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A recent study published by the British Medical Journal<ref>[http://www.bmj.com/cgi/content/full/bmj.39231.599815.55v1 Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial - Hickson et al., 10.1136/bmj.39231.599815.55 - BMJ<!-- Bot generated title -->]</ref> suggests that the product could help to avoid antibiotic associated diarrhea and to limit ''[[Clostridium difficile]]'' infections in elderly patients, information that received some media coverage in the UK.<ref>[http://www.thesun.co.uk/sol/homepage/news/article239462.ece Actimel drinks stop superbug | The Sun |HomePage|News<!-- Bot generated title -->]</ref> In 2008 some British hospitals decided to use the product as part of the patient’s diet to fight the dangerous spread of ''C. difficile'' superbug.<ref>[http://www.dailymail.co.uk/pages/live/articles/health/dietfitness.html?in_article_id=512206&in_page_id=1798&in_page_id=1798&expand=true Doctors unveil latest weapon against hospital superbugs - drinking probiotic yoghurt | Mail Online<!-- Bot generated title -->]</ref>
A recent study published by the British Medical Journal<ref>[http://www.bmj.com/cgi/content/full/bmj.39231.599815.55v1 Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial - Hickson et al., 10.1136/bmj.39231.599815.55 - BMJ<!-- Bot generated title -->]</ref> suggests that the product could help to avoid antibiotic associated diarrhea and to limit ''[[Clostridium difficile]]'' infections in elderly patients, information that received some media coverage in the UK.<ref>[http://www.thesun.co.uk/sol/homepage/news/article239462.ece Actimel drinks stop superbug | The Sun |HomePage|News<!-- Bot generated title -->]</ref> In 2008 some British hospitals decided to use the product as part of the patient’s diet to fight the dangerous spread of ''C. difficile'' superbug.<ref>[http://www.dailymail.co.uk/pages/live/articles/health/dietfitness.html?in_article_id=512206&in_page_id=1798&in_page_id=1798&expand=true Doctors unveil latest weapon against hospital superbugs - drinking probiotic yoghurt | Mail Online<!-- Bot generated title -->]</ref>


More research is going on to determine the effectiveness, or otherwise, of this product in reducing the occurrence of more common illnesses in children attending daycare centers in the US. <ref>[http://www.clinicaltrials.gov/ct2/show/NCT00356382?term=dannon&rank=1 Decreasing Rates of Illness in Kids (DRINK) - Full Text View - ClinicalTrials.gov<!-- Bot generated title -->]</ref> This trial is listed by the US government website www.clinicaltrials.gov<ref>[http://www.clinicaltrials.gov Home - ClinicalTrials.gov<!-- Bot generated title -->]</ref> where clinical trials have to be registered prior to their start, in a move to increase overall credibility when studies are financially sponsored by the drug (or food) manufacturer as in this case (proponents of a registry argue that the results of clinical trials with negative results are often not published by the sponsor of the study). The details recorded there state that this study was completed in June 2007 but according to its listing the findings have not yet been published.
More research is going on to determine the effectiveness, or otherwise, of this product in reducing the occurrence of more common illnesses in children attending daycare centers in the US. <ref>[http://www.clinicaltrials.gov/ct2/show/NCT00356382?term=dannon&rank=1 Decreasing Rates of Illness in Kids (DRINK) - Full Text View - ClinicalTrials.gov<!-- Bot generated title -->]</ref> This trial is listed by the US government website [http://clinicaltrials.gov clinicaltrials.gov] <ref>[http://www.clinicaltrials.gov Home - ClinicalTrials.gov<!-- Bot generated title -->]</ref> where clinical trials have to be registered prior to their start, in a move to increase overall credibility when studies are financially sponsored by the drug (or food) manufacturer as in this case (proponents of a registry argue that the results of clinical trials with negative results are often not published by the sponsor of the study). The details recorded there state that this study was completed in June 2007 but according to its listing the findings have not yet been published.


==Debates surrounding health claims on probiotic foods==
==Debates surrounding health claims on probiotic foods==

Revision as of 02:59, 30 May 2010

First launched in Europe in 1994, Actimel (also known as DanActive in the United States and Canada) is a 'probiotic' yoghurt-type drink produced by the French company Danone. It is sold in 100ml bottles, typically as an 8, 6 or 4 pack, but more recently as a 12 or 16 pack. The main claimed benefit of Actimel is the strengthening of the body's natural defences through the use of patented bacterial culture called Lactobacillus casei DN-114001, marketed as Lactobacillus casei Defensis or Immunitas(s). Each bottle is claimed to contain 10 billion of these bacteria.[1] In addition Actimel contains the traditional yoghurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus salivarius subsp. thermophilus.

After the introduction of Yakult in Europe in 1993 several other companies including Danone responded releasing their own L. casei based products. Since 1994, L. casei based yogurts have become a common product in West European supermarkets.

Actimel earned over €1400 million (US$1.8 billion) in retail sales in 2006 [2] and can be found in more than 20 European countries as well as in South America and the Middle East. Actimel was released as DanActive in the United States on a limited regional basis in 2004 (flavours Strawberry, Vanilla, and Blueberry) then was given a nationwide launch in 2007 (adding the flavour Cranberry/Raspberry).

Ingredients

Standard Actimel (excludes variations such as Actimel Light) contains:

  • Milk (fresh/powder)
  • Sugar (sucrose)
  • Live Lactobacillus casei DN-114001 probiotic strain, 10 000 million per 100 mL bottle[1]
  • Live yoghurt cultures
  • Yummy Powder
  • Super Powers

Scientific basis

The main claimed benefit on body's defences is supported by several scientific studies as reported by the manufacturer various websites[3], although the list of scientific papers appears to be not homogeneous depending on each country's website.[4][5][6]

Claimed benefits could range from diarrhea[7][8][9] and allergy (rhinitis[10]) reduction for young children, improvement of the immune function in adults[11]) and seniors[12][13] and reduction of duration of winter infections for elderly.[14]

Some clinical studies, unmentioned by the manufacturer website, suggest potential effects in hospitalized environment, like eradication of H. pylori along with antibiotics treatment for children[15] or restoration of activity of fecal enzymes in children after surgery.[16]

A recent study published by the British Medical Journal[17] suggests that the product could help to avoid antibiotic associated diarrhea and to limit Clostridium difficile infections in elderly patients, information that received some media coverage in the UK.[18] In 2008 some British hospitals decided to use the product as part of the patient’s diet to fight the dangerous spread of C. difficile superbug.[19]

More research is going on to determine the effectiveness, or otherwise, of this product in reducing the occurrence of more common illnesses in children attending daycare centers in the US. [20] This trial is listed by the US government website clinicaltrials.gov [21] where clinical trials have to be registered prior to their start, in a move to increase overall credibility when studies are financially sponsored by the drug (or food) manufacturer as in this case (proponents of a registry argue that the results of clinical trials with negative results are often not published by the sponsor of the study). The details recorded there state that this study was completed in June 2007 but according to its listing the findings have not yet been published.

Debates surrounding health claims on probiotic foods

See also Health claims on food labels.

On January 23 2008, a proposed class action was filed in California, accusing Danone Co. Inc. of false advertising in their marketing of yogurt containing probiotic bacteria (Danactive & Activia), alleging that the claimed health benefits have never been proven [22]. The company has denied this accusation. [23]

Foodwatch claims that Danone "makes a mountain out of a molehill" in suggesting that Actimel protects from cold and boosts health. Foodwatch believes that the company sells a common product using excessive advertising.[24]

The Advertising Standards Authority (ASA) is an independent regulator for advertisements, sales promotion and direct marketing in the UK. According to Spiegel Online one TV spot from Actimel was blocked by the ASA in 2006 and one in 2008. [25] In the first case the ASA upheld a complaint that the advert misleadingly implied that children given Actimel would be prevented from catching bacterial infections.[26] Meanwhile in the second case complaints about the use of the phrase "Actimel is scientifically proven and you can see that proof for yourself on our website" were upheld as only summaries of, or references to, these studies were present on the website and the full content was not available[27].

A TV advert which stated that Actimel was "scientifically-proven to help support your kids' defences" was banned by the Advertising Standards Authority.[28]

Alexa Meyer, from the Department of Nutritional Sciences, University of Vienna, Austria, comparing probiotic drinks and normal yoghurt, found no significant difference in the effect of Actimel and normal yogurt with living bacteria. The nutritional researcher recommends to get enough sleep, wash hands often and eat a daily bowl of yoghurt. She says this would activate more active germ-fighting white blood cells, enhancing the immune system, probably due to the presence of Lactobacillus bulgaricus, from any normal yogurt, which has half the price of Actimel.[29]

This is supported by Berthold Koletzko from the University of Munich, Metabolic Diseases and Nutrition, Munich, Germany in case of diarrhoea advises parents to give their children yogurt with living bacteria. It does not necessarily need to be Actimel, but may also be other yogurts. A measurable health benefit linked to the presence of live Streptococcus thermophilus and Lactobacillus delbrueckii sp. Bulgaricus was reported by Koletzko and colleagues 2005 yoghurt. In this review Koletzko and colleagues say that it was clearly demonstrated that yoghurt containing viable bacteria improves lactose digestion and eliminates symptoms of lactose intolerance, and clearly fulfil the current concept of probiotics. [30]

Within the 27 countries of the European Union, a new health claims regulation was put in place by the European Commission as of July 1 2007 [31], under which companies who wish to make claims about the nutritional & functional benefits of a product must support the claims with scientific evidence.[32]

In Canada, a similar regulation is currently in the works at Health Canada,[33] as it plans to update its assessment framework to make the system clearer and the claims more credible.[34]

Nutrition facts

Danone Actimel plain 0% actually contains 3.3 g of sugar, original plain contains 10.5 g of sugar, multifruit contains 12.0g of sugar for every serving (100g). None of those concentrations are higher than the level defined as “HIGH” by the UK Food Standards Agency (described for concentrations of sugar above 15g per 100g).[35] As a comparison Coca-Cola and orange juices are also in the range of 10g of sugar per 100g, but with a serving size usually higher than 250 ml the total sugar quantity is much higher.

Through Nutrient profiling guidelines, current health claim regulation in European Union may forbid the use of health claim on food products that are nutritionally unbalanced, but dairy products and probiotic drinks are likely to be considered as favorable carrier because their health benefits outweight the fact they might be high in one of the designated 'unhealthy' ingredients.[36]


References

  1. ^ a b DanActive: Help strengthen your body's defenses
  2. ^ [http://www.marketresearch.com/product/display.asp?productid=1493783&g=1 Danone Actimel: Innovation Builds a Probiotic Mega-Brand
  3. ^ How does Actimel help to boost your immune system | Scientific evidence | For Children
  4. ^ http://www.actimelusa.com/8044-Lactobacillus%20Casei%20Clin%20study_a.pdf
  5. ^ Actimel Ayuda a tus Defensas
  6. ^ Danone-et-Vous-Vos-Marques-Actimel
  7. ^ Pedone CA, Arnaud CC, Postaire ER, Bouley CF, Reinert P (2000). "Multicentric study of the effect of milk fermented by Lactobacillus casei on the incidence of diarrhoea". Int J Clin Pract. 54(9): 568–71. PMID 11220983. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  8. ^ Pedone CA, Bernabeu AO, Postaire ER, Bouley CF, Reinert P (1999). "The effect of supplementation with milk fermented by Lactobacillus casei (strain DN-114 001) on acute diarrhoea in children attending day care centres". Int J Clin Pract. 53(3): 568–71. PMID 10665128. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  9. ^ Agarwal KN, Bhasin SK (2002). "Feasibility studies to control acute diarrhoea in children by feeding fermented milk preparations Actimel and Indian Dahi". Eur J Clin Nutr. 56(4): 56–9. doi:10.1038/sj.ejcn.1601664. PMID 12556949. {{cite journal}}: Unknown parameter |month= ignored (help)
  10. ^ Giovannini M, Agostoni C, Riva E, Salvini F, Ruscitto A, Zuccotti GV, Radaelli G; Felicita Study Group (2007). "A randomized prospective double blind controlled trial on effects of long-term consumption of fermented milk containing Lactobacillus casei in pre-school children with allergic asthma and/or rhinitis". Pediatr Res. 62(2): 215–20. doi:10.1203/PDR.0b013e3180a76d94. PMID 17597643. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  11. ^ Marcos A, Wärnberg J, Nova E, Gómez S, Alvarez A, Alvarez R, Mateos JA, Cobo JM (2004). "The effect of milk fermented by yogurt cultures plus Lactobacillus casei DN-114001 on the immune response of subjects under academic examination stress". Eur J Nutr. 43(6): 381–9. doi:10.1007/s00394-004-0517-8. PMID 15309418. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  12. ^ Parra MD, Martínez de Morentin BE, Cobo JM, Mateos A, Martínez JA (2004). "Daily ingestion of fermented milk containing Lactobacillus casei DN114001 improves innate-defense capacity in healthy middle-aged people". J Physiol Biochem. 60(2): 85–91. PMID 15457926. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  13. ^ Parra MD, Martínez de Morentin BE, Cobo JM, Mateos A, Martínez JA (2004). "Monocyte function in healthy middle-aged people receiving fermented milk containing Lactobacillus casei". J Nutr Health Aging. 8(4): 208–11. PMID 15316583.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  14. ^ Turchet P, Laurenzano M, Auboiron S, Antoine JM (2003). "Effect of fermented milk containing the probiotic Lactobacillus casei DN-114001 on winter infections in free-living elderly subjects: a randomised, controlled pilot study". J Nutr Health Aging. 7(2): 75–7. PMID 12679825.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  15. ^ Sýkora J, Valecková K, Amlerová J, Siala K, Dedek P, Watkins S, Varvarovská J, Stozický F, Pazdiora P, Schwarz J (2005). "Effects of a specially designed fermented milk product containing probiotic Lactobacillus casei DN-114 001 and the eradication of H. pylori in children: a prospective randomized double-blind study". J Clin Gastroenterol. 39(8): 692–8. doi:10.1097/01.mcg.0000173855.77191.44. PMID 16082279. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  16. ^ Pawłowska J, Klewicka E, Czubkowski P, Motyl I, Jankowska I, Libudzisz Z, Teisseyre M, Gliwicz D, Cukrowska B (2007). "Effect of Lactobacillus casei DN-114001 application on the activity of fecal enzymes in children after liver transplantation". Transplant Proc. 39(10): 3219–21. doi:10.1016/j.transproceed.2007.03.101. PMID 18089357. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  17. ^ Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial - Hickson et al., 10.1136/bmj.39231.599815.55 - BMJ
  18. ^ Actimel drinks stop superbug | The Sun |HomePage|News
  19. ^ Doctors unveil latest weapon against hospital superbugs - drinking probiotic yoghurt | Mail Online
  20. ^ Decreasing Rates of Illness in Kids (DRINK) - Full Text View - ClinicalTrials.gov
  21. ^ Home - ClinicalTrials.gov
  22. ^ CTV.ca | Dannon sued over probiotic yogurt claims
  23. ^ Dannon Refutes Class Action Lawsuit Alleging Misleading Claims | Reuters
  24. ^ Foodwatch: Abgespeist: Actimel von Danone. Activer Etikettenschwindel. 17.12.2008. danone_actimel_compactinfo_20081217 http://www.abgespeist.de/actimel/index_ger.html
  25. ^ Amann, Susanne: Marketing-Erfolg. Mit Joghurt Millionen scheffeln. Spiegel Online 22.12.2008 http://www.spiegel.de/wirtschaft/0,1518,druck-597184,00.html
  26. ^ ASA adjudication 1st November 2006 http://www.asa.org.uk/asa/adjudications/Public/TF_ADJ_41911.htm
  27. ^ ASA adjudication 12th March 2008 http://www.asa.org.uk/asa/adjudications/Public/TF_ADJ_44120.htm
  28. ^ BBC 'Healthy' yoghurt advert banned 13 October 2009
  29. ^ Meyer AL, Micksche M, Herbacek I, Elmadfa I.: Daily intake of probiotic as well as conventional yogurt has a stimulating effect on cellular immunity in young healthy women. Ann Nutr Metab. 2006;50(3):282-9. Epub 2006 Feb 23. http://www.ncbi.nlm.nih.gov/pubmed/16508257
  30. ^ Guarner, F.; Perdigon, G.; Corthier, G.; Salminen, S.; Koletzko, B.; Morelli, L.: Should yoghurt cultures be considered probiotic? Br J Nutr. 2005 Jun;93(6):783-6. Review. http://www.ncbi.nlm.nih.gov/pubmed/16022746
  31. ^ EFSA releases first health claims guidelines
  32. ^ Health claims deadline passes
  33. ^ Managing Health Claims for Foods in Canada: Towards a Modernized Framework
  34. ^ Canada seeks opinion on health claims review
  35. ^ http://www.eatwell.gov.uk/healthydiet/nutritionessentials/fatssugarssalt/sugars
  36. ^ European nutrient profiling may exempt key food groups
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