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

A Randomized, Triple-blind, Placebo Controlled, Parallel 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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Pain; Mobility; Joint Health
• Intervention / Treatment: Dietary supplement: Plant-derived cetylated fatty acids (CFA); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Lewis, PhD; Phone Number: 248 1-226-242-4551; Email: elewis@kgkscience.com

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N5Y 5V6
      • KGK Science Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Males & females between 35 and 75 years of age

2. 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,

   Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

   • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
   • Double-barrier method
   • Intrauterine devices
   • Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
   • Vasectomy of partner at least 6 months prior to screening
   • Abstinence and agrees to use contraception if planning on becoming sexually active during the study
3. 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
4. A KOOS Pain Subscale score ≥25 and ≤75
5. Target knee is the primary source of lower-limb pain limiting walking and daily function, as confirmed by the QI
6. A KOOS Function in daily living (ADL) score ≥25 and ≤ 80
7. Travel less than 85% of predicted distance on the 6MWT as calculated using the Enright and Sherrill equation at screening (15)
8. Agrees to refrain from taking any pain relievers during the study, except acetaminophen as a rescue medication specified by the study site
9. Agrees to refrain from taking rescue medication for 48 hours prior to study visits
10. Willingness and ability to complete questionnaires, functional tests, records, and diaries associated with the study and to complete all clinic visits
11. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
12. Provided voluntary, written, informed consent to participate in the study
13. Healthy as determined by medical history as assessed by the Qualified Investigator (QI)

Exclusion Criteria:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product, placebo, or rescue medication ingredients
3. Individuals with a Body Mass Index (BMI) >34.9
4. 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
5. Intra-articular injection of corticosteroids or hyaluronic acid in either knee within 3 months prior to the Baseline visit
6. Change in knee pain/stiffness/mobility treatment (e.g. physical therapy, braces, orthotics) in the past two months, as assessed by the QI
7. Use of any assistive device for walking/mobility
8. Any knee surgery within the past 6 months, or planned knee surgery within the study duration
9. Individuals with muscle or skeletal disorders or other physical or gait disorders that limit mobility/walking beyond what may be caused by the impacted knee, as assessed by the QI
10. History of knee replacement
11. Unstable metabolic disease or chronic diseases as assessed by the QI
12. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
13. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
14. Type I or Type II and controlled Type II diabetes
15. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
16. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
17. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
18. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
19. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
20. Individuals with an autoimmune disease or are immune compromised as assessed by the QI
21. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
22. Use of prescription medical cannabinoid products
23. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
24. Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
25. Alcohol intake average of >2 standard drinks per day as assessed by the QI
26. Alcohol or drug abuse within the last 12 months
27. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and safety of the investigational product
28. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
29. Individuals who are unable to give informed consent
30. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plant-derived cetylated fatty acids (CFA); Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit.	Dietary supplement: Plant-derived cetylated fatty acids (CFA); Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit.
Placebo Comparator: Placebo; Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit.	Dietary supplement: Placebo; Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to day 42 in knee joint health	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	Baseline (day 0) to day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to days 7 and 21 in knee joint health	Change from baseline to days 7 and 21 in knee joint health, as assessed by the KOOS pain sub-scale scores, between plant-derived cetylated fatty acids (CFA) and placebo	Baseline (day 0) to days 7 and 21
Change from baseline to days 7, 21, and 42 in physical functionality and mobility	Change from baseline to days 7, 21, and 42 in physical functionality and mobility, as assessed by the 6MWT, between plant-derived cetylated fatty acids (CFA) and placebo	Baseline (day 0) to days 7, 21, and 42
30 seconds chair sit to stand test	Change from baseline to days 7, 21, and 42 in the 30 seconds chair sit to stand test score between plant-derived cetylated fatty acids (CFA) and placebo	Baseline (day 0) to days 7, 21, and 42
Joint pain/stiffness following mobility challenge	Change from baseline to days 7, 21, and 42 in joint pain/stiffness following mobility challenge, as assessed by Likert Scale, between plant-derived cetylated fatty acids (CFA) and placebo	Baseline (day 0) to days 7, 21, and 42
Rescue medication	Number and proportion of days from baseline to days 7, 21, and 42 on which rescue medication was used between plant-derived cetylated fatty acids (CFA) and placebo	Baseline (day 0) to days 7, 21, and 42

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-emergent adverse events (AE)	Incidence of post-emergent adverse events (AE)	Baseline (day 0) to day 42
Clinically relevant changes in blood pressure after supplementation	Change in systolic blood pressure (mmHg) after supplementation	Baseline (day 0) to day 42
Clinically relevant changes in heart rate after supplementation	Change in heart rate (beats per minute) after supplementation	Baseline (day 0) to day 42

Collaborators and Investigators

• Sponsor: Everwell Health
• Collaborators: KGK Science Inc.
• Investigators: Principal Investigator: David Crowley, KGK Science Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Knee Pain; Mobility; Stiffness; Joint Health; Cetylated Fatty Acids
• Other Study ID Numbers: 25EHKGC01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No