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

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ClinicalTrials.gov Identifier: NCT02800759
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Jeeyoun Moon, Seoul National University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Pain Intermittent Dietary Supplement: JOINTRUS® Dietary Supplement: 80% dose of JOINTRUS® Dietary Supplement: 62.4% dose of JOINTRUS® Dietary Supplement: Starch 100% Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Minimal Effective Dose of Cis-9-cetylmyristoleate (CMO) in Persons Presenting With Knee Joint Pain
Study Start Date : September 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Active Comparator: 100% of JOINTRUS®
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®
100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
Other Name: 100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate

Active Comparator: 80% of JOINTRUS®
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®
80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
Other Name: 80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate

Active Comparator: 62.4% of JOINTRUS®
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®
62.4% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate

Placebo Comparator: Starch 100%
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%
0% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate




Primary Outcome Measures :
  1. CHANGE of Pain [ Time Frame: change from baseline at 3 months ]
    using the NRS score, composed of an 11-point scale from 0 (no pain) to 10 (the worst pain possible)


Secondary Outcome Measures :
  1. 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 ]
  2. change of the WOMAC score [ Time Frame: change from baseline at 3 months ]
    using the Korean version of WOMAC

  3. Global Impression of Change [ Time Frame: at 3-month follow-up ]
    a scale ranging from 1 (very much improved) to 7 (very much worse).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Publications:

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Responsible Party: Jeeyoun Moon, Clinical Associate Professor, Seoul National University
ClinicalTrials.gov Identifier: NCT02800759    
Other Study ID Numbers: 1307-098-506
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms