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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Knee Pain Intermittent

Intervention / Treatment
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* Dietary Supplement: JOINTRUS®
* Dietary Supplement: 80% dose of JOINTRUS®
* Dietary Supplement: 62.4% dose of JOINTRUS®
* Dietary Supplement: Starch 100%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 100% of JOINTRUS®<br>After randomization, 100% dose of JOINTRUS® is taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period. | Dietary Supplement: JOINTRUS®<br>* 100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate<br>* Other names: 100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate;|
| Active Comparator: 80% of JOINTRUS®<br>After randomization, 80% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period. | Dietary Supplement: 80% dose of JOINTRUS®<br>* 80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate<br>* Other names: 80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate;|
| Active Comparator: 62.4% of JOINTRUS®<br>After randomization, 62.4% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period. | Dietary Supplement: 62.4% dose of JOINTRUS®<br>* 62.4% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate<br>|
| Placebo Comparator: Starch 100%<br>After randomization, starch 100% was taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period. | Dietary Supplement: Starch 100%<br>* 0% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE of Pain | using the NRS score, composed of an 11-point scale from 0 (no pain) to 10 (the worst pain possible) | change from baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in NRS pain score from baseline within groups |  | 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 | change from baseline at 3 months | 
| Global Impression of Change | a scale ranging from 1 (very much improved) to 7 (very much worse). | at 3-month follow-up |