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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
Participants will be instructed to take 4 softgels daily, starting on day 1 until the day before their end of study visit.
KGK Science Inc.
London, Ontario, Canada
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
Time frame: Baseline (day 0) to day 42
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
Time frame: Baseline (day 0) to days 7 and 21
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
Time frame: Baseline (day 0) to days 7, 21, and 42
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
Time frame: Baseline (day 0) to days 7, 21, and 42
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
Time frame: Baseline (day 0) to days 7, 21, and 42
Rescue medication
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
Time frame: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related symptoms
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
Time frame: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in activities of daily living
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
Time frame: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in sport and recreation function
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
Time frame: Baseline (day 0) to days 7, 21, and 42
Change from baseline to days 7, 21, and 42 in knee-related quality of life
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
Time frame: Baseline (day 0) to days 7, 21, and 42
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