Maintenance of normal blood cholesterol concentrations

The claimed effect is “fat metabolism”. The target population is assumed to be the general population. In the context of the proposed wording “might also help to keep normal level of blood cholesterol”, the Panel assumes that the claimed effect relates to the maintenance of normal blood cholesterol concentrations. The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-lipoic acid and the maintenance of normal blood cholesterol concentrations.

Increased beta-oxidation of fatty acids

The claimed effect is “fat metabolism”. The target population is assumed to be overweight subjects in the general population who wish to reduce their fat mass. In the context of the proposed wordings, the Panel assumes that the claimed effect relates to an increased beta-oxidation of fatty acids leading to a reduction in body fat mass. The Panel considers that an increased beta-oxidation of fatty acids leading to a reduction in body fat mass may be a beneficial physiological effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-lipoic acid and an increased beta-oxidation of fatty acids leading to a reduction in body fat mass.

Maintenance of normal blood glucose concentrations

The claimed effects are “metabolism of carbohydrates” and “metabolism of glucose”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effect relates to the long-term maintenance or achievement of normal blood glucose concentrations. The Panel considers that long-term maintenance of normal blood glucose concentrations is a beneficial physiological effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-lipoic acid and long-term maintenance of normal blood glucose concentrations.

“Regeneration of genes, regeneration of gene transcription and the influence to activity NF-kappa B”

The claimed effect is “regeneration of genes, regeneration of gene transcription and the influence to activity NF-kappa B”. The Panel assumes that the target population is the general population.

“Regeneration of genes, regeneration of gene transcription and the influence to activity NF-kappa B” is not sufficiently defined, no more details were provided in the proposed wording, and the only reference submitted was unrelated to the claimed effect. The Panel considers that the claimed effect “regeneration of genes, regeneration of gene transcription and the influence to activity NF-kappa B” is too unspecific for a scientific evaluation.

The Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-lipoic and “regeneration of genes, regeneration of gene transcription and the influence to activity NF-kappa B”.
 

Keywords

Alpha-lipoic acid, oxidative damage, cholesterol, beta-oxidation, fatty acids, blood glucose, regeneration of genes, regeneration of gene transcription, NF-kappa B activity, health claims