To the Editor:
In 2013, my colleagues and I demonstrated that healthy adults supplemented with UC-II® undenatured type II collagen presented with improved post-exercise knee extension and comfort [
1]. In 2016, we described similar benefits for joint comfort, flexibility, and physical function in adults with knee osteoarthritis [
2]. The investigational materials used in both studies derived from commercial batches characterized using a sensitive enzyme-linked immunosorbent assay (ELISA) method adapted from published procedures [
3].
In between the publication of these two trials, we updated our extraction method in order to reduce the overall time required for quantifying the amount of undenatured collagen type II. While this new method offers time saving advantages, due to the shorter extraction time, the new assay may indicate lower collagen type II levels. However, the method is sufficient to confirm the minimum specification requirements for this ingredient. As a result, the different assay methods yield differing amounts of undenatured type II collagen for the same material tested (Table
1).
Table 1
Comparison of Assay Methods Characterizing UC-II® Undenatured Type II Collagen
Efficacy study - healthy adults* | 1109006 | 10.8 mg (27.0%) | 2.3 mg (5.8%) |
Efficacy study – people with osteoarthritis ** | 1204004 | 10.8 mg (27.1%) | 1.2 mg (3.0%) |
Typical lot sold into commerce | 1309029 | 10.6 mg (26.5%) | 1.3 mg (3.3%) |
Despite the change in the extraction protocol, it is important to note that the UC-II® undenatured type II collagen material itself has not changed. The material used in these clinical studies is produced using the same manufacturing processes that have been in place over the past 14 years.
The total collagen assay, developed under Good Laboratory Practices and validated per ICH guidelines, offers key advantages over the previously used ELISA method. Overall, the new assay is a faster, more straightforward procedure that is easily transferable to other laboratories.
In summary, the UC-II® material used in the published clinical research and the commercially available ingredient remains identical. The only change is to the extraction method used to prepare the UC-II® undenatured type II collagen material prior to ascertaining its percentage of undenatured type II collagen.
Acknowledgements
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