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NCT07875101
Assessing the Potential for Improved Joint Health and Wellbeing by Providing a Whole Salmon Oil With Undenatured Type II Collagen Compared to Type II Collagen Alone
Conditions: Joint Discomfort, Wellbeing, Quality of Life
Sex: All
Ages: 40 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 150
Sponsor: Hofseth Biocare ASA
Location: Alethios Inc. San Francisco California
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 .
Eligibility Criteria
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, breastfeeding, or planned pregnancy during the study period
* Secondary OA (e.g., post-traumatic, inflammatory arthritis, rheumatoid arthritis)
* Planned or prior knee surgery within 6 months of study entry
* Intra-articular injections (corticosteroid or hyaluronic acid) within 3 months of Day 0
* Chronic back, hip or foot pain affecting ambulation
* Systemic corticosteroid therapy within 4 weeks of Day 0
* Use of opioid-based treatments for pain relief
* Continuous use of any analgesia including acetaminophen and NSAIDs
* Active bleeding disorders or use of anticoagulant therapy (warfarin, novel oral anticoagulants)
* Participation in another clinical trial within 30 days of Day 0
* Use of joint supplements - glucosamine, chondroitin, collagen supplements, boswellia, curcumin or omega-3 supplements within 4 weeks of Day 0 (washout required)
* Regular use of proton pump inhibitors (e.g. omeprazole, esomeprazole etc) of ≥3 times per week within the past month
* Unstable weight (±5 kg in past 3 months) or significant dietary changes
* Any significant systemic disease that, in the investigator's judgment, would interfere with study participation or safety
* Inability or unwillingness to comply with study procedures
Source: ClinicalTrials.gov (NCT07875101). StuddyBuddy aggregates publicly available trial information.