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Starting soon Not applicable

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

NCT07875101 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2026-10-30
Last updated
2026-10-15

Condition(s) studied

Joint DiscomfortWellbeingQuality of Life

Investigational drug(s) / intervention(s)

Undenatured collagenWhole salmon oil

Undenatured collagen: Natural type II collagen

Whole salmon oil: OmeGo

Study 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

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change in knee pain measured by visual analogue scale (VAS) score — From baseline (day 0) to day 5
    Visual analog scale score of knee pain scored from 0 representing no pain to 100 representing the worst pain imaginable
  • Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) Quality of Life (QoL) score — From baseline (day 0) to end of study (day 30)
    Measure from baseline (day 0) to end of study (day 30). The KOOS QoL score assesses the extent to which knee discomfort is affecting lifestyle and daily enjoyment with 0 representing extreme knee-related QoL problems and 100 representing no knee problems at all. KOOS is designed for assessing milder forms of joint discomfort in active subjects.

Trial sites (1)

FacilityCityRegionStatus
Alethios Inc. San Francisco California

More Hofseth Biocare ASA trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07875101 on ClinicalTrials.gov ↗ ← All trials in the USA