Developing tools (and materials) to facilitate the determination of the scientific substantiation of the benefits of foods in relation to maintenance and improvement of health and wellness

Background

Specific components of the diet can bring benefits beyond those of basic nutrition. However, these beneficial effects need to be supported by scientific evidence before they can be communicated to consumers and others via health or nutrition claims and other relevant channels.

Objectives

The Functional Foods Task Force addresses issues related to functional benefits of foods and develops tools, such as criteria for the evaluation of markers, to define the scientific substantiation of benefits of foods for improvement and maintenance of health and wellness.

Impact

The task force has been invited to present the outcomes of the microbiome-related activities at several internationally recognised conferences, such as the International Scientific Conference on Probiotics and Prebiotics (IPC 2016) and the 18th World Congress of Food Science and Technology (IUFoST 2016).

Concepts developed by this task force were taken into consideration by the European Regulation on Health Claims implemented in 2006 (EC 1924/2006). The EU projects FUFOSE and PASSCLAIM, coordinated by ILSI Europe, reached a consensus on scientific definitions and concepts of functional foods in Europe and since then the Functional Foods Task Force has built on and further developed these.

Following the first evaluation of health claim dossiers by the European Food Safety Authority (EFSA), the task force reviewed and evaluated the quality of published results of human intervention studies. In 2011, the task force published guidelines for designing, conducting and reporting human intervention studies for the substantiation of health claims in the British Journal of Nutrition (R.W. Welch et al., 2011).

A key milestone of the Marker Validation Initiative, launched in 2011, was a workshop in June 2012, where key public-private stakeholders gathered to establish a preliminary list of consensus criteria for validation of markers (J. de Vries et al., 2013).

What’s New

  • New Expert Group on ‘Oral and Systemic Health Resilience’.
  • Two New Activity Proposals: ‘Microbiome Human Study Research Guidance’, submitted for review, and ‘Markers for Nutrition and Health’, under development.

For more detailed information, please contact Dr Bettina Schelkle at bschelkle@ilsieurope.be.

Task Force Members

Prof. Colette Shortt – Chair Johnson & Johnson EAME UK
Dr Oliver Hasselwander – Vice-Chair DuPont Nutrition and Health UK
Prof. Kieran Tuohy – Co-Chair Fondazione Edmund Mach IT
Dr Maj-Britt Andersen Pfizer Consumer Healthcare US
Dr Douwina Bosscher Cargill BE
Dr Michael Dodds Mars Chocolate US
Dr Volker Elste DSM CH
Ms Ulla Freitas Lonza UK
Dr Sue Gatenby PepsiCo International UK
Ms Arancha González Abbott Nutrition ES
Dr Laurent Le Bellego Danone FR
Dr Alexandra Meynier Mondelēz Europe FR
Dr Sophie Nutten Nestlé CH
Ms Diana Polacek Red Bull AT
Prof. Gerhard Rechkemmer* Max Rubner-Institute, Federal Research Institute of Nutrition & Food DE
Dr Manuela Sailer Südzucker Group DE
Dr Matthias Sass ADM DE
Dr Jessica Türk Yakult Europe DE
Dr Sheila Wiseman Unilever NL
Dr Bettina Schelkle ILSI Europe BE

*Scientific Advisor

Expert Groups

Oral and Systemic Health Resilience 

Objectives

Oral health is increasingly acknowledged as a major factor affecting quality of life. The impacts of poor oral hygiene go far beyond caries and hard tissue damage. Gingivitis, a disease involving gum inflammation, is almost universal and, in extreme cases, leads to periodontitis and bone (and subsequent tooth) loss. Mild periodontitis is common in adults, with severe periodontitis occurring in up to 20% of the population. In addition, there is increasing evidence of a link between oral and systemic health (e.g. type 2 diabetes, cardiovascular diseases). It is unclear, however, whether this link is causal or because of a common mechanism related to chronic inflammation. It is known that a major factor in maintaining oral health is the resilience of the ecology of the oral system. The oral microbiota has an effect on oral health and it has also been postulated to affect systemic health. The main objective is to study the oral microbiome as a key factor in the prevalence and progression of gingivitis and periodontitis and systemic health parameters.

Activity

As a first step, this activity will define and characterise oral health, its maintenance and resilience. A scoping review will identify knowledge gaps and main influences on oral health homeostasis as well as ascertaining the host factors that influence oral health. Secondly, the link between oral and systemic health will be assessed. The most relevant factors within each sub-group (i.e. microbiome, host oral cavity, systemic effects) will be evaluated.

Expected Output

This activity will provide new insights into the evidence relating to oral and systemic health and will allow oral-systemic interactions to be distinguished from gut-systemic interactions. This will help provide scientific evidence for subsequent clinical confirmation of health claims related to both oral and systemic health.

Identifying Preferred Approaches for Quantifying the Impact of Modifying Nutrient Intakes 

Objectives

There are widespread, well-established, population-based recommendations for modifying diets to reduce the risk of non-communicable diseases. This information allows the food industry to change and optimise the composition of foods in line with this purpose. The aim of this activity is to identify and illustrate practical models that could be used as standardised methods of estimating the quality of life and the health impacts resulting from changes in the nutritional composition of foods.

Activity

This expert group is reviewing methodologies currently used to estimate the impact of nutrition interventions on health and quality of life. Quantitative results expressing quality of life measures will be used to illustrate the implications of the identified approaches. Recommendations on how to apply selected models will be provided.

Expected Output

A better understanding, consensus and standardisation of models applied to quantify the health impact of changes in food composition on populations will lead to more consistency in the approaches commonly used to assess, monitor, report, compare and communicate these impacts.

Exploring the Role of the Major Gut Microbiota Clusters on Nutritional and Functional Benefits of Nutrients and Non-nutrients

In collaboration with the Prebiotics Task Force

Objectives

The gut microbiota is involved in the metabolism and bio-availability of a large number of nutrients and non-nutrients. Therefore, it is an important variable to take into account when considering the management of obesity, inflammation and the metabolic syndrome. The aim of this activity is to collect and review existing data on different gut microbiota clusters (a specific constellation of microorganisms) in relation to their metabolic effects on selected nutrients and non-nutrients.

Activity

This expert group is systematically reviewing the available data on the effect of the gut microbiota on a selection of dietary substrates (including nutrients and non-nutrients) and also reviewing methodologies used and knowledge of the microbial pathways.

Expected Output

The expert group divided the activity into two parts, addressing each one in a separate manuscript:

  • A first paper has systematically collected and reviewed existing data on the effects of gastrointestinal microbiota on the metabolism of nutrients and non-nutrients;
  • A second paper has reviewed what is known about the gut microbiota and the microbial pathways associated with the metabolism of nutrients and non-nutrients and also reviewed methodologies that can be applied to study gut microbial pathways of metabolism.
  • A stakeholder workshop organised in collaboration with the Obesity and Diabetes Task Force was held on 3-4 December 2015 in Brussels, Belgium, to refine the conclusions drawn in the draft manuscripts. The outcomes of this expert group were presented at the ILSI Global Annual Meeting (25 January 2016, St. Petersburg, US), the APC Microbiome Workshop (23 February 2016, Brussels, Belgium), IPC 2016 (21-23 June 2016, Budapest, Hungary) and IUFoST 2016 (21-25 August 2016, Dublin, Ireland). A follow-up New Activity Proposal on ‘Microbiome Human Study Research Guidance’ is currently under review.

Marker Validation Initiative: Developing Consensus on Criteria to Evaluate Markers in Nutrition Research

Objectives

One of the main reasons why EFSA rejects many health claim dossiers is the lack of supporting evidence based on validated markers to prove the claimed potential health effects.

The aim of this multidisciplinary activity is to identify:

  • Criteria for validation of markers in nutrition research;
  • Validated markers for use in different fields of nutrition research.

Past Activities 

A key milestone of this activity (steps 1 and 2, see figure) was a workshop organised in Lisbon, Portugal, in June 2012. Key public-private stakeholders gathered to establish a preliminary list of consensus criteria, available in the literature and in different fields of nutrition research (J. de Vries et al., 2013).

In order to be valid, markers should:

  • Follow analytical rules;
  • Be validated according to recognised methods;
  • Reflect an endpoint:
    o Significant association between marker and endpoint in a target population;
    o Marker changes consistently with a change in the endpoint.

To be usable in nutrition research, the marker must furthermore respond to a dietary intervention.

Current Activity – Step 3

The current activity is a translation phase between the results of the workshop and the development of a tool to guide nutrition scientists in assessing the validity and relevance of markers when designing nutrition studies. An expert group has refined and applied the consensus criteria in different areas of nutrition research. A manuscript has been submitted for publication in a peer-reviewed journal.

Expected Output

The aim is to provide more granularity to the different criteria. In addition, an evidence-based grading system will be introduced which should allow effective weighting of the relative importance of individual criteria, thanks to a semi-quantitative score. This system could provide information about the usefulness/validity of the current markers for a given experimental situation. The same set of information could be used as primary guidelines for the development of new markers. A follow-up New Activity Proposal on ‘Markers in Nutrition and Health’ is in the pipeline.

Expected Overall Output of the Initiative

The expected output of the Marker Validation Initiative is a set of validated markers in different fields of nutrition (e.g. mental performance, immunity).

Marker figure

Concise Monograph – Completed

Antioxidants and Anti-inflammatory Agents

Objectives

ILSI Europe published a Concise Monograph on ‘Oxidants, Antioxidants and Disease Prevention’ in 1995. Given the significant developments since then, the task force has updated this monograph from those previously published in 2002 and 2008 dealing with the topic in order to include the latest scientific conclusions. The monograph provides a concise overview of the state-of-the-art relating to free radicals, antioxidants and inflammation.

Activity

The monograph describes basic mechanisms and theories on how inflammation and oxidative stress may contribute to the genesis of diseases (e.g. cardiovascular, neurodegenerative), and the roles of anti-inflammatory and antioxidant agents. It investigates data from in vivo experiments (including human observation and intervention studies, biomarkers) and describes the mechanism of actions in foods and food ingredients.

Expected Output

This updated Concise Monograph entitled ‘Antioxidants and Anti-inflammatory Components of Foods’ is a reliable source of scientific information for the broader scientific community and policy makers that would like to refresh their knowledge on the subject.

Expert Group Members

Oral and Systemic Health Resilience – NEW

Prof. Bryan Hanley – Chair Knowledge Transfer Network UK
Prof. Wim Crieland – Vice-Chair University of Amsterdam NL
Dr Douwina Bosscher Cargill BE
Dr Michael Dodds Mars Chocolate US
Dr Nick Jakubovics University of Newcastle UK
Prof. Bruno Loos University of Amsterdam NL
Prof. Philip Marsh University of Leeds UK
Dr Manuela Sailer Südzucker Group DE
Dr Egija Zaura University of Amsterdam NL
Dr Bettina Schelkle ILSI Europe BE

Identifying Preferred Approaches for Quantifying the Impact of Modifying Nutrient Intakes – NEW

Prof. Gülden Pekcan – Chair Hasan Kalyoncu University TR
Dr Mariska Dötsch-Klerk – Vice-Chair Unilever NL
Ms Maaike Bruins DSM CH
Dr Patrick Detzel Nestlé CH
Prof. Janne Martikainen University of Eastern Finland FI
Dr Reyhan Nergiz-Unal University of Hacettepe TR
Dr Annet Roodenburg HAS University of Applied Sciences NL
Dr Bettina Schelkle ILSI Europe BE

Exploring the Role of the Major Gut Microbiota Clusters on Nutritional and Functional Benefits of Nutrients and Non-nutrients

Prof. Ian Rowland – Chair University of Reading UK
Prof. Glenn Gibson University of Reading UK
Dr Oliver Hasselwander DuPont Nutrition and Health UK
Prof. Karsten Kristiansen University of Copenhagen DK
Dr Alexandra Maynier Mondelēz Europe FR
Dr Arjen Nauta FrieslandCampina NL
Dr Karen Scott University of Aberdeen UK
Prof. Colette Shortt Johnson & Johnson EAME UK
Prof. Jonathan Swann Imperial College London UK
Dr Ines Thiele University of Luxembourg LU
Prof. Kieran Tuohy Fondazione Edmund Mach IT
Dr Jessica Türk Yakult Europe DE
Dr Joan Vermeiren Cargill BE
Dr Bettina Schelkle ILSI Europe BE
Dr Tobias Recker ILSI Europe BE

Marker Validation Initiative: Developing Consensus on Criteria to Evaluate Markers in Nutrition Research

Prof. Philip Calder – Chair University of Southhampton UK
Dr Jean-Michel Antoine* Danone FR
Prof. Alan Boobis Imperial College London UK
Dr Deborah Braun** Institut Mérieux (Biomérieux) FR
Ms Claire Champ University of Leeds UK
Prof. Louise Dye University of Leeds UK
Mr Arno Greyling Unilever NL
Dr Christophe Matthys University of Leuven BE
Prof. Jane Woodside Queen’s University Belfast UK
Dr Suzan Wopereis TNO NL
Dr Bettina Schelkle ILSI Europe BE

*Observer

Concise Monograph – Completed

Scientific Editor
Prof. Philip Calder University of Southampton UK
Author
Prof. Barry Halliwell National University of Singapore SG
Publication Committee Coordinator
Mr John Howlett Scientific Advisor UK
Task Force Representative
Dr Sheila Wiseman Unilever NL
Coordinator
Dr Peter Putz ILSI Europe BE

Poster

ILSI Europe Marker Initiative: What Makes a Marker a Valid Marker?

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