A Decentralized, Active-Controlled Clinical Trial Investigating the Combination of NT-II® Salmon Bone Undenatured Type II Collagen and OmeGo® Salmon Oil Versus UC-II® Undenatured Chicken Type II Collagen on Knee Pain, Function, and Inflammatory Biomarkers in Adults Who Regularly Suffer From Mild to Moderate Knee Discomfort
Hofseth Biocare ASA
Summary
This study evaluates the combination of NT-II® salmon undenatured type II collagen with OmeGo® salmon oil in adults who regularly experience knee discomfort. The aim is to assess whether participants experience faster and greater improvements in joint health with the combination than undenatured type II collagen alone .
Description
Undenatured type II collagen is well established as a dietary supplement to support joint health. However, it usually takes 3 - 4 weeks to have significant impact, and the level of benefit can vary. Preclinical models have demonstrated the rapid onset of the inflammation-resolving effects of OmeGo®, and clinical trials in healthy adults have demonstrated that OmeGo® is highly bioavailable and helps support a healthier inflammatory profile. This suggests that OmeGo® could provide complementary benefits for better joint health. The co-primary outcomes are knee pain VAS score (0-100 mm) and the…
Eligibility
- Age range
- 40–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Males and females aged 40-75 years * Knee pain which decreases with rest present for at least 3 months prior to screening * Knee pain VAS ≥30 mm and 75 mm in more painful knee at screening (=index knee) * Generally fit and active * BMI 18.5-32.5 kg/m² * Good overall physical and mental health * Ability to provide written informed consent and comply with all study procedures * Access to a smartphone and willingness to use the Alethios digital platform Exclusion Criteria: * Known allergy or hypersensitivity to fish, salmon, or chicken-derived products * Pregnancy, breast…
Interventions
- Dietary SupplementUndenatured collagen
Natural type II collagen
- Dietary SupplementWhole salmon oil
OmeGo
Location
- Alethios Inc.San Francisco, California