Health claims for food products in Europe are permitted if the nutrient has been shown to have a beneficial nutritional or physiological effect. This paper defines health claims related to bone health and provides guidelines for the design and the methodology of clinical studies to support claims.
Regulation (EC) no. 1924/2006 on nutrition and health claims targeting food products was introduced in Europe stating that health claims shall only be permitted if the substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect. The objective of this paper is to define health claims related to bone health and to provide guidelines for the design and the methodology of clinical studies which need to be adopted to assert such health claims.
Literature review followed by a consensus discussion during two 1-day meetings organized by the Group for the Respect of Ethics and Excellence in Science (GREES).
The GREES identified six acceptable health claims related to bone health based on the potential of food products to show an effect on either the bioavailability of calcium or osteoclast regulatory proteins or bone turnover markers or bone mineral density or bone structure or fracture incidence. The GREES considers that well-designed human randomized controlled trial on a relevant outcome is the best design to assess health claims. The substantiation of health claim could also be supported by animal studies showing either an improvement in bone strength with the food product or showing the relationship between changes induced by the food product on a surrogate marker and changes in bone strength.
The consensus reached is that the level of health claim may differ according to the surrogate endpoint used and on additional animal studies provided to support the claim.
Jones PJ, Asp NG, Silva P (2008) Evidence for health claims on foods: how much is enough? Introduction and general remarks. J Nutr 138:1189S–1191S PubMed
Asp NG, Bryngelsson S (2008) Health claims in Europe: new legislation and PASSCLAIM for substantiation. J Nutr 138:1210S–1215S PubMed
Prentice A, Bonjour JP, Branca F, Cooper C, Flynn A, Garabedian M, Muller D, Pannemans D, Weber P (2003) PASSCLAIM—bone health and osteoporosis. Eur J Nutr 42(Suppl 1):I28–I49 PubMed
Gueguen L, Pointillart A (2000) The bioavailability of dietary calcium. J Am Coll Nutr 19:119S–136S PubMed
Brown JP, Albert C, Nassar BA, Adachi JD, Cole D, Davison KS, Dooley KC, Don-Wauchope A, Douville P, Hanley DA, Jamal SA, Josse R, Kaiser S, Krahn J, Krause R, Kremer R, Lepage R, Letendre E, Morin S, Ooi DS, Papaioaonnou A, Ste-Marie LG (2009) Bone turnover markers in the management of postmenopausal osteoporosis. Clin Biochem 42:929–942 PubMedCrossRef
Vasikaran SD, Glendenning P, Morris HA (2006) The role of biochemical markers of bone turnover in osteoporosis management in clinical practice. Clin Biochem Rev 27:119–121 PubMed
Vasikaran SD, Eastell R, Bruyere O, Foldes AJ, Garnero P, Griesmacher A, McClung M, Morris HA, Silverman S, Trenti T, Wahl DA, Cooper C, Kanis JK (2011) Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int 22(2):391–420 PubMedCrossRef
Consensus development conference (1993) Diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 94:646–650 CrossRef
Brandi ML (2009) Microarchitecture, the key to bone quality. Rheumatol Oxf 48(Suppl 4):iv3–iv8 CrossRef
- Assessment of health claims in the field of bone: a view of the Group for the Respect of Ethics and Excellence in Science (GREES)
J. A. Kanis
Neu im Fachgebiet Orthopädie und Unfallchirurgie
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