Cis-9-cetylmyristoleate (CMO) is a naturally occurring fatty acid complex (FAC). Nutraceuticals containing CMO are used to improve knee pain despite the lack of placebo-controlled studies in humans. The aim of the double-blind controlled clinical trial is to explore the minimal effective dose of CMO for relieving knee joint pain.
Methods: Twenty-eight subjects, who are clinically or radiologically diagnosed as having mild degree arthritic knee joint pain, are randomized into 3 groups; Groups A, B, C that contained 100%, 80%, and 62.4% of fatty acid component with 12.5% of Cis-9-cetylmyristoleate (CMO), and control Group D (starch 100%). The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
62.4% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
CHANGE of Pain
using the NRS score, composed of an 11-point scale from 0 (no pain) to 10 (the worst pain possible)
Time frame: change from baseline at 3 months
difference in NRS pain score from baseline within groups
Time frame: at 1-month follow-up, at 2-month follow-up, and at 3-month follow-up
change of the WOMAC score
using the Korean version of WOMAC
Time frame: change from baseline at 3 months
Global Impression of Change
a scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: at 3-month follow-up
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0% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate