Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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 de agosto de 2026 actualizado por: 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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Erin Lewis, PhD
  • Número de teléfono: 248 1-226-242-4551
  • Correo electrónico: elewis@kgkscience.com

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Suplemento dietético: 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.
Comparador de placebos: Placebo
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
Suplemento dietético: Placebo
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline to day 42 in knee joint health
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline to days 7 and 21 in knee joint health
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of post-emergent adverse events (AE)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline (day 0) to day 42
Change in heart rate (beats per minute) after supplementation
Baseline (day 0) to day 42

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Everwell Health

Colaboradores

KGK Science Inc.

Investigadores

  • Investigador principal: David Crowley, KGK Science Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de febrero de 2027

Finalización del estudio (Estimado)

1 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

6 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de julio de 2026

Publicado por primera vez (Actual)

10 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 25EHKGC01

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir