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Library of Congress Cataloging-in-Publication Data

Names: Shetty, Kalidas, editor.

Title: Functional foods and biotechnology : sources of functional foods and
ingredients / Kalidas Shetty, Dipayan Sarkar.
Description: Boca Raton : Taylor & Francis, 2020. | Series: Food
biotechnology series | Includes bibliographical references and index.
Identifiers: LCCN 2019047880 (print) | LCCN 2019047881 (ebook) | ISBN
9780367435226 (hardback) | ISBN 9781003003830 (ebook)
Subjects: LCSH: Functional foods. | Food--Biotechnology.
Classification: LCC TP248.65.F66 F846 2020 (print) | LCC TP248.65.F66
(ebook) | DDC 664/.024--dc23
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 Contents

PREFACE VII
EDITORS IX
CONTRIBUTORS XI

1 Introduction: Metabolic-Driven Ecological Rationale to Advance Biotechnological

Approaches for Functional Foods 1
KALIDAS SHETTY AND DIPAYAN SARKAR

2 Science Behind the Substantiation of Health Claims in Functional Foods: Current

Regulations 5
MARIANE LUTZ

SECTION 1 SOURCES OF FUNCTIONAL FOODS AND INGREDIENTS

3 Bioactive Ingredients from Corn and Lactic Acid Bacterial Biotransformation 19

LENA GÁLVEZ RANILLA

4 Human Health-Relevant Bioactive Functionalities of Ancient Emmer Wheat 47

ASHISH CHRISTOPHER, DIPAYAN SARKAR, AND KALIDAS SHETTY

5 Functional Bioactives from Barley for Human Health Benefits 61

RAMNARAIN RAMAKRISHNA, DIPAYAN SARKAR, AND KALIDAS SHETTY

6 Health Beneficial Functions of Black Soybean Polyphenols 87

YOKO YAMASHITA, YASUKIYO YOSHIOKA, HITOSHI ASHIDA

7 Bioprocessing Strategies to Enhance L-DOPA and Phenolic Bioactives in the Fava

Bean (Vicia Faba) 99
KALIDAS SHETTY, REENA RANDHIR, AND DIPAYAN SARKAR

v
C o n t e n t s

8 Human Health-Relevant Bioactives and Associated Functionalities of Herbs in the

Lamiaceae Family 115
LOKESH K MISHRA, DIPAYAN SARKAR, AND KALIDAS SHETTY

9 Lemnaceae: Source Food Supplements to Functional Foods 133

DR. VINAY RALE, DR. POOJA SINGH, DR. KALIDAS SHETTY

10 Xylooligosaccharides: Production and Use as Functional Foods 143

CHANDRARAJ KRISHNAN, SHIVUDU G, AND PRASANA MANIKANDA KARTIK J

11 Biotechnology of Non-Nutritive Sweeteners 165

REENA RANDHIR AND KALIDAS SHETTY

12 Carotenoprotein from Shrimp Process Waste 185

DR. RUPSANKAR CHAKRABARTI

INDEX 203

vi
 Preface

Ecological driven system-based solutions to advancing are integral parts of basic human existence and resilience
climate-resilient and health-focused food diversity are and therefore contribute significantly to the global carbon
essential to address rapidly emerging climate change- footprint that is the cause of the climate change burden.
linked food and nutritional insecurity and closely asso- This then requires strategies to make the food supply
ciated global public health challenges. Currently, in a chain and the underlying food system more environmen-
global population that is close to 7.5 billion, around 1 tally sustainable and health-focused based on ecologically
billion people are still facing severe hunger and under- driven systems-based solutions.
nourishment-linked health challenges, while imbalanced Such a health-focused food system based on food
and excess calorie-linked non-communicable chronic dis- diversity is therefore critical to counter both undernour-
eases (NCDs) are becoming the greatest public health ishment and excess calorie-linked chronic disease chal-
burden globally to over 1.5 billion people, and this level lenges that coexist in several communities across the
is steadily increasing. Further, malnutrition (both under- world. In the context of sustainable and health-focused
nourishment and excess of calories)-linked public health solutions, functional foods, which are defined as “foods
issues are increasing with the rapid emergence of climate that have a potentially positive effect on health beyond
change, which is placing an excessive burden not just basic nutrition,” can be advanced as value-added food
on food production but more so on the nutritional quali- system innovations that protect human health, especially
ties of foods, leading to serious public health challenges. against undernutrition and excess calorie-linked chronic
Therefore, building food diversity based on versatile and diseases. Overall, several foods, such as whole foods, for-
ecologically driven climate-resilient, health-focused, tified, bioprocessed, and bio-enriched foods, can be con-
nutritionally balanced, well-preserved, and culturally sidered as functional foods if they provide one or more
acceptable plant- and animal-based foods is important health-promoting functions when consumed as part of a
for overall sustainable solutions to this climate change- diet. Protection against chronic oxidative stress impact-
linked food and nutritional insecurity and related NCD ing cellular systems, countering macro- and microvascu-
challenges. These challenges are interconnected and lar complications, improving the human gut microbiome
extremely complex, and need ecologically focused sys- and associated health benefits, and improvement of cog-
tems-based solutions. The detrimental impacts of these nitive health are some of the health-promoting functions
emerging global challenges are not only restricted to the that can be harnessed through functional food system
health and well-being of contemporary societies but also innovations. As communities and individuals around the
add a burden to several emerging economic, social, and world are becoming more health conscious and making
political challenges for the world. Therefore, building dietary choices based on the quality of the nutritional pro-
and advancing sustainable solution-driven strategies and file and associated health benefits of foods, it is important
related policy measures to address these complex chal- to support them with necessary knowledge on diverse
lenges is a high priority and need special attention from sources of functional foods along with recent advances
both the public and private sectors of developed, devel- in innovations on biotransformation and host response-
oping, and underdeveloped countries across the world. linked analytical approaches of understanding the value-
This is because food production, processing, and quality added health benefits of functional foods for improving

vii
P r e f a c e

overall health, including community health. Based on define functional foods and their health claims are quite
these essential needs for building better understanding open-ended, this book also includes a chapter on the
on ecological-driven biochemical and metabolic rationale rationale of the regulatory legislation and critical insights
of functional foods and their associated health protective on evidence-based scientific approval processes to better
properties, the aim of Functional Foods and Biotechnology, understand the actual health benefits of functional foods
which kicks off the new “Food Biotechnology” series, and ingredients. Further, ten additional chapters of this
is to present recent scientific advances and research book present examples of novel sources of functional
innovations on metabolically aligned biotechnological foods and value-added ingredients such as corn based
approaches for functional food design and their potential on wider corn diversity, ancient emmer wheat, barley,
application for health-targeted value addition to address black soybean, fava bean, herbs from the Lamiaceae
food and nutritional insecurity-linked chronic disease and Lemnaceae families, xylooligosaccharides, non-
challenges. nutritive sweeteners, and carotenoprotein from seafood
This first book in the “Food Biotechnology” series, waste. These examples of sources of functional foods and
Sources of Functional Foods and Ingredients, specifically ingredients provide perspectives on their value-added
provides some examples of common and novel func- integration into wider food systems, driving towards
tional food and ingredient sources and the ecological the metabolic rationale to harness their potential health
and metabolic rationale for their integration in health- benefits to address both undernourishment and excess
focused food system innovations. The introduction of this calorie-linked chronic disease challenges. This book also
book provides an overall perspective on the “Metabolic- lays out the scientific foundation for the second book in
Driven Ecological Rationale to Advance Biotechnological the series on novel biotransformation approaches and
Approaches for Functional Foods” to build the conceptual recent advances in host response-based analytical tools
framework and scientific rationale for the two volumes to design functional foods and associated bioactive rich
of the book series. Since regulations and guidelines to functional ingredients.

viii
 Editors

Dr Kalidas Shetty is the Founding Director of the Global health-targeted food systems coupled with food diversity
Institute of Food Security and International Agriculture are more resilient to climate change. The rationale of this
(GIFSIA), Associate Vice President for International platform has relevance for managing malnutrition chal-
Partnership and Collaborations and Professor of Plant lenges from maternal to children’s health needs globally
Sciences at North Dakota State University (NDSU, Fargo, and to advance solutions for diet- and lifestyle-linked NCD
ND). Prior to joining NDSU, Dr Shetty was Professor challenges, including the role of indigenous foods and fer-
of Food Science at University of Massachusetts over 19 mented foods.
years. He earned a PhD in microbiology and an MS in
bacteriology from University of Idaho and was a post- Dr Dipayan Sarkar is a Research Associate at the
doctoral scientist at the University of Guelph, and at the Department of Plant Sciences, North Dakota State
National Institute of Agrobiological Sciences in Japan. Dr University (NDSU, Fargo, ND). He works closely with
Shetty was an inaugural Jefferson Fellow at the US State local and global research, education, and outreach ini-
Department in 2004 and further served as a consultant tiatives of the Global Institute of Food Security and
for five years. He has authored or co-authored over 250 International Agriculture (GIFSIA) at North Dakota
publications, including over 210 peer-reviewed journal State University to advance food security and nutri-
publications and additional reviews, concept papers, pat- tionally linked public health solutions. He received a
ents, and book chapters. Dr Shetty’s publications have Bachelor in Agricultural Science (Hons.) and Master
been cited widely. He has traveled widely as an invited in Agronomy from India. Later he earned a PhD in
speaker and has built strong research and educational “Plant Stress Physiology” from the Department of
collaborations with international institutions to advance Plant, Soil, and Insect Sciences at the University of
climate change resilient food systems that can concur- Massachusetts. He also worked as a post-doctoral
rently combat global food insecurity-linked public health scientist at the Department of Food Sciences of the
challenges. University of Massachusetts (Amherst, MA) under the
His primary research interests focus on the critical tutelage of Dr Kalidas Shetty. Dr Sarkar is the author
role of the cellular and metabolic basis of oxygen biol- of over 50 publications including 42 peer-reviewed
ogy for advancing new innovations in life sciences and research papers and additional review, concept papers,
especially agricultural and food innovations that advance and book chapters.
global food security and health in a sustainable environ- His primary research interest is in redox-linked
ment. This focus has contributed to very innovative metabolic regulation and physiological adjustments of
advances in the areas of crops for health, post-harvest food plants relevant for improving climate stress resil-
biology, nutraceuticals, functional foods, and food antimi- ience to advance sustainable agricultural production
crobial strategies as critical innovations to advance food practices. With this primary research goal, the spe-
security, in addition to malnutrition and hunger chal- cific focus is on bioactive compounds of food plants,
lenges. In particular, he has developed an innovative dual- especially phenolic compounds and their dual function
function “crops for climate resilience and health” research benefits, to improve the abiotic stress resilience of food
platform to counter diet-linked chronic diseases, where plants and to concurrently enhance the human health

ix
E d i t o r s

benefits of plant-based foods. Further, his research pre- and post-harvest stages. The overall vision of his
also advances several sustainable strategies and inno- research is to advance sustainable solutions to address
vations to develop biological, microbial, and natural rapidly emerging global climate change-linked food
chemical tools for enhancing bioactive compounds and nutritional security and NCD-linked public health
and associated dual-function benefits in food plants at challenges.

x
 Contributors

Hitoshi Ashida Prasana Manikanda Kartik J.

Graduate School of Agricultural Science Department of Biotechnology
Kobe University Indian Institute of Technology Madras
Kobe, Hyogo, Japan Chennai, India

Rupsankar Chakrabarti Vinay Kumar Rale

Central Institute of Fisheries Technology Symbiosis School of Biological Sciences
Mumbai Research Centre Symbiosis International (Deemed) University
Navi Mumbai, India Lavale, Pune, India

Ramnarain Ramakrishna
Ashish Christopher
Department of Plant Sciences
Department of Plant Sciences
North Dakota State University
North Dakota State University
Fargo, North Dakota
Fargo, North Dakota
Reena Randhir
Shivudu G Springfield Technical Community College
Department of Biotechnology Springfield, Massachusetts
Indian Institute of Technology Madras
Chennai, India Lena Gálvez Ranilla
Universidad Catolica de Santa Maria
Chandraraj Krishnan Arequipa, Peru
Department of Biotechnology
Indian Institute of Technology Madras Pooja Singh
Chennai, India DST-Woman Scientist
Symbiosis School of Biological Sciences
Mariane Lutz Symbiosis International (Deemed University)
CIESAL & Escuela de Medicina Lavale, Pune, India
Facultad de Medicina
Universidad de Valparaíso Yoko Yamashita
Viña del Mar, Chile Graduate School of Agricultural Science
Kobe University
Lokesh K. Mishra Kobe, Hyogo, Japan
Department of Basic Science, College of Community
Yasukiyo Yoshioka
Science
Graduate School of Science, Technology and Innovation
Central Agricultural University
Kobe University
Tura, India
Kobe, Hyogo, Japan

xi
Chapter 1

Introduction: Metabolic-Driven
Ecological Rationale to Advance
Biotechnological Approaches
for Functional Foods
Kalidas Shetty and Dipayan Sarkar

Improved global food systems for advancing food security non-plant food matrixes to provide functional components
and human health must also address the challenges to sus- with potential health benefits.
tainable solutions to the most critical ecological problems Overall, Functional Foods and Biotechnology, which
we face from climate change and the essential need to lower kicks off the new “Food Biotechnology” series, is divided
the carbon footprint of food production. Global food security into two interrelated books. The first book, Functional
challenges now face the double burden of undernourish- Foods and Biotechnology: Sources of Functional Foods, is
ment and excess of calories (from hyper-processed macro- focused on sources of novel functional bioactives and func-
nutrients with a deficiency in micronutrients). In addition, tional food ingredients, and also includes a chapter on regu-
the burden of excess calories is leading to a rapid increase latory issues (Theme 1), while the second book, Functional
in non-communicable chronic diseases (NCD), such as Foods and Biotechnology: Biotransformation and Analysis of
type 2 diabetes and its complications, in every region of the Functional Foods and Ingredients, is focused on (i) explor-
world. Solutions to these challenges require that we har- ing how these functional compounds and bioactives in food
ness the benefits of more climate-resilient food diversity in systems can be modulated and bio-transformed by meta-
the overall food system and across all the diverse ecologies bolic, enzymatic, and cellular tools to enrich overall levels
of the world in order to improve the health-related quality of or to induce them to relevant levels by stress-induced regu-
food systems and their ability to counter NCDs (Sarkar and lation (Theme 2), and (ii) examples of analytical tools and
Shetty, 2014a, b; Shetty and McCue, 2003). In order to har- approaches for understanding host responses in the design
ness the health benefits of diverse foods for better health of functional foods and associated bioactive-rich functional
through functional foods, metabolic innovations grounded ingredients (Theme 3).
in sound ecological, metabolic, and cellular biochemistry The rationale and concepts presented in these first
using a systemic rationale must be the basis of value-added two interrelated books in the series are well-aligned
food innovations. In using a systemic rationale, the criti- to challenges at the global level, where there is a rapid
cal control points of overall metabolic control points both emergence of diet-linked chronic diseases that represent
at the food system end and at the level of host response a new reality of food security (Shetty, 2014). This recent
must be addressed (Shetty, 2014; Shetty and Wahlqvist, global increase in diet-linked NCDs is resulting in a heavy
2004). Functional Foods and Biotechnology comprises two burden on long-term health care management and over-
interrelated books, building on the foundations of an ear- all costs in aging societies as well as demographically
lier book, Food Biotechnology, published in 2006, but takes younger emerging countries, thus consuming higher lev-
a more ecologically driven metabolic approach in exploring els of national health care budgets (Shetty, 2014). Overall,
a wider diversity of foods beyond the basic macronutrients, the burden of NCDs involves series of progressive meta-
integrating a more diverse array of food crops and other bolic malfunctions that manifest themselves by enhancing

1
Fu n c ti o n al Fo o ds a n d B i o t e c h n o l o g y

oxidative stress (i.e., respiration-driven oxygen function burdening human health in terms of, for example, vascu-
breakdown associated with energy needs) at the organ lar hemoglobin function and global ecology (e.g., worsen-
and cellular levels. Functional food-based diets designed ing algal blooms and associated toxins) (Shetty, 2014).
for the management of respiration-driven oxidative stress Overall, the lack of food diversity from an unsus-
and optimum metabolic energy needs will be an impor- tainable ecology that is focused on restricted food crop
tant part of the overall solution for combating NCDs. choices and animal foods and excess fertilizer application,
Therefore, the most cost-effective strategy of metabolic coupled with high consumption of hyper-processed car-
innovations for NCDs is the improved design of food crops bohydrates and lipids without micronutrients and oxygen
and non-crop foods based on agroecological diversity stress protecting phytonutrients, is contributing to the
and enhanced redox-linked bioactive components (i.e., global increase in obesity-linked NCDs. Solutions to the
respiration-driven oxygen stress protecting compounds), above challenges require integrated, systems-based strat-
which can modulate and prevent oxidative stress and thus egies that use nutrition and functional food-based food
mitigate energy-optimized functional impacts on NCDs security for the betterment of human and animal health
(Shetty, 2014). Such food design must contain a balance and for an improved and sustainable agroecology that is
of both macronutrients and micronutrients as ingredi- based on crop and food diversity, and also on promoting
ents, including bioactive compounds that can counter the diverse ethnic food concepts that are built from all human
oxidation-linked malfunctions of NCDs. Such bioactive- experiences (Shetty, 2014; Shetty and Sarkar, 2018).
enriched foods are also essential to advancing commu- Integrated systems-based platforms are needed
nity-wide nutrition and health, while also increasing the to advance strategies and innovations across all areas
agroecological diversity (i.e., plant biodiversity) of local of life sciences. Such integration will extend into global
food crops. All of these efforts greatly benefit global ecol- food security challenges, where systems strategies will
ogy, where climate resilience will be the most important be used to assist in the development of biologically based
challenge to managing an improved health-driven founda- solutions in a post-genome era (Shetty, 2014; Sarkar and
tion of the overall food system that also can support the Shetty, 2014b). The calorie model of limited agricultural
economic systems of diverse communities in different commodities is incomplete and must be improved, as
ecologies that are facing the burdens of climate change increased calorie density from highly processed foods
(Shetty, 2014). does not account for the variability in respiration-driven
Based on the previously discussed rationale and oxygen function responsible for cellular energy genera-
understanding, the current global food and nutritional tion from foods. Food components must not only provide
security model must be improved to generate adequate basic macro-/micronutrients, but also counter oxygen
global food production from a wide diversity of crops in malfunction through compounds such as phenolic phy-
diverse ecologies that will meet macro-/micronutrient tochemicals (i.e., oxygen stress modulation) and diverse
needs along with phytonutrients (e.g., phenolic antioxi- sources of fibers that support the beneficial microbiome
dants as one example) to counter obesity-linked NCDs and that are removed during food processing.
(Shetty, 2014). The NCD epidemic represents a large From this systems-based foundation of redox-
financial burden on health care systems worldwide, a balancing foods, crop and animal metabolic innovations
burden that has been increasing in recent years in both based on an ecological rationale must emerge (Shetty and
developed aging societies and emerging young countries Wahlqvist, 2004; Shetty, 2014; Sarkar and Shetty, 2014b).
with rapidly growing economies. The current economic This approach has the potential benefits of addressing
and production practices favor highly processed carbo- both food processing and, in particular, primary agricul-
hydrate-enriched foods and are dependent on a narrow tural production challenges, and of improving their resil-
selection of major cereal crops such as rice and wheat, ience to climate change. These integrated systems must
with corn for animal foods (Shetty, 2014). These cereal be part of the overall solutions to more resilient and multi-
crops are less resilient and robust in responding to and purpose agricultural systems and to supporting ecologi-
dealing with climate change extremes because they are cally diverse ethnic foods that better address global food
bred for yields rather inducible responses to abiotic stress security through crop and food diversity models, both for
(e.g., salinity, drought, and temperature). In addition, a more resilient climate-adapting ecological sustainabil-
global food security currently is dependent on petroleum ity and for an improved approach to addressing the chal-
fossil fuel-based nitrogen, which contributes to the unsus- lenges facing human health (Shetty and Sarkar, 2018).
tainable addition of nitrogen wastes that affect ecology Crops and foods for health-targeted design and devel-
and human health, especially along water bodies that link opment and related food-processing technologies must
global river systems to oceans (Shetty, 2014). Globally, develop agricultural systems for climate change resilience
nitrogen in the soil has more than doubled in the last 100 and robustness, using both dual function bioactive food
years. Excess nitrogen is a third ecological dimension crops and animal models based on redox biology (i.e.,
tp the food cycle that further worsens increasing carbon respiration-driven oxygen stress balance in cells), in which
emissions and rapidly degrades water quality, further oxygen stress-protecting bioactives for health can also

2
 I n t r o d u c t i o n

provide crop production resilience in response to climate book deals with sources of functional foods and ingredi-
change, and bioactives that support a beneficial microbi- ents (Theme 1), while the second book has two themes,
ome that further enhances overall health and resilience. the biotransformation of functional food and ingredients
Using concepts founded in redox biology, microbi- (Theme 2) and the analysis of functional foods and ingre-
ome-supporting bioactives, and fermentation biology, we dients (Theme 3) (Figure 1.1). To advance the conceptual
can develop health-relevant phytochemicals in crop food ecological rationale of the two books, this second edition
systems at pre-harvest and post-harvest stages for a range of provides good examples of a way forward in how we can
chronic diseases, including obesity-related and environmen- use strong ecological rationale for metabolic-driven foun-
tal breakdown-linked diseases (Sarkar and Shetty, 2014a). dations to build effective biotechnology strategies for the
These redox-linked metabolic innovations and research development of functional foods and ingredients.
strategies will be recruited to add value to diverse global In this first book, this introductory chapter is fol-
crop food systems in order to enhance value-added benefits. lowed by a chapter on regulatory issues (Lutz) that outlines
Further value-added food diversity can be harnessed to the science behind and current regulation of the substan-
address major public health challenges within ethnic com- tiation of health claims in functional foods. Following that,
munities across the world (Shetty and Sarkar, 2018). ten chapters focus on bioactive ingredients for food supple-
Followng on from the background to the realities ments and functional foods arising from different plant
that challenge global food security-linked health with sources, including corn (Ranilla), ancient emmer wheat
the rapid emergence of climate change, the rationale (Christopher et al.), barley (Ramakrishna et al.), black soy-
for this introductory chapter is to provide the perspec- bean (Yamashita et al.), fava bean (Shetty et al.), and herbs
tive and focus of the first two books in this new series on in the Lamiaceae family (Mishra et al.) and the Lemnaceae
metabolic-driven ecological rationale to advance biotech- family (Rale et al.). Other common sources for-value added
nological approaches for functional foods. Based on the ingredients are then discussed, including xylooligosaccha-
emerging need to advance deeper ecological rationale rides (Krishnan et al.), non-nutritive sweeteners (Randhir
with foundations in metabolic approaches, Functional and Shetty), and finally carotenoprotein from seafood
Foods and Biotechnology has been divided into two inter- waste (Chakrabarti), providing perspectives on widening
related books emphasizing three thematic areas: The first the search for sources of functional foods and ingredients.

Figure 1.1 Schematic diagram of the three thematic areas covered by Functional Foods and Biotechnology: Sources
of Functional Food and Functional Foods and Biotechnology: Biotransformation and Analysis of Function Foods and
Ingredients: (1) sources of functional foods and ingredients, (2) biotransformation of functional foods and ingredients, and
(3) analysis of functional foods and ingredients.

3
Fu n c ti o n al Fo o ds a n d B i o t e c h n o l o g y

In the second book, Section 1 (Theme 2) details the of in vitro enzyme inhibition assay models relevant to early
biotransformation of functional foods and ingredients, stages of type 2 diabetes and its complications. The chap-
beginning with a chapter on the metabolic modulation ter by Panchal et al., “The Potential Roles and Implications
of abiotic stress response for improvement of functional of Microbiota on Maternal and Child Health,” provides
ingredients in food plants by Sarkar and Shetty, which overall insights on how microbiome-rich foods are impor-
provides a novel and innovative integration of metaboli- tant for maternal and child health. Another important
cally driven abiotic stress response modulation to opti- area of functional analysis for food applications is innova-
mize functional bioactives for functional foods. This has tions in antimicrobial solutions, an area that is explored
important relevance in building climate-resilient food sys- in the chapters “Genetic Characterization of Antimicrobial
tems that also address public health challenges such as Peptides” (Hu et al.), “Natural Antimicrobials from Plants
NCD and improved food safety. The chapters by Deo et for Food Applications” (Garcia et al.), and “Quorum
al., Dey and Ray, and Agustinah et al. provide excellent Sensing Inhibitors from Phytochemicals and Food
examples of using targeted beneficial bacteria such as Sources and Their Potential Applications in Food Quality”
lactic acid bacteria to improve functional foods and ingre- (Bai and Rai).
dients. Furthermore, the volume also captures examples
of how traditional fermentations from the Indian subcon-
tinent (Kavitake et al.), Africa (Banwo et al.), and the
References
Mediterranean region (Kotzekidou) have relevance in
applications for developing functional foods and ingredi-
Sarkar, D. and Shetty, K. (2014a). Metabolic mobiliza-
ents. Additionally this section includes novel perspectives
tion strategies to enhance the use of plant-based
and insights with the chapters “Tequila: Biotechnology dietary antioxidants for the management of Type 2
of Microbial Flavors” by Neira-Vielma and Aguirre- diabetes. In V. Preedy (Ed.), Aging: Oxidative Stress
Joya, “Technologies Used for Microbial Production of and Dietary Antioxidants, Chapter 27, pp. 289–296.
Food Ingredients” (Ercan-Oruc et al.), “Biotechnology Oxford, UK: Elsevier.
of Microbial Flavors” (Vong and Liu), “Phospholipase D Sarkar, D. and Shetty, K. (2014b). Metabolic stimulation
Inhibition by Hexanal and Its Applications in Enhancing of plant phenolics for food preservation and health.
Shelf Life and Quality of Fruits, Vegetables, and Flowers” Annual Review of Food Science and Technology 5:
(Padmanabhan and Paliyath), “Production and Recovery 395–413.
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et al.), “Enzymatic Bioprocessing of Tropical Seafood synthesis in plants for functional food application:
Wastes to Functional Foods” (Chakrabarti) and “Egg Integration of systems biology and biotechnological
Yolk Antibodies Farming for Passive Immunotherapy” approaches. Food Biotechnology 17: 67–97.
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innovative strategies for metabolically driven biotransfor- role of proline-linked pentose phosphate pathway
mation approaches to the development of functional food in phenolic phytochemical biosynthesis and mecha-
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driven processes have a long history of use and in many applications: A review. Asia Pacific Journal of Clinical
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rity challenges to advance human health and global
In Section 2 (Theme 3) of Functional Foods
environment based on diverse food ecology. Pages
and Biotechnology: Biotransformation and Analysis of
65–73. A policy position paper presented at the
Functional Foods and Ingredients, the chapter by Hepsiba Conference on Food Safety, Security and Defense: 22
et al. focuses on cell and cell based models to screen Focus on Food and the Environment, convened by
the health promoting properties of dietary components. the Institute on Science for Global Policy (ISGP), on
The chapters by Qin et al. and Murthy et al., “Biological October 5–8, 2014 at Cornell University, Ithaca, NY.
Functions and Health Benefits of Food Polyphenols” and (ISBN: 978-0-9861007-0-3)
“Plant Phytochemicals for Cancer Chemoprevention: Shetty, K. and Sarkar, D. (2018). Editorial: Advancing
Applications and Advantages,” respectively, focus on can- ethnic foods in diverse global ecologies through sys-
cer chemoprevention models. The chapter “Beneficial tems-based solutions is essential to global food secu-
Lactic Acid Bacteria (LAB) Based Biotransformation of rity and climate resilience-integrated human health
Plant and Dairy Substrates to Enhance Type 2 Diabetes benefits. Journal of Ethnic Foods 5: 1–3. doi:10.1016/j.
Relevant Health Benefits” (Sarkar et al.) shows examples jef.2018.02.003

4
Chapter 2

Science Behind the Substantiation

of Health Claims in Functional
Foods: Current Regulations
Mariane Lutz

2.1 Introduction 5
2.1.1 Terms and Definitions 5
2.1.2 Regulation of FF 6
2.2 Scientific Substantiation of Health Claims 7
2.2.1 Analysis 7
2.2.2 Preclinical Studies 8
2.2.2.1 Bioaccessibility 8
2.2.2.2 Absorption 8
2.2.2.3 In Vivo Assays 9
2.3 Clinical Studies 10
2.4 Weighing the Scientific Evidence 11
2.5 Conclusions 12
References 12

2.1 Introduction perspective but also for economic reasons, since FF affect
the development of innovative products in the food indus-
In the last couple of decades, there has been a pronounced try. Health claims are designed to provide useful informa-
increase in consumer interest in healthier food products. tion to the consumer concerning the health benefits of
This has been driven by a variety of factors, including foods or food constituents, and legislation is designed to
the growing awareness of the importance of an adequate protect the consumer from misleading and false informa-
food intake in maintaining health and the process of tion. Therefore, health claims should be approved after a
healthy aging, mainly by preventing chronic diseases careful scientific substantiation of the beneficial effects.
such as hypertension, diabetes, cardiovascular disease
(CVD), cancer, and neurodegeneration, among others,
since life expectancy has increased steadily. In this con- 2.1.1 Terms and Definitions
text, the beneficial effects of functional foods (FF) may
be communicated through health claims, although this In order to be able to use a claim that associates the intake
requires adequate regulatory frameworks in order to pro- of a food or food constituent with a positive effect on health,
tect consumers not only from the sanitary and food safety it is necessary to substantiate the effect and scientifically