A food product with an effect on bone microarchitecture could have the claim: “X improves (or maintains) bone microarchitecture that could contribute to the normal Rabusertib mw structure and function of bones”. It is considered that the assessment of bone structure with the tools currently available in man is not sufficiently validated to be a reliable surrogate of bone strength. For this reason, animal models are needed to assess the relationship between changes in bone microarchitecture induced by the food product and any increase in bone strength. A food product with an effect on microarchitecture of the

human bone and animals studies that show improvement in bone strength or show the relationship between change in bone structure induced by the food product and bone strength could have the claim: “X improves bone microarchitecture that increases bone strength” or “X increases bone strength”   5. Maintenance or

increase selleck chemicals in bone mineral density Bone strength is determined by many factors, including bone mass. Bone mass is estimated in clinical practice by the measurement of BMD. BMD, as measured by DXA, represents an estimate of the quantity of mineral (grams of calcium) divided by the ML323 research buy two-dimensional area of the bone [22]. There is a strong relationship between the risk of fracture and BMD but there is a wide overlap in the bone densities of patients who develop a fracture and those who do not. Since BMD is only a surrogate marker for stiripentol bone strength or fracture risk, and since

product-induced changes in BMD are not clearly associated with changes in bone strength or fracture risk, an increase in BMD may not be associated with an increased bone strength or decreased fracture risk [23]. A food product with a positive effect on BMD could have the claim: “X increases BMD. A low BMD is associated with an increased risk of fracture” or “X maintains BMD. A low BMD is associated with an increased risk of fracture”. Animal models are appropriate to determine whether an increase in BMD associated with a food product is accompanied by an increase in bone strength. A food product with a positive effect on BMD, together with animal studies showing an improvement in bone strength or showing a relationship between BMD changes induced by the food product and bone strength, could have the claim: “X increases (or maintains) BMD that could reduce the risk of fracture” or “X increases (or maintains) BMD that increases bone strength” or “X increases bone strength”.   6. Reduction of the risk of fracture A reduction of the incidence of fracture is a major aim of food products beneficial to skeletal health, but according to the regulation cannot be claimed as such without mentioning the effect on a risk factor. However, a reduction in the fracture risk is obviously supportive for a claim on the reduction of an identified risk factor.