Journal
OSTEOPOROSIS INTERNATIONAL
Volume 23, Issue 1, Pages 193-199Publisher
SPRINGER LONDON LTD
DOI: 10.1007/s00198-011-1561-x
Keywords
Bone; Health claim; Nutrition; Surrogate
Categories
Funding
- GlaxoSmithKline
- IBSA
- MSD
- Novartis
- Rottapharm
- Servier
- Theramex
- Wyeth
- Danone
- Greentech
- Lesieur
- Rousselot
- Negma
- Amgen
- Roche
- Nycomed
- UCB
- Expanscience
- Lundbeck
- Janssen Cilag
- Horus
- Eli Lilly
- Merck Sharpe Dohme
- Novo Nordisk
- Procter Gamble
- Sanofi-Aventis
- Flemish Fund for Scientific Research
- Lilly
- Merckle
- NPS
- Genevrier
- Teijin
- Teva
- Ebewee Pharma
- Zodiac
- Analis
- Bristol Myers Squibb
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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. Introduction 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. Methods 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). Results 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. Conclusion 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.
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