Joint HealthNCT07695714
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 study testing Plant-derived cetylated fatty acids (CFA) in people with Joint Health and Mobility, run by Everwell Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Health, Mobility, Knee Pain
- What is being tested?
- Plant-derived cetylated fatty acids (CFA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
- Agrees to refrain from taking rescue medication for 48 hours prior to study visits
- Willingness and ability to complete questionnaires, functional tests, records, and diaries associated with the study and to complete all clinic visits
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history as assessed by the Qualified Investigator (QI)
Who cannot join
- 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
Show all 30Show fewer
- 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
- 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
- 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
- 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
- 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
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Use of prescription medical cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- 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
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- 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
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Joint Health, Mobility, Knee Pain
- Being tested
- Plant-derived cetylated fatty acids (CFA), Placebo
- Keywords
- Joint Health, Mobility, Knee Pain, Stiffness, Cetylated Fatty Acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-derived cetylated fatty acids (CFA)Dietary supplement
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
PlaceboDietary supplement
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
| Study group | Role | What they receive |
|---|---|---|
| Plant-derived cetylated fatty acids (CFA) | Experimental | Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit. Receives: Dietary Supplement: Plant-derived cetylated fatty acids (CFA) |
| Placebo | Placebo comparator | Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (day 0) to day 42
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related symptoms
Change from baseline to days 7, 21, and 42 in knee-related symptoms, as assessed by the corresponding Knee injury and Osteoarthritis Outcome Score (KOOS) subscale scores, between plant-derived cetylated fatty acids (CFA) and placebo. The Symptoms subscale comprises 7 items, each scored from 0 to 4, giving a raw score range of 0-28. The raw score may be transformed to a 0-100 scale, where higher scores indicate a better outcome.
Measured: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in activities of daily living
Change from baseline to days 7, 21, and 42 in activities of daily living, as assessed by the corresponding Knee injury and Osteoarthritis Outcome Score (KOOS) subscale scores, between plant-derived cetylated fatty acids (CFA) and placebo. The function in daily living subscale comprises 17 items, with each item scored from 0 to 4, giving a raw score range of 0 to 68. The raw score may be transformed to a 0-100 scale, where higher scores indicate a better outcome.
Measured: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in sport and recreation function
Change from baseline to days 7, 21, and 42 in sport and recreation function, as assessed by the corresponding Knee injury and Osteoarthritis Outcome Score (KOOS) subscale scores, between plant-derived cetylated fatty acids (CFA) and placebo. The sport and recreation subscale comprises 5 items, with each item scored from 0 to 4, giving a raw score range of 0 to 20. The raw score may be transformed to a 0-100 scale, where higher scores indicate a better outcome.
Measured: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related quality of life
Change from baseline to days 7, 21, and 42 in knee-related quality of life, as assessed by the corresponding Knee injury and Osteoarthritis Outcome Score (KOOS) subscale scores, between plant-derived cetylated fatty acids (CFA) and placebo. The subscale comprises 4 items, with each item scored from 0 to 4, giving a raw score range of 0 to 16. The raw score may be transformed to a 0-100 scale, where higher scores indicate a better outcome.
Measured: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related symptoms
Change from baseline to days 7, 21, and 42 in knee-related symptoms, activities of daily living, sport and recreation function, and knee-related quality of life, as assessed by the corresponding Knee injury and Osteoarthritis Outcome Score (KOOS) subscale scores, between plant-derived cetylated fatty acids (CFA) and placebo. The raw scores may be transformed to a 0-100 scale, where higher scores indicate a better outcome.
Measured: Baseline (day 0) to days 7, 21, and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Everwell Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695714
- Sponsor's protocol ID
- 25EHKGC01
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07695714
- Acronym / sponsor ID
- 25EHKGC01
- Conditions
- Joint Health, Mobility, Knee Pain
- Keywords
- Joint Health, Mobility, Knee Pain, Stiffness, Cetylated Fatty Acids
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Everwell HealthIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant-derived cetylated fatty acids (CFA) | Experimental | Dietary Supplement: Plant-derived cetylated fatty acids (CFA)Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-derived cetylated fatty acids (CFA)Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit. | Dietary supplement | Plant-derived cetylated fatty acids (CFA) |
| PlaceboParticipants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit. | Dietary supplement | Placebo |
Primary outcome
Change from baseline to day 42 in knee joint health
Time frame: Baseline (day 0) to day 42
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
10 secondary outcomes
Change from baseline to days 7 and 21 in knee joint health
Time frame: Baseline (day 0) to days 7 and 21
Change from baseline to days 7, 21, and 42 in physical functionality and mobility
Time frame: Baseline (day 0) to days 7, 21, and 42
30 seconds chair sit to stand test
Time frame: Baseline (day 0) to days 7, 21, and 42
Joint pain/stiffness following mobility challenge
Time frame: Baseline (day 0) to days 7, 21, and 42
Rescue medication
Time frame: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related symptoms
Time frame: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in activities of daily living
Time frame: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in sport and recreation function
Time frame: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related quality of life
Time frame: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related symptoms
Time frame: Baseline (day 0) to days 7, 21, and 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-derived cetylated fatty acids (CFA) in people with Joint Health and Mobility, run by Everwell Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewis, PhD (1-226-242-4551 ext. 248, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to day 42 in knee joint health (time frame: Baseline (day 0) to day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.