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

NCT07695714 | Not Yet Recruiting

• 1 other identifier: 25EHKGC01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Joint Health; Mobility; Knee Pain

Keywords

Joint Health; Mobility; Knee Pain; Stiffness; Cetylated Fatty Acids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline to days 7 and 21 in knee joint health

  Baseline (day 0) to days 7 and 21

• Change from baseline to days 7, 21, and 42 in physical functionality and mobility

  Baseline (day 0) to days 7, 21, and 42

• 30 seconds chair sit to stand test

  Baseline (day 0) to days 7, 21, and 42

• Joint pain/stiffness following mobility challenge

  Baseline (day 0) to days 7, 21, and 42

• Rescue medication

  Baseline (day 0) to days 7, 21, and 42

Other Outcomes (3)

• Incidence of post-emergent adverse events (AE)

  Baseline (day 0) to day 42

• Clinically relevant changes in blood pressure after supplementation

  Baseline (day 0) to day 42

• Clinically relevant changes in heart rate after supplementation

  Baseline (day 0) to day 42

Study Arms (2)

Plant-derived cetylated fatty acids (CFA)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

Plant-derived cetylated fatty acids (CFA) DIETARY_SUPPLEMENT

Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit.

Plant-derived cetylated fatty acids (CFA)

Placebo DIETARY_SUPPLEMENT

Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit.

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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
• 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
• 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

You may not qualify if:

• 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
• 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
• History of knee replacement
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Type I or Type II and controlled Type II diabetes
• 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

Sponsors & Collaborators

• Everwell Health: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N5Y 5V6, Canada

Location

Study Officials

• David Crowley

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Lewis, PhD

CONTACT

1-226-242-4551; elewis@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

CA (1)