Substantiate Health Claims Research Articles

Probiotic Effector Compounds: Current Knowledge and Future Perspectives.

Understanding the mechanism behind probiotic action will enable a rational selection of probiotics, increase the chances of success in clinical studies and make it easy to substantiate health claims. However, most probiotic studies over the years have rather focused on the effects of probiotics in health and disease, whereas little is known about the specific molecules that trigger effects in hosts. This makes it difficult to describe the detailed mechanism by which a given probiotic functions. Probiotics communicate with their hosts through molecular signaling. Meanwhile, since the molecules produced by probiotics under in vitro conditions may differ from those produced in vivo, in vitro mechanistic studies would have to be conducted under conditions that mimic gastrointestinal conditions as much as possible. The ideal situation would, however, be to carry out well-designed clinical trials in humans (or the target animal) using adequate quantities of the suspected probiotic molecule(s) or adequate quantities of isogenic knock-out or knock-in probiotic mutants. In this review, we discuss our current knowledge about probiotic bacteria and yeast molecules that are involved in molecular signaling with the host. We also discuss the challenges and future perspectives in the search for probiotic effector molecules.

Should botanical health claims be substantiated with evidence on traditional use? Reviewing the stakeholders’ arguments

BackgroundThe evaluation of botanical health claims was put on hold to determine whether traditional use evidence is sufficient to substantiate these health claims. To gain a deeper understanding of the discussion on the substantiation of botanical health claims, a critical review of the stakeholders’ arguments was conducted. MethodsThe relationships of stakeholders were analysed with a social network analysis and the stakeholders’ arguments were critically reviewed with scientific literature. ResultsThe social network analysis showed that the majority of stakeholders were in favour of using traditional use evidence for botanical health claim substantiation. These stakeholders were however highly interrelated which may explain their similar viewpoints.The arguments put forward by the stakeholders cover a wide array of subjects indicating the discussion’s complexity. Various arguments could furthermore not be assessed with scientific literature as these were focused on the unpredictable impact of a decision on the substantiation of botanical health claims. The review also shows that stakeholders interpret various underlying concepts such as consumer misleading differently. ConclusionsThis study shows that the discussion is scattered. A political decision on various unclear concepts is required to eventually make a decision upon using traditional use evidence to substantiate botanical health claims.

Risks and benefits of consuming edible seaweeds.

Recent interest in seaweeds as a source of macronutrients, micronutrients, and bioactive components has highlighted prospective applications within the functional food and nutraceutical industries, with impetus toward the alleviation of risk factors associated with noncommunicable diseases such as obesity, type 2 diabetes, and cardiovascular disease. This narrative review summarizes the nutritional composition of edible seaweeds; evaluates the evidence regarding the health benefits of whole seaweeds, extracted bioactive components, and seaweed-based food products in humans; and assesses the potential adverse effects of edible seaweeds, including those related to ingestion of excess iodine and arsenic. If the potential functional food and nutraceutical applications of seaweeds are to be realized, more evidence from human intervention studies is needed to evaluate the nutritional benefits of seaweeds and the efficacy of their purported bioactive components. Mechanistic evidence, in particular, is imperative to substantiate health claims.

Scientific Evidence on Functional Food and Its Commercial Communication: A Review of Legislation in Europe and the USA.

This study aims at understanding how scientific evidence to substantiate nutrition and health claims in food commercial communication is regulated in Europe and the USA. A literature review was performed on the scientific evidence required by the European Food Safety Authority and the US Food and Drug Administration to substantiate food nutrition and health claims. Studies published in Scopus, Medline, Scirus, and Google Scholar from 2007 to 2012 were reviewed as well as documents released by both agencies. A total of 38 documents met our inclusion criteria out of 743 documents initially identified during our search. These agencies provide general guidelines on how to conduct food and health studies, intended to demonstrate a cause-and-effect relationship between a given food and a benefit to health. Despite this, they need to broaden the depth and scope of the guidelines provided to companies seeking to substantiate their claims and to provide further and more precise information concerning the evaluation of studies and application processes. No review has hitherto specifically focused on the subject of scientific evidence required by EU and US food agencies to substantiate health claims. This research thus leads to significant recommendations on how to improve current food industry guides.

Nutraceuticals: opening the debate for a regulatory framework.

Currently, nutraceuticals do not have a specific definition distinct from those of other food‐derived categories, such as food supplements, herbal products, pre‐ and probiotics, functional foods, and fortified foods. Many studies have led to an understanding of the potential mechanisms of action of pharmaceutically active components contained in food that may improve health and reduce the risk of pathological conditions while enhancing overall well‐being. Nevertheless, there is a lack of clear information and, often, the claimed health benefits may not be properly substantiated by safety and efficacy information or in vitro and in vivo data, which can induce false expectations and miss the target for a product to be effective, as claimed. An officially shared and accepted definition of nutraceuticals is still missing, as nutraceuticals are mostly referred to as pharma‐foods, a powerful toolbox to be used beyond the diet but before the drugs to prevent and treat pathological conditions, such as in subjects who may not yet be eligible for conventional pharmaceutical therapy. Hence, it is of utmost importance to have a proper and unequivocal definition of nutraceuticals and shared regulations. It also seems wise to assess the safety, mechanism of action and efficacy of nutraceuticals with clinical data. A growing demand exists for nutraceuticals, which seem to reside in the grey area between pharmaceuticals and food. Nonetheless, given specific legislation from different countries, nutraceuticals are experiencing challenges with safety and health claim substantiation.

Insulin resistance as key factor for linking modulation of gut microbiome to health claims and dietary recommendations to tackle obesity

BackgroundCurrent dietary and public health recommendations addressing obesity do not as yet include recommendations pertaining to the gut microbiome. As a corollary, no microbiome-related health claims made on foods have as yet been proposed. ScopeThe MyNewGut project aims, amongst others, to provide guidance for the establishment of dietary and public health recommendations related to the role microbiome in the onset and development of obesity. Moreover, the project's forthcomings should allow the compilation of a guidance document for microbiome-related health claims. Key findingsOf all the physiological effects resulting from changes in the microbiome, insulin resistance is the most direct diet-modifiable parameter related to obesity. Improving insulin resistance is considered to be the key health benefit conferred by the targeted modulation of the gut microbiome, through the development and application of foods containing microbiome-targeted fibers and micro-organisms. ConclusionsIn order to facilitate guidance for the development of public health and dietary recommendations, as well as for health claim substantiation related to the gut microbiome, foods containing microbiome-targeting dietary fibers and microorganisms will be developed and studies with these foods should provide for the total body of clinical evidence specifically addressing the central theme of ‘insulin resistance’ in obesity, still leaving ample room for the inclusion of other parameters of interest. The latter is pivotal since an impact of other parameters on obesity should be addressed as well, particularly in view of the multifaceted modes of action of the microbiome.

Determination of d-glucaric acid and/or d-glucaro-1,4-lacton in different apple varieties through hydrophilic interaction chromatography

d-Glucaric acid (GA) derivatives exhibit anti-cancerogenic properties in vivo in apples, but quantitative information about these derivatives is limited. Hydrophilic interaction-based HPLC with ultraviolet detection or mass spectrometry was developed to quantify GA and/or d-glucaro-1,4-lacton (1,4-GL) in apples. Although the formation of 1,4-GL from GA could be the prerequisite to exert biological effects in vivo, only a small portion of GA (<5%) was identified and converted to 1,4-GL in the rat stomach. The 1,4-GL content in apples ranged from 0.3mg/g to 0.9mg/g, and this amount can substantiate health claims associated with apples. The amount of 1,4-GL was 1.5 times higher in Gala and the ratio of 1,4-GL to GA was lower in Green Delicious apples than those in the other varieties. Our findings suggested that the variety and maturity of apples at harvest are factors that determine 1,4-GL content.

A review of the systematic review process and its applicability for use in evaluating evidence for health claims on probiotic foods in the European Union.

This paper addresses the use of systematic review and meta-analysis to evaluate the strength of evidence for health benefits of probiotic foods, especially relating to health claim substantiation in the European Union. A systematic review is a protocol-driven, transparent and replicable approach, widely accepted in a number of scientific fields, and used by many policy-setting organizations to evaluate the strength of evidence to answer a focused research question. Many systematic reviews have been published on the broad category of probiotics for many different outcomes. Some of these reviews have been criticized for including poor quality studies, pooling heterogeneous study results, and not considering publication bias. Well-designed and -conducted systematic reviews should address such issues. Systematic reviews of probiotics have an additional challenge – rarely addressed in published reviews - in that there must be a scientifically sound basis for combining evidence on different strains, species or genera. The European Food Safety Authority (EFSA) is increasingly adopting the systematic review methodology. It remains to be seen how health claims supported by systematic reviews are evaluated within the EFSA approval process. The EFSA Panel on Dietetic Products, Nutrition and Allergies deems randomized trials to be the best approach to generating evidence about the effects of foods on health outcomes. They also acknowledge that systematic reviews (with or without meta-analyses) are the best approach to assess the totality of the evidence. It is reasonable to use these well-established methods to assess objectively the strength of evidence for a probiotic health claim. Use of the methods to combine results on more than a single strain or defined blend of strains will require a rationale that the different probiotics are substantively similar, either in identity or in their mode of action.

Cause-effect relationships in nutritional intervention studies for health claims substantiation: guidance for trial design

The growing worldwide interest on functional food research has been accompanied by increasing regulatory guidelines in this area, with the aim of ensuring that any claimed effect in foods, beyond their nutritional role, is based on scientific unequivocal evidence. In order to assess the cause-effect relationship between the regular consumption of a food or a food component and the beneficial outcome for the consumer, an appropriate study design is required. Previous knowledge and research on the specific claimed food or product may be an adequate basis for defining a hypothesis and accurate objectives. Other key factors to take into account are based on the outcomes studied, the length of the trial, sample size and type, as well as the transparency on reporting the results obtained. Based on the Consolidated Standards on Reporting Trials statement (CONSORT), together with the specific guidelines published by the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies, the present article aims at summarizing key questions conducting to the most appropriate study design for solid health claim substantiation.

Stimulus-based inferences about the scientific substantiation of health claims on food

Purpose – This paper aims to examine the effects of qualifying language, functional ingredient, ingredient familiarity and inferences of manipulative intent (IMI) on the likelihood that consumers make stimulus-based inferences about the level of scientific support for health claims on food. Design/methodology/approach – An advertisement copy test for a fictitious product bearing a caries risk-reduction claim has been conducted. The test design comprises three claim conditions, each corresponding to one of the sufficient levels of support for nutrient-health relations within the World Health Organization (WHO)-framework. Findings – The claim conditions have affected the likelihood of making stimulus-based inferences, which is lower for high-level-of-support claims as opposed to low-level-of-support and moderate-level-of-support claims. No effect of ingredient familiarity has been observed. The effect of the functional ingredient featured is significant at the 10 per cent-level. IMI has a negative effect on the likelihood of making a stimulus-based inference. Research limitations/implications – The survey relies on a demographically homogeneous sample. Practical implications – Examining the likelihood of stimulus-based inferences about health claim substantiation is essential for assessing the effectiveness of claim formulations and for addressing resulting miscommunication. Originality/value – The current paper addresses the research gap on consumer ability to identify the level of support for health claims within the European context.

Implementation of the nutrition and health claim regulation – The case of antioxidants

This article analyses the consequences of the implementation of the nutrition and health claim regulation in the field of food products containing antioxidants or food products claiming antioxidant activity. To this end, it first examines the origin and creation of the regulation and the involvement of EFSA in assessing scientific substantiation of health claims. Three criteria are regarded as critical in EFSA’s opinions on the scientific substantiation of a health claim: the claimed effect (i) is well defined; (ii) is a clear beneficial physiological effect; and (iii) shows a cause effect relationship with the consumption of the food or functional ingredient. These criteria have implications for the research requested to substantiate health claims, although these implications do not all seem to fit nutrition research as it is currently executed. Looking at antioxidants, the complexity of the mechanisms and actions of antioxidants is not recognised by the criteria used to evaluate proposed health claims, nor by the methodologies used to assess the effects of antioxidants. These criteria should be adjusted with novel scientific insights after consulting stakeholders.

Establishing and evaluating health claims for probiotics.

Establishing and evaluating health claims for probiotics.

Science and technology for the mastership of probiotic applications in food products

Probiotics, defined as live microorganisms which when consumed in adequate amounts confer a health benefit on the host, are a common part of our daily diet. Since their conception in the early 20th century, the health benefit applications of probiotics have been expanding, culminating in the recent challenge of health claim substantiation in Europe. This paper highlights the different application areas of probiotics, introduces the use of non-viable microorganisms to confer health benefits, and explains the recent regulatory challenges surrounding probiotics. It then describes in detail the different stages in the development of food products containing probiotic bacteria starting from the selection of suitable strains for industrial production. The description of production of probiotic powders with specific focus on strategies to maintain high viability during drying and storage then follows. The paper finishes with a discussion of probiotic stability in liquid products, followed by a description of the use of probiotics to improve nutrient bioavailability and digestibility of the food products, which they ferment or biotransform.

Health claims on foods: challenge for clinical research companies

BackgroundThe Nutrition and Health Claim Regulation 1924/2006/EC, together with EFSA guidances on the scientific requirements for different type of health claims, is setting the basis for health claim substantiation in the EU.AimThe aim of this presentation is to bring up the key challenges that the food industry and clinical research organizations are facing when meeting these requirements.Results and discussionKey issues in clinical research planning to meet the requirements set for the health claim substantiation are: (1) Selection of right outcome markers since the selection of outcome marker defines actually the formulation of the health claim to be used on food or food ingredient. (2) Selection of right target population since that determines the target consumer group for the food with a health claim. (3) Selection of dose regime and food matrices used since these largely determine the conditions set for the use of the health claim. One of the major challenges in health claim substantiation is the deviant approach to risk factors or biomarkers. From the regulation point of view, a single risk factor approach is emphasized, but from the clinical and scientific point of view the pattern of different risk markers or biomarkers could, in some cases, be a more relevant choice to reflect the final health outcome. This is especially the case in the nutrition and health area because we are often dealing with weak but multiple health effects of certain food items or ingredients. Also the lack of validated well-established biomarkers potent to be affected by diet is a challenge in health claim substantiation.The selection of right target population is often a compromise between choosing a more potential target group to obtain efficacy (i.e. risk factors elevated vs. patient groups) and choosing a rationale to generalize the results to wider population (target consumer) group.The selection of optimal dosing regime and matrices for a clinical study is partly dependent on previous scientific data on the dose response, if existing. But equally important is the choice of feasible doses from product formulation and food consumption point of view.ConclusionWith careful analysis of the existing data, advance planning and clinical research strategy it is possible to build up a health claim substantiation that meets the requirements both of Nutrition and Health Claim Regulation and EFSA.

Probiotics and prebiotics: health claim substantiation.

‘Probiotics’ and ‘prebiotics’ by definition should have health benefits. Health claims on microorganisms proposed as probiotics and probiotic stimulating agents (prebiotics) suggest that there is a relationship between the specific food and maintaining good health or that the food can reduce the risk of a disease. The Health Claim Regulation in European Union aims at a level consumer protection. Thereby, health claim assessment focuses on defining the probiotics and prebiotics, assessing the health relationship and evaluating studies with emphasis on controlled human intervention studies. The challenges include the focus of claims for healthy populations while most intervention studies with probiotics and prebiotics have been conducted in patients or subjects at risk of specific diseases. Another challenge is the risk reduction claim, which requires demonstrated changes in biomarkers that are generally accepted as indicators of disease risk. Existing assessment opinions from EFSA illustrate the need for further research for probiotics and prebiotics in the future.

Generic and Product-Specific Health Claim Processes for Functional Foods across Global Jurisdictions 3

Worldwide consumer interest in functional foods and their potential health benefits has been increasing over the past 10 y. To respond to this interest, regulatory bodies have developed guidelines for assessing health claims on functional foods. The objective of this article is to investigate the type and amount of evidence needed in various jurisdictions on a worldwide basis to substantiate both generic and product-specific health claims. Two types of health claims were examined using separate case studies. Analysis of generic health claims was highlighted by (n-3) fatty acids and their relation to heart health; whereas examination of product-specific health claims was conducted using probiotics and their association with gastrointestinal well-being. Results showed a common core for use of convincing high-quality human data, especially in the form of randomized controlled trials (RCT), but there was significant variability in the type and amount of scientific evidence needed to substantiate health claims, both generic and product specific, across different jurisdictions. Product-specific claims tended to use human RCT as the main basis for claims, whereas generic claims tended to base their statements on a wider spectrum of literature.

Immunomodulatory effects of probiotics in different stages of life

The immunomodulatory properties of lactic acid bacteria (LAB) and foods containing them (e.g., fermented milks) is a topic currently under investigation. Individuals could potentially benefit from the inclusion of LAB in the diet at different times during the life cycle. One of the most accepted specific uses of probiotic bacteria is the prevention of atopic eczema in infants with family history of the disease who receive the probiotic bacteria early, through supplementation of the gestating mother and orally after birth. Immune enhancing effects have also been suggested to be beneficial in diarrhoea treatment, especially in children infected with rotavirus and in malnourished patients, infants and adolescents, whose capacity to produce IFN-gamma can be increased after LAB-containing yoghurt intake. Regarding young people and adults, investigations have been conducted exploring the immunomodulation by LAB in subjects under stressful situations, in the prevention of urinary tract infections in fertile women and in the treatment of allergy. However, the beneficial effects of probiotics in these conditions remain controversial and the scientific evidence provided so far is not considered to be conclusive. The elderly population has been the focus of investigations aimed at identifying the capacity of probiotics to counteract the immunosenescence process by increasing phagocytic and natural killer (NK) cell activities and to protect against infection. The mechanisms involved in the different effects attributed to LAB remain to be clarified. Moreover, considering that the immunomodulatory properties are strain-specific, defining the optimal dose of a certain bacteria or combination of bacteria strains and the duration of treatment for a desired effect in a target population group is essential in order to substantiate health claims.

Functional foods: concepts and application to inulin and oligofructose.

A food can be regarded as functional if it is satisfactorily demonstrated to affect beneficially one or more target functions in the body, beyond adequate nutritional effects, in a way which is relevant to either the state of well-being and health or the reduction of the risk of a disease. Health claims are expected to be authorized for functional foods based either on enhanced function (type A claim) or disease risk reduction (type B claim). Their development is a unique opportunity to contribute to the improvement of the quality of the food offered to consumer's choice for the benefit of his well-being and health. But only a rigorous scientific approach producing sound data will guarantee its success. The functional food components that are discussed in the proceedings of the 3rd ORAFTI Research Conference are the inulin-type fructans, natural food components found in miscellaneous edible plants. They are non-digestible oligosaccharides that are classified as dietary fiber. The targets for their functional effects are the colonic microflora that use them as selective 'fertilizers'; the gastrointestinal physiology; the immune functions; the bioavailability of minerals; and the metabolism of lipids. Potential health benefits may also concern reduction of the risk of some diseases like intestinal infections, constipation, non-insulin dependent diabetes, obesity, osteoporosis or colon cancer. The present proceedings review the scientific data available and, by reference to the concepts in functional food science, they assess the scientific evidence which will be used to substantiate health claims.

Functional foods: concepts and application to inulin and oligofructose

A food can be regarded as functional if it is satisfactorily demonstrated to affect beneficially one or more target functions in the body, beyond adequate nutritional effects, in a way which is relevant to either the state of well-being and health or the reduction of the risk of a disease. Health claims are expected to be authorized for functional foods based either on enhanced function (type A claim) or disease risk reduction (type B claim). Their development is a unique opportunity to contribute to the improvement of the quality of the food offered to consumer's choice for the benefit of his well-being and health. But only a rigorous scientific approach producing sound data will garantee its success. The functional food components that are discussed in the proceedings of the 3rd ORAFTI Research Conference are the inulin-type fructans, natural food components found in miscellaneous edible plants. They are non-digestible oligosaccharides that are classified as dietary fiber. The targets for their functional effects are the colonic microflora that use them as selective ‘fertilizers’; the gastrointestinal physiology; the immune functions; the bioavailability of minerals; and the metabolism of lipids. Potential health benefits may also concern reduction of the risk of some diseases like intestinal infections, constipation, non-insulin dependent diabetes, obesity, osteoporosis or colon cancer. The present proceedings review the scientific data available and, by reference to the concepts in functional food science, they assess the scientific evidence which will be used to substantiate health claims.

Staking a claim

Staking a claim