The bone health area is doing slightly better in this regard than joint-related claims. According to Ripoll, 15 vitamin, protein and mineral claims relating to bone health have been given a positive opinion by the European Food Safety Authority (EFSA). There have been two claims upheld for vitamins and minerals in the joint health area.
In most cases, he reports, these were well-established claims regarding ‘maintenance’ roles in either strong bones or connective tissues such as collagen in joints.
“But over 100 other claims in these health areas were rejected,” says Ripoll. “In many cases, this was because the trials were carried out on unhealthy populations or with a design not in relation to the claimed effect.”
EFSA has made it fairly clear what scale of clinical trial it requires to support a particular health claim. It has also emphasised the importance of trials using healthy subjects. In other words, a measurable therapeutic impact on patients already suffering from osteoarthritis will not be taken as evidence of disease prevention or risk reduction in a healthy population.
So how to measure this type of risk reduction? In some other health areas, there are fairly well-accepted biomarkers (see box), such as cholesterol as a measure of cardiovascular health. However joint health, particularly with reference to the development of osteoarthritis, is one of those areas where accepted biomarkers are more elusive.
Cutting trial times
Of course, another option would be to monitor healthy individuals to ascertain how many developed a given condition. In the case of osteoarthritis, that might necessitate a fairly long trial (from two up to 30 years). Given the emphasis, also, on larger populations for statistical significance, the budgets (quite apart from the patience) of clients are unlikely to stretch that far.
When it comes to bone health, BMD measured appropriately would indicate progress towards osteoporosis. This is an approach, in conjunction with a study duration of at least one year, validated by EFSA. One huge advantage of a proven biomarker is that it can minimise trial duration while maximising scientific evidence.
At Glanbia, Ward points to an Irish study some three years ago that indicated positive effects of TruCal on two different biomarkers of bone resporption – the parathyroid hormone and a collagen degradation marker. Other research has linked the mineral blend with reductions in urine helical peptide and bone alkaline phosphatase, suggesting a decrease in the loss of bone mass.
“A lot of the time, we’ll be looking at more than one biomarker, a series or cascade of markers all of which link back to the effects we are interested in,” says Ward.
Brown at DSM adds a cautionary note regarding the way in which evidence on bone health is collected. “The difficulty in monitoring bone remodelling is that it consists of two apparently contradictory processes, which are bone resorption and formation,” he says. “These two interlinked processes work in parallel and – at specific sites – also sequentially, but the biological markers for each are different. So you’re taking a snapshot of one moment, but you don’t know where you are on the curve. You need to see the broader picture.”
Finally, there are some even more obscure connections when it comes to bones and joints which, longer-term, could have a telling impact on pharmaceutical and nutraceutical ingredient options.
“There seems to be a link between obesity and the development of osteoarthritis,” says Ripoll at Naturalpha. “Possibly also with osteoporosis – there’s good scientific evidence that this is related to osteoarthritis.”
There may be an even deeper structure to all this. “The common stem cell lineage of adipocytes (fat cells), chondrocytes (cartilage), muscle and bone cells is also being investigated to better understand the origin of osteoarthritis and in order to identify biomarkers,” he says.
Could there be some sort of common origin, and could there be a correlation when it comes to health, too? Our ‘toe bone’, it appears, might after all be connected to far more than just our ‘foot bone.
