A Clinical Trial to Investigate the Efficacy and Safety of a Plant-derived Cetylated Fatty Acids … (NCT07695714) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Trial to Investigate the Efficacy and Safety of a Plant-derived Cetylated Fatty Acids (CFA) on Knee Pain and Stiffness in Healthy Adults With Persistent Knee Pain
Canada80 participantsStarted 2026-07
Plain-language summary
The goal of this clinical trial is to investigate the efficacy and safety of plant-derived cetylated fatty acids (CFA) on joint health and mobility in adults with persistent knee pain. The main question it aims to answer is what is the change from baseline to day 42 in knee joint health, as assessed by the KOOS pain sub-scale scores, between plant-derived cetylated fatty acids (CFA) and placebo? Researchers will compare plant-derived cetylated fatty acids (CFA) with placebo to evaluate its effects on joint health, mobility, pain, and stiffness. Participants will be asked to:
* Consume plant-derived cetylated fatty acids (CFA) or placebo daily from Day 1 until the day before the end-of-study visit
* Have height, weight, heart rate, and blood pressure measurements taken
* Complete the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
* Complete the 6-Minute Walk Test (6MWT)
* Complete the 30 seconds chair sit to stand test
* Complete the pain and stiffness Likert scale
* Complete the subject treatment diary daily
Who can participate
Age range
35 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males \& females between 35 and 75 years of age
. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
. A history of symptomatic knee discomfort, defined as experiencing pain in the target knee on most days of the month (≥ 15 days/month) for at least the past 3 months
. A KOOS Pain Subscale score ≥25 and ≤75
. Target knee is the primary source of lower-limb pain limiting walking and daily function, as confirmed by the QI
. A KOOS Function in daily living (ADL) score ≥25 and ≤ 80
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to day 42 in knee joint health
. Travel less than 85% of predicted distance on the 6MWT as calculated using the Enright and Sherrill equation at screening (15)
. Agrees to refrain from taking any pain relievers during the study, except acetaminophen as a rescue medication specified by the study site
Exclusion criteria
. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product, placebo, or rescue medication ingredients
. Individuals with a Body Mass Index (BMI) \>34.9
. Prior clinician diagnosis (confirmed via x-ray) of knee OA or evidence of OA (e.g. severe deformity/constant pain) or confounding pain condition such as fibromyalgia
. Intra-articular injection of corticosteroids or hyaluronic acid in either knee within 3 months prior to the Baseline visit
. Change in knee pain/stiffness/mobility treatment (e.g. physical therapy, braces, orthotics) in the past two months, as assessed by the QI
. Use of any assistive device for walking/mobility
. Any knee surgery within the past 6 months, or planned knee surgery within the study duration