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

Seoul National University

Status: Completed

Conditions: Knee Pain Intermittent

Treatments: Dietary Supplement: Starch 100%; Dietary Supplement: 80% dose of JOINTRUS®; Dietary Supplement: JOINTRUS®; Dietary Supplement: 62.4% dose of JOINTRUS®

Study type: Interventional

Funder types: Other

Identifiers

NCT02800759

1307-098-506

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 4 patient groups, including a placebo group

100% of JOINTRUS®

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: JOINTRUS®

80% of JOINTRUS®

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: 80% dose of JOINTRUS®

62.4% of JOINTRUS®

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: 62.4% dose of JOINTRUS®

Starch 100%

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Starch 100%