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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

14 août 2026 mis à jour par: Everwell Health

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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Complément alimentaire: 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.
Comparateur placebo: Placebo
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
Complément alimentaire: Placebo
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline to day 42 in knee joint health
Délai: 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
Baseline (day 0) to day 42

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline to days 7 and 21 in knee joint health
Délai: Baseline (day 0) to days 7 and 21
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
Délai: Baseline (day 0) to days 7, 21, and 42
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
Délai: Baseline (day 0) to days 7, 21, and 42
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
Délai: Baseline (day 0) to days 7, 21, and 42
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
Délai: Baseline (day 0) to days 7, 21, and 42
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
Change from baseline to days 7, 21, and 42 in knee-related symptoms
Délai: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related symptoms, as assessed by the corresponding KOOS subscale scores, between plant-derived cetylated fatty acids (CFA) and placebo
Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in activities of daily living
Délai: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in activities of daily living, as assessed by the corresponding KOOS subscale scores, between plant-derived cetylated fatty acids (CFA) and placebo
Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in sport and recreation function
Délai: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in sport and recreation function, as assessed by the corresponding KOOS subscale scores, between plant-derived cetylated fatty acids (CFA) and placebo
Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related quality of life
Délai: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related quality of life, as assessed by the corresponding KOOS subscale scores, between plant-derived cetylated fatty acids (CFA) and placebo
Baseline (day 0) to days 7, 21, and 42

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Incidence of post-emergent adverse events (AE)
Délai: Baseline (day 0) to day 42
Incidence of post-emergent adverse events (AE)
Baseline (day 0) to day 42
Clinically relevant changes in blood pressure after supplementation
Délai: Baseline (day 0) to day 42
Change in systolic blood pressure (mmHg) after supplementation
Baseline (day 0) to day 42
Clinically relevant changes in heart rate after supplementation
Délai: Baseline (day 0) to day 42
Change in heart rate (beats per minute) after supplementation
Baseline (day 0) to day 42

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Everwell Health

Collaborateurs

KGK Science Inc.

Les enquêteurs

  • Chercheur principal: David Crowley, KGK Science Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 février 2027

Achèvement de l'étude (Estimé)

1 février 2027

Dates d'inscription aux études

Première soumission

6 juillet 2026

Première soumission répondant aux critères de contrôle qualité

6 juillet 2026

Première publication (Réel)

10 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 25EHKGC01

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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