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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

2026年8月14日 更新者：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

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • カナダ
    • Ontario
      • London、Ontario、カナダ、N5Y 5V6
        • KGK Science Inc.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
ダイエットサプリメント：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.
プラセボコンパレーター：Placebo
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
ダイエットサプリメント：Placebo
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline to day 42 in knee joint health
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline to days 7 and 21 in knee joint health
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Incidence of post-emergent adverse events (AE)
時間枠：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
時間枠：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
時間枠：Baseline (day 0) to day 42
Change in heart rate (beats per minute) after supplementation
Baseline (day 0) to day 42

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Everwell Health

協力者

KGK Science Inc.

捜査官

  • 主任研究者：David Crowley、KGK Science Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2027年2月1日

研究の完了 (推定)

2027年2月1日

試験登録日

最初に提出

2026年7月6日

QC基準を満たした最初の提出物

2026年7月6日

最初の投稿 (実際)

2026年7月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月18日

QC基準を満たした最後の更新が送信されました

2026年8月14日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 25EHKGC01

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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