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OpenTrials
Completed

NCT Number: NCT02800759

Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JOINTRUS®

Dietary Supplement

100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate

Other names: 100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate

80% dose of JOINTRUS®

Dietary Supplement

80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate

Other names: 80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate

62.4% dose of JOINTRUS®

Dietary Supplement

62.4% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate

Starch 100%

Dietary Supplement

0% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 15, 2016
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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