Probiotics and Health Claims E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 817

Veröffentlichungsjahr: 2010

Beschreibung

This book examines the international picture regarding probiotic food applications, placing a particular emphasis on the legal context and assessment procedures of probiotic health claims in the major markets for these products. Health claim legislation is described and the ways in which manufacturers can ensure compliance are discussed. The book also covers the use of meta-analysis to assess available data, and case examples from various regulatory cultures and traditions are included. It will be of interest to food industry scientists, executives and R&D personnel; international regulatory advisers and administrators; researchers, educators and students on food science courses. Key Features: * Focuses on health claim legislation for this commercially important food sector * Includes chapters on the current situation in all the major world markets including Europe, the USA, Japan, India and China * Covers food, feed and pharmaceutical applications of probiotics

Leseprobe

Probiotics and Health Claims

This edition first published 2011 © 2011 Blackwell Publishing Ltd.

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Library of Congress Cataloging-in-Publication Data

Probiotics and health claims / edited by Wolfgang Kneifel, Seppo Salminen.p. cm.Includes bibliographical references and index.ISBN 978-1-4051-9491-4 (hardback : alk. paper) 1. Probiotics–Health aspects. 2. Probiotics–Law and legislation. I. Kneifel, Wolfgang. II. Salminen, Seppo.[DNLM: 1. Probiotics–therapeutic use. 2. Food Industry–legislation & jurisprudence. QU 145.5 P9214 2011]RM666.P835P78 2011615'.329—dc22

2010020489

A catalogue record for this book is available from the British Library.

This book is published in the following electronic formats: ePDF (9781444329391); Wiley Online Library (9781444329384); ePub (9781444329407)

Contents

Preface

Contributors

1 Probiotics and Health: From History to FutureBarry R. Goldin

1.1 Early history of the use of microorganisms for human benefit

1.2 Overview of probiotic studies and results for the past 35 years

1.3 Current evidence for probiotic health benefits

1.3.1 Lactose intolerance

1.3.2 Inflammatory bowel disease

1.3.3 Treatment of gastroenteritis

1.3.4 Cholesterol lowering

1.3.5 Treatment for urogenital infections

1.3.6 Treatment of allergic reactions

1.3.7 Prevention of dental caries

1.3.8 Treatment and prevention of cancer by probiotics

1.3.9 Additional health benefits attributed to probiotics

1.3.10 Conclusions based on past and present use of probioticsfor health applications

1.4 Nutritional effects of probiotics

1.5 Future development and uses of probiotics for health application

1.5.1 Probiotics as a platform for delivery of drugs, enzymes, hormones, nutrients and micronutrients

1.5.2 Toxin sequestration

1.5.3 Carcinogen detoxification

1.5.4 Antibody production

1.5.5 Treatment for enzyme deficiencies

1.5.6 Other potential future directions for probiotics for medical use

1.6 Conclusions

2 The World's Oldest Probiotic: Perspectives for Health Claims Tomoyuki Sako

2.1 From theory to practice: the challenge of Dr Minoru Shirota

2.1.1 The discovery of Lactobacillus casei strain Shirota

2.1.2 Early studies in Japan: the first clinical study era for Yakult and L. casei Shirota

2.1.3 Probiotic definition and the L. casei Shirota strain

2.2 Health benefits of Yakult and L. casei Shirota

2.2.1 Identification and characterisation of L. casei Shirota

2.2.2 Beneficial modulation of the intestinal microbiota

2.2.3 Improvement of stool consistency

2.2.4 Protection from infection

2.2.5 Immune modulation activity

2.2.6 Prophylactic effect of L. casei Shirota on cancer development

2.3 Safety

2.4 Health claims for L. casei Shirota and the product Yakult

2.5 Current perspectives

3 Probiotics: from Strain to ProductArthur C. Ouwehand, Lisbeth SØndberg Svendsen and Gregory Leyer

3.1 Introduction

3.2 Isolating a potential probiotic strain

3.3 Producing probiotic strains on a large scale

3.4 Producing products containing probiotics

3.4.1 Fermented milk products

3.4.2 Cheese

3.4.3 Non-fermented milk drinks

3.4.4 Fruit and vegetable juices

3.4.5 Dried products

3.5 Probiotic products and feeding trials

3.6 Conclusion

4 Probiotics and Health Claims: Challenges for Tailoring their EfficacyChristophe Chassard, Franck Grattepanche and Christophe Lacroix

4.1 Introduction

4.2 Current selection of probiotics: setting the scene for tailoring probiotics

4.2.1 Safety considerations

4.2.2 Technological considerations

4.2.3 Functionality and health benefits

4.3 Improving the assessment of probiosis

4.3.1 In vitro models for the assessment of probiosis

4.3.2 In vivo models for the assessment of probiosis

4.3.3 Clinical trials for the assessment of probiosis

4.4 Improving the discovery of probiotic strains

4.4.1 Exploring and isolating bacterial diversity

4.4.2 New generations of probiotics from new bacterial generaand with new targeted functions

4.5 Improving probiotic specificity

4.5.1 Future therapeutic strategies: combination of strains?

4.5.2 Nutritional manipulation

4.5.3 Genetic engineering

4.6 Conclusions

5 Probiotics: from Origin to Labeling from a Europeanand Brazilian PerspectiveCélia Lucia Ferreira, Marcos Magalhães, Miguel Gueimonde and Seppo Salminen

5.1 Introduction

5.2 Terminology and probiotics

5.3 Health claim regulation in the European Union

5.4 Health claims in Europe

5.5 Health claim regulation in Brazil

5.6 Defining health claims

5.6.1 Characterization of probiotic bacteria

5.6.2 Safety assessment

5.6.3 Human intervention studies for health claims

5.6.4 Totality of supporting evidence

5.7 Specific challenges for probiotics

5.7.1 Viability

5.7.2 Clinical studies demonstrating efficacy of probiotics in healthy subjects

5.7.3 Challenges in regulatory areas

6 Substantiating Health Benefit Claims for Probiotics in the United StatesMary Ellen Sanders

6.1 Introduction

6.1.1 Probiotics and health benefits

6.1.2 Probiotics: a term often misused

6.2 Health benefit claims allowable in the United States

6.2.1 FDA and FTC standards

6.2.2 Structure/function claims

6.2.3 Health claims

6.2.4 Medical food claims

6.3 Substantiation of health benefit claims for probiotics

6.3.1 Overriding considerations

6.3.2 Specific issues related to human efficacy studies

6.3.3 Key considerations for probiotic efficacy substantiation

6.4 Bridging the gap between the US consumer, probiotic science and commercial products

6.5 Conclusions

7 Health Claims and Dietary Guidance in the United States: Case “Reduced Cardiovascular Disease Risk”Alice H. Lichtenstein

7.1 Introduction

7.2 Types of health claims

7.2.1 Definition

7.2.2 Authorized health claims

7.2.3 Qualified health claims

7.2.4 Structure/function claims

7.2.5 Nutrient content claims

7.3 Legislation governing US health claims

7.3.1 Nutrition Labeling and Education Act (NLEA 1990)

7.3.2 Food and Drug Administration Modernization Act(FDAMA 1997)

7.3.3 Consumer Health Information for BetterNutrition Initiative (2003)

7.4 Dietary guidance to reduce cardiovascular disease risk

7.4.1 Dietary Guidelines for Americans

7.4.2 National Cholesterol Education Program

7.4.3 Dietary Reference Intakes

7.4.4 American Heart Association

7.4.5 American Diabetes Association

7.4.6 American Cancer Society

7.4.7 Case study: evolution of Dietary Guidelines for Americans

7.5 Current challenges

8 Probiotics and Health Claims: a Japanese PerspectiveFang He and Yoshimi Benno

8.1 Introduction

8.2 FOSHU health claims

8.2.1 History of FOSHU

8.2.2 Specifics of FOSHU health claims

8.2.3 Procedure for obtainining permission for FOSHU

8.2.4 FOSHU health claim for probiotics: gastrointestinal conditions

8.3 Non-FOSHU health claims for probiotics in Japan

9 Regulation of Probiotics in ChinaAnu Lahteenmäki-Uutela

9.1 Introduction

9.2 Health food or medicine?

9.3 Health food regulations

9.4 Novel food regulation

10 Probiotics and Health Claims: an Indian PerspectiveJashbhai B. Prajapati and Nagendra P. Shah

10.1 The background

10.2 The status

10.3 Animal studies

10.3.1 Chicken

10.3.2 Albino rats

10.3.3 Pigs

10.3.4 Sheep

10.3.5 Calves

10.3.6 Fish

10.3.7 Post-larvae

10.4 Human studies

10.4.1 Probiotics in gut microbiology

10.4.2 Probiotics in diarrheal diseases

10.4.3 Effects on lipid profile

10.4.4 Morbidity and nutritional status

10.5 An Indian perspective on regulation of probiotics

11 The Role of Meta-analysis in the Evaluation of Clinical Trials on ProbioticsHania Szajewska

11.1 Introduction

11.2 What is a systematic review? What is a meta-analysis?

11.3 How to conduct a systematic review

11.3.1 Formulation of the review question (the problem)

11.3.2 Searching

11.3.3 Selecting studies and collecting data

11.3.4 Assessment of methodological quality (i.e. the risk of bias in included trials)

11.3.5 Analysing the data and presenting the results

11.4 Why perform a meta-analysis?

11.5 Heterogeneity

11.6 How to interpret a forest plot

11.7 Critical appraisal of a systematic review

11.8 Published meta-analyses on the effects of probiotics

11.8.1 Acute gastroenteritis

11.8.2 Antibiotic-associated diarrhea

11.8.3 Clostridium difficile-associated diarrhea

11.8.4 Traveler’s diarrhea

11.8.5 Necrotizing enterocolitis

11.8.6 Helicobacter pylori infection

11.8.7 Functional gastrointestinal disorders

11.8.8 Irritable bowel syndrome

11.8.9 Inflammatory bowel disease

11.8.10 Functional constipation

11.8.11 Allergy prevention

11.8.12 Respiratory tract infections

11.9 Is a meta-analytical approach appropriate for assessing the efficacy of probiotics?

11.9.1 Arguments for pooling data

11.9.2 Arguments against pooling data

11.10 What could be the solution?

11.11 Unpublished data

11.12 Quality of included trials

11.13 Inconclusive systematic reviews and meta-analyses

11.14 Opposite conclusions

11.15 Summary and key messages

12 Applied Studies with Probiotics: Fundamentals for Meeting the Health ClaimsHannu Mykkänen, Silvia W. Gratz and Hani El-Nezami

12.1 Introduction

12.2 Mycotoxin problem

12.3 Lactobacillus rhamnosus strain effectively binds aflatoxin: in vitro findings

12.4 Animal models for studying the aflatoxin–probiotic interaction

12.5 Field studies with Lactobacillus rhamnosus strain in aflatoxin-exposed populations

13 Probiotics Research: the Pediatric PerspectiveKarl Zwiauer

13.1 Introduction

13.2 Development of the gastrointestinal flora postnatally

13.3 Probiotics in infant nutrition

13.3.1 Growth of healthy infants

13.3.2 Probiotics in preterm infants

13.3.3 Safety concerns

13.4 Clinical effect of probiotics in children

13.4.1 Prevention of allergic disease: food hypersensitivity

13.4.2 Atopic dermatitis

13.4.3 Prevention of antibiotic-associated diarrhea

13.4.4 Acute gastroenteritis and community-acquired diarrhea

13.4.5 Irritable bowel syndrome and constipation

13.4.6 Infantile colic

13.4.7 Inflammatory bowel disease

13.4.8 Oral health effects: caries

13.4.9 Other clinical conditions

13.5 Summary and key messages

14 Probiotics and Health Claims Related to OTC Products and Pharmaceutical PreparationsFrank M. Unger and Helmut Viernstein

14.1 Introduction

14.2 Production, processing and formulation of probiotic culturesfor pharmaceutical purposes

14.3 Clinical studies

14.3.1 Gastroenterology

14.3.2 Gynecology

14.3.3 Dentistry/stomatology

14.4 Evaluation and outlook

14.4.1 Antibiotic-associated diarrhea and Clostridium difficile disease

14.4.2 Traveler's diarrhea

14.4.3 Helicobacter pylori infection

14.4.4 Lactose intolerance

14.4.5 Irritable bowel syndrome

14.4.6 Ulcerative colitis

14.4.7 Pouchitis

14.4.8 Crohn's disease

14.4.9 Bacterial vaginosis

14.4.10 Gingivitis, reduction of plaque and alleviationof gum bleeding

14.4.11 Selected experimental approaches to probiotic productswith new properties and in new indications

15 Probiotics and Health Claims: the Perspective of the Feed IndustryAnja Meieregger, Elisabeth Mayrhuber and Hans Peter Lettner

15.1 Introduction and history

15.2 Feed probiotics versus food probiotics

15.2.1 Gram-positive non-sporulating bacteria

15.2.2 Bacillus species

15.2.3 Yeasts

15.2.4 Filamentous fungi

15.3 Efficacy

15.4 Feed probiotics

15.4.1 Fundamentals

15.4.2 Industrial production

15.5 Authorisation processes

15.6 Probiotics as performance enhancers: conclusions

16 Developing LGG® Extra, a Probiotic Multispecies CombinationMaija Saxelin, Eveliina Myllyluoma and Riitta Korpela

16.1 Introduction

16.2 Strain selection

16.3 Probiotic characteristics of the strains

16.3.1 Gastrointestinal persistence and colonisation

16.3.2 Influence on human intestinal microbiota

16.3.3 Immunological effects in vitro

16.3.4 Potential for reducing dietary toxins

16.3.5 Safety aspects

16.4 Clinical studies on the probiotic multispecies LGG®Extra combination

16.4.1 Relieving symptoms of irritable bowel syndrome

16.4.2 Eradication of Helicobacter pylori and Candida

16.4.3 Other research areas

16.5 Conclusions

17 Probiotics and Health Claims: How to Be Met by SMEs?Miguel Gueimonde and Sampo J. Lahtinen

17.1 Introduction

17.2 Developing proprietary probiotic strains

17.3 Probiotic research by SMEs using strains from larger companies

17.4 Example of successful probiotic research program by an SME company: the development of probiotic strains Bifidobacterium longum 46 and B. longum 2C

18 Probiotic Products: How Can They Meet the Requirements?Wolfgang Kneifel

18.1 Introduction

18.2 Quality criteria of probiotics

18.2.1 Basic composition and nutrient profile

18.2.2 Nature, identity and safety of probiotic strains

18.2.3 Viability and probiotic viable count

18.3 Future perspectives

19 Probiotics and Health Claims: Hurdles for New Applications?Lorenzo Morelli

19.1 Introduction

19.2 Identifying the hurdles

19.2.1 Characterisation

19.2.2 Relationship to health

19.2.3 Scientific substantiation

19.3 Approaching the hurdles

19.3.1 Hurdle characterisation

19.3.2 Relationship to health

19.3.3 Scientific substantiation

19.4 New perspectives

19.4.1 General considerations

19.4.2 Functional genomics

19.5 Conclusions

20 Probiotics and InnovationJean-Michel Antoine, Jean-Michel Faurie, Raish Oozeer, Johan van Hylckama Vlieg, Jan Knol, Herwig Bachmann and Joël Doré

20.1 Introduction

20.1.1 Early history

20.1.2 Recent history

20.2 Not all probiotics are the same: genomic perspective

20.3 Not all probiotic foods are the same: functional perspective

20.4 Not all probiotics are cross-talking in the same way: dialogue with the host

20.4.1 Dialogue with the human intestinal microbiota:a logical trigger for innovation

20.4.2 Novel functional targets for the human intestinal microbiota

20.5 European regulatory perspective: a threat or an opportunity?

20.5.1 European regulatory perspective: a threat?

20.5.2 For innovation in probiotics, the present regulatory requirements are an opportunity

20.6 Conclusion

Index

Preface

Probiotics have a long history in nutrition and medicine, but their health benefits have been demonstrated only more recently, when proven standards of clinical assessment have been applied. These findings have contributed to the scientific basis for the establishment of health claims associated with some products. Concomitantly, the need for objective regulation of these claims has arisen. Today, health claim regulations are subject to intensive discussions in the public as well as by experts, and new legislative developments have been implemented in the European Union, the United States, Australia and New Zealand, China and Japan. Moreover, the Codex Alimentarius organization is still working on guidelines for global health claim definitions and assessment. Probiotic microorganisms as well as probiotic products can be regarded as the most prominent pacemakers in the area of functional foods and have always been important components providing demonstrated health benefits for various parts of the population. This development has enormously stimulated targeted research in the area of food and feed as well as in medical and pharmaceutical science.

Historical developments, from classical food fermentation to today’s highly defined areas of functional foods and even clinical foods, have had a major impact on nutritional and adjuvant therapy in many gastrointestinal-associated diseases and their risk reduction. Moreover, in addition to preventive measures, new fields of probiotic applications have gradually emerged worldwide during the last few years. Thus, it is important to illuminate and to evaluate the differences in health claim requirements and assessment procedures in major global market areas by the help of experts in various but cooperating disciplines.

The information collected in this book covers different scientific areas and viewpoints and will furnish food developers and scientists involved in the work on food, health and nutrition with current multidisciplinary expertise in this field. It is also intended to be used by researchers, consulting experts and regulators who need to compare the systems and guidance used in different parts of the world. The readership may also include nutrition professionals, physicians and teachers. Additionally, the contents have been designed to be valuable not only for food science but also for students in human and animal nutrition and microbiology as well as those studying pharmaceutical sciences and drug development. The chapters are written by renowned experts and will comprise a compendium on most up-to-date developments and associated requirements as well as assessment procedures. This enables the reader to develop probiotics and new probiotic research programmes for characterizing new strains, verifying health claims and understanding the food and health relationships with specific focus on probiotics.

Wolfgang Kneifel and Seppo SalminenVienna and Turku

Contributors

Jean-Michel Antoine

Danone Research

RD 128

Palaiseau Cedex, France

Herwig Bachmann

Vrije Universiteit Amsterdam

Systems Bioinformatics IBIVU

Amsterdam, The Netherlands

Yoshimi Benno

Benno Laboratory, Riken, WakoSaitama, Japan

Christophe Chassard

ETH Zurich

Laboratory of Food Biotechnology

Institute of Food, Nutrition and Health

Zürich, Switzerland

Joël Doré

INRA

Domaine de Vilvert

Jouy en Josas, France

Hani El-Nezami

School of Biological Sciences

University of Hong Kong

Pokfulam, Hong Kong, China

Jean-Michel Faurie

Danone Research

RD 128

Palaiseau Cedex, France

Célia Lucia Ferreira

Federal University of Viçosa,

Viçosa, Minas Gerais, Brazil

Barry R. Goldin

Department of Public Health and Community Medicine

Tufts University School of Medicine

Boston, Massachussetts, USA

Franck Grattepanche

ETH Zurich

Laboratory of Food Biotechnology

Institute of Food, Nutrition and Health

Zürich, Switzerland

Silvia W. Gratz

Rowett Institute of Nutrition and Health

University of Aberdeen

Aberdeen, UK

Miguel Gueimonde

Instituto de Productos Lécteos de Asturias

Consejo Superior de Investigaciones Científicas

Villaviciosa

Asturias, Spain

Fang He

Technical Research Laboratory

Takanashi Milk Products Co., Ltd

Yokohama, Kanagawa, Japan

Wolfgang Kneifel

Department of Food Science and Technology

Boku – University of Natural Resources and Life Sciences Vienna

Vienna, Austria

Jan Knol

Danone Research

Wageningen, The Netherlands

Riitta Korpela

University of Helsinki Institute of Biomedicine, Pharmacology, University of Helsinki, Finland

Christophe Lacroix

ETH Zurich

Laboratory of food Biotechnology Institute of Food, Nutrition and HealthZürich, Switzerland

Anu Lahteenmäki-Uutela

Turku School of Economics

Turku, Finland

Sampo J. Lahtinen

Danisco Oyj

Kantvik, Finland

Hans Peter Lettner

Lactosan GmbH & Co. KG

Kapfenberg, Austria

Gregory Leyer

Danisco USA

Madison, Wisconsin, USA

Alice H. Lichtenstein

Friedman School, Tufts University

Boston, Massachussetts, USA

Marcos Magalhães

Federal University of Viçosa,

Viçosa, Minas Gerais, Brazil

Elisabeth Mayrhuber

Lactosan GmbH & Co. KG

Kapfenberg, Austria

Anja Meieregger

Lactosan GmbH & Co. KG

Kapfenberg, Austria

Lorenzo Morelli

Istituto di Microbiologia Università Cattolica del Sacro Cuore

Piacenza, Italy

Hannu Mykkänen

School of Public Health and Clinical Nutrition

Department of Clinical Nutrition/ETTK

University of Kuopio

Kuopio, Finland

Eveliina Myllyluoma

Valio Ltd, Research and Development

Helsinki, Finland

Also: University of Helsinki, Institute of Biomedicine, Pharmacology University of Helsinki, Finland

Raish Oozeer

Danone Research

RD 128

Palaiseau Cedex, France

Arthur C. Ouwehand

Health & Nutrition Danisco Sweeteners

Kantvik, Finland

Jashbhai B. Prajapati

Department of Dairy Microbiology

SMC College of Dairy Science

Anand Agricultural University

Anand, Gujarat, India

Tomoyuki Sako

Yakult Europe BV

Almere, The Netherlands

Seppo Salminen

Functional Foods Forum

University of Turku

Turku, Finland

Mary Ellen Sanders

Dairy & Food Culture Technologies

Centennial, Colorado, USA

Maija Saxelin

Valio Ltd, Research and Development

Helsinki, Finland

Present address: Kiesikuja, Vantaa, Finland

Nagendra P. Shah

Faculty of Health Engineering and Science

Victoria University, Werribee Campus

Melbourne, Victoria, Australia

Lisbeth Søndberg Svendsen

Danisco A/S

Brabrand, Denmark

Hania Szajewska

Department of Paediatrics

The Medical University of Warsaw

Warsaw, Poland

Frank M. Unger

Department of Pharmaceutical Technology & Biopharmaceutics

University of Vienna

Vienna, Austria

Johan van Hylckama Vlieg

Danone Research

RD 128

Palaiseau Cedex, France

Helmut Viernstein

Department of Pharmaceutical Technology & Biopharmaceutics

University of Vienna

Vienna, Austria

Karl Zwiauer

Department of Paediatrics

Landesklinikum St Pölten

St Pölten, Austria