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
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,
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
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
Parallel
Plant-derived cetylated fatty acids (CFA)
Dietary supplementParticipants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
Placebo
Dietary supplementParticipants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
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
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
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
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
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
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Clinically relevant changes in blood pressure after supplementation
Change in systolic blood pressure (mmHg) after supplementation
Clinically relevant changes in heart rate after supplementation
Change in heart rate (beats per minute) after supplementation
Click on the lead sponsor to view all of their trials.
Everwell Health
Lead sponsor
KGK Science Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
