A Clinical Trial to Investigate the Efficacy and Safety of a Plant-based 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-based Cetylated Fatty Acids 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

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