Taiwan FDA announced that it has drafted a new list of health functional claims that health foods can make, with the addition of knee join protection claim.
Once finalised, there will be a total of 14 functional claims that health foods can make. Existing claims include anti-fatigue, bone protection, blood lipids regulation, and liver protection.
At the same time, it has drafted a set of methods for companies to evaluate the efficacy of their products making “knee joint protection” claims.
Once a product has being evaluated based on the methods and approved by the authorities, they will be only to make claims such as “can help to alleviate mild knee joint discomfort”.
The FDA is currently seeking public consultation on the newly added claim as well as the evaluation methods drafted. The public consultation ends on April 15.
Intervention of at least 12 weeks
As part of the evaluation, a clinical trial with an intervention period of at least 12 weeks should be carried out.
This should also be a randomised, double-blind, parallel design, where test subjects are equally randomised to take either the placebo or intervention.
The dosage used for the intervention should include the recommended dose for the commercialised product.
Aside from knee joint related parameters, the trial should also look into the safety of the intervention, with blood tests and analysis conducted.
Inclusion and exclusion criteria
The draft has also stated the recruitment and exclusion criteria for test subjects.
One of which is that the test subjects should be between the age of 45 to 80.
Based on the Ahlbäck classification – which measures the extent of knee osteoarthritis – these subjects should be at either stage I or stage II, where signs of arthritis is still at the preliminary stage.
At stage II for example, there is the obliteration of the joint space but not yet bone defect as seen in stage III to V.
The test subjects can also be recruited based on the Kellgren-Lawrence grading scale, also a method for evaluating the severity of osteoarthritis.
In this case, their symptoms should be below grade III. There are a total of five grades under the Kellgren-Lawrence grading scale, the higher the grading, the more severe the symptoms.
The subjects to be recruited should also score three points and below on the visual analogue scale – a tool for rating the intensity of pain.
Their WOMAC (Western Ontario and McMaster Universities Osteoarthritis) pain score should also be below two, or less than 12 for their total WOMAC score.
Exclusion criteria, on the other hand, include individuals who are 40kg/m2 and above in their body mass index (BMI).
People suffering from “serious” cardiovascular, cerebrovascular, and rheumatic disease are also to be excluded.
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