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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-derived cetylated fatty acids (CFA) | Experimental | Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit. |
|
| Placebo | Placebo Comparator | Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-derived cetylated fatty acids (CFA) | Dietary Supplement | Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (day 0) to day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (day 0) to days 7 and 21 |
| Change from baseline to days 7, 21, and 42 in physical functionality and mobility |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Baseline (day 0) to day 42 |
| Clinically relevant changes in blood pressure after supplementation | Change in systolic blood pressure (mmHg) after supplementation |
Inclusion Criteria:
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,
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:
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
A KOOS Pain Subscale score ≥25 and ≤75
Target knee is the primary source of lower-limb pain limiting walking and daily function, as confirmed by the QI
A KOOS Function in daily living (ADL) score ≥25 and ≤ 80
Travel less than 85% of predicted distance on the 6MWT as calculated using the Enright and Sherrill equation at screening (15)
Agrees to refrain from taking any pain relievers during the study, except acetaminophen as a rescue medication specified by the study site
Agrees to refrain from taking rescue medication for 48 hours prior to study visits
Willingness and ability to complete questionnaires, functional tests, records, and diaries associated with the study and to complete all clinic visits
Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history as assessed by the Qualified Investigator (QI)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Lewis, PhD | Contact | 1-226-242-4551 | 248 | elewis@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N5Y 5V6 | Canada |
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| Placebo | Dietary Supplement | Participants will be instructed to take 3-4 softgels daily, starting on day 1 until the day before their end of study visit. |
|
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 | 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 | 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 | 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 |
| Baseline (day 0) to day 42 |
| Clinically relevant changes in heart rate after supplementation | Change in heart rate (beats per minute) after supplementation | Baseline (day 0) to day 42 |