Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain

The Minimal Effective Dose of Cis-9-cetylmyristoleate (CMO) in Persons Presenting With Knee Joint Pain

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.

Inclusion Criteria:

• sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4.

Exclusion Criteria:

• current medication use related to arthritis;
• current use of FAC containing products;
• clinical or radiological diagnosis as moderate degree arthritis accompanied by peri-articular spur formation, irregular joint margin, and/or subchondral cyst;
• previous history of knee surgery;
• pregnant, breastfeeding, or practicing contraception with reliable methods, or not accepting our guidelines during the research periods;
• major pain other than knee joint pain;
• current treatment of gastritis or gastric ulcer;
• abnormal screening laboratory results;
• major cardiac, renal disease, or disability that could affect adverse effect assessment or interfere with study completion when enrolled;
• history of major procedures or operations that might affect study results;
• enrollment in another clinical trial or human application testing; and
• judged as unsuitable for human application testing.