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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

2026년 8월 14일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

80

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
건강 보조 식품: 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.
위약 비교기: Placebo
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
건강 보조 식품: Placebo
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline to day 42 in knee joint health
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline to days 7 and 21 in knee joint health
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Incidence of post-emergent adverse events (AE)
기간: 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
기간: 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
기간: Baseline (day 0) to day 42
Change in heart rate (beats per minute) after supplementation
Baseline (day 0) to day 42

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Everwell Health

협력자

KGK Science Inc.

수사관

  • 수석 연구원: David Crowley, KGK Science Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2026년 7월 6일

QC 기준을 충족하는 최초 제출

2026년 7월 6일

처음 게시됨 (실제)

2026년 7월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 14일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 25EHKGC01

약물 및 장치 정보, 연구 문서

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아니

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