Joint Discomfort, Wellbeing, Quality of Life
Conditions
Keywords
Joint health, Undenatured type II collagen, Whole salmon oil, Healthy ageing
Brief 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 .
Detailed 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 KOOS Quality of Life (QOL) subscale. Because KOOS embeds the complete WOMAC instrument, WOMAC total and subscale scores are derived directly from the KOOS items and will be reported as secondary outcomes. The KOOS-12 summary score (a 12-item short form joint impact score, also derived from the KOOS items), the remaining KOOS subscales, inflammatory/immune biomarkers via dry blood spot analysis, wearable-derived activity and sleep metrics, and analgesic use are also secondary outcomes.
Interventions
DIETARY_SUPPLEMENTUndenatured collagen
Natural type II collagen
DIETARY_SUPPLEMENTWhole salmon oil
OmeGo
Sponsors
Hofseth Biocare ASA
Alethios, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in knee pain measured by visual analogue scale (VAS) score | Measured from baseline (day 0) to days 10, 20 and 30 (end of study) | Visual analog scale score of knee pain scored from 0, representing no pain, and 100, representing the worst pain imaginable. |
| Cumulative Change in Knee Pain on visual analogue scale (VAS) scores | Measured from baseline (day 0) to day 30 | Quantify the total change in Cumulative Pain over the intervention period using the weekly participant-reported VAS scores |
| Cumulative change in knee-related quality of life | Mean change from baseline to end of study (with KOOS measured on days 5, 10, 20 and 30) | The change in knee-related quality of life (KOOS quality of life trajectory) of NT-II® + OmeGo® arm compared to UC-II® |
| Overall change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score | From baseline (day 0) to end of study (day 30) | Self administered, validated questionnaire comprising 24 items that evaluate knee joint pain, stiffness and physical function, each score 0-4 with the final composite score ranging from 0 to 96 with the higher the score representing the worse the symptoms. |
| Overall change in the PROMIS Global-10 quality of life score | From baseline (day 0) to end of study (day 30) | Measure of overall quality of life measuring physical, mental and social well being utilising 9 questions scored on a 5-point rating scale and 1 question (pain intensity) scored 0-10, converted into a T-score which is calibrated so that a score of 45-54 is average / normal range for the general population, a score of 44 and lower represents a progressively worsening quality of life and a score of 55 and greater represents a progressively improving quality of life . |
| Change in blood cytokines measured from dry blood spot samples | At baseline (day 0) and at last day of study (day 30) | Pro- and anti-inflammatory cytokines relevant to joint and and overall health |
Countries
United States
Outcome results
None listed