PASSCLAIM: diet-related cancer

The strongest markers presently available are precancerous lesions (e. g. polyps or aberrant crypt foci) in humans and precancerous lesions and tumours in animal models. The only marker that presently can be used for a 'reduction of disease risk' claim (type B) for food components is 'polyp recurrence'. Type B claims cannot be made on the basis of results in animal models. All of the other biomarkers examined presently lack validation against the 'true endpoint', the tumour, and thus cannot be used for type B claims. 'Reduction of disease risk' claims in the area of 'diet-related cancer' should be based primarily on human intervention studies using relevant/acceptable endpoints. An important area for future research will be the validation of these surrogate endpoints

PASSCLAIM - Bone health and osteoporosis

Summary. Background: The EC Concerted Action PASSCLAIM aims to produce a generic tool for assessing the scientific support for health-related claims for foods and food components. Aim: The task of the ITGB Working Group was to critically evaluate the categories of scientific evidence needed to support claims in relation to bone health and osteoporosis. Methods: A framework was developed to describe the chain of evidence that is required to link the consumption of a food or food component to bone health outcomes. Techniques available for interrogating each link in the chain were identified and their strengths and weaknesses considered. This framework was used to determine intermediate markers of health outcome with respect to osteoporosis and to debate the level of evidence that would be required to substantiate claims of enhanced function or reduced disease risk. Results: Use of this framework with osteoporotic fracture as the health endpoint resulted in the following judgements based on current knowledge: 1) bone mineral density (BMD) is an intermediate marker of bone health which, for people of any age and sex, can provide evidence of enhanced function; 2) for people over 50 years living in populations with a high incidence of fracture, BMD is an intermediate marker of osteoporotic fracture risk which can provide evidence of an increased probability of reduced disease risk; 3) because osteoporosis is defined as a state of increased fracture risk due to low bone mass and deterioration in bone microarchitecture, a claim of a definite reduction in osteoporosis or fracture risk requires similar substantiation to claims that fractures are prevented or treated, including clinical trials and animal studies; 4) data from lower in the chain of evidence, such as bone turnover and calcium bioavailability, are not, by themselves, sufficiently strongly related to bone health endpoints to provide evidence of enhanced function or reduced disease risk but can provide supporting information. Conclusions: In the light of existing scientific knowledge, a framework has been developed as a tool for considering the scientific support for claims relating to bone health and osteoporosis. To provide a working example, the framework has been used to assess the current position with osteoporotic fracture as the health endpoint. This experience will contribute to the formulation under PASSCLAIM of a generic tool for assessing the scientific support of health claims on foods

PASSCLAIM--body weight regulation, insulin sensitivity and diabetes risk

BACKGROUND: Insulin sensitivity is a key function in human metabolism because it has a crucial role in the development of disease that are increasingly common in modern society. Impaired insulin sensitivity is an important determinant of type 2 diabetes; moreover, it has been proposed as an independent risk factor for cardiovascular disease. Thus, reduced insulin sensitivity is strongly associated with the metabolic syndrome, which represents a cluster of metabolic abnormalities and cardiovascular risk factor. Insulin sensitivity can be modulated by different environmental factors, including dietary habits. Obesity, especially if associated with abdominal adiposity, impairs insulin-sensitivity while physical activity can improve it; however, the composition of the habitual diet is clearly an important regulator of this function. AIM: To evaluate methodologies and markers that can be used to substantiate existing and potential claims of beneficial effects of foods on relevant functions connected with body fat deposition, insulin sensitivity and blood glucose regulation. RESULTS: We have reviewed the scientific basis for existing and potential claims, based not only on modifications of the target functions (body fat deposition, insulin sensitivity and blood glucose regulation) but also on modifications of other relevant associated functions (energy intake, energy expenditure, fat storage and oxidation, lipotoxicity, body fat composition, inflammation, oxidative stress, vascular function, glucose production and utilization). In this context we have identified a number of markers and evaluated appropriate method to measure and validate them. CONCLUSIONS: Relevant functions contributing to overweight, the metabolic syndrome and diabetes have been identified. The evidence reviewed indicates that in this field the link between nutrition, biological responses and diseases is clearly established. Therefore, there is a strong potential to develop functional food science. The major gap in the evidence continues to be the lack of diet based intervention trials of sufficient duration to be relevant for affecting the natural history of these conditions