Joint DiscomfortNCT07875101
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
A study testing Undenatured collagen and Whole salmon oil in people with Joint Discomfort and Wellbeing, run by Hofseth Biocare ASA at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Discomfort, Wellbeing, Quality of Life
- What is being tested?
- Undenatured collagen and Whole salmon oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Alethios Inc.
San Francisco, California, 94109
Zoe Benham, MSc, 6502068006, zoe@alethios.com
About this study
Official title: 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
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 .
Read the 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.
- Conditions
- Joint Discomfort, Wellbeing, Quality of Life
- Being tested
- Undenatured collagen, Whole salmon oil
- Keywords
- Joint health, Undenatured type II collagen, Whole salmon oil, Healthy ageing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Undenatured collagenDietary supplement
Natural type II collagen
Whole salmon oilDietary supplement
OmeGo
| Study group | Role | What they receive |
|---|---|---|
| NT-II 480 + OmeGo® | Experimental | Combination arm of undenatured type II collagen and a whole salmon oil Receives: Dietary Supplement: Undenatured collagen; Dietary Supplement: Whole salmon oil |
| UC-II | Active comparator | Chicken sternum undenatured type II collagen Receives: Dietary Supplement: Undenatured collagen |
| NT-II 240 + OmeGo® | Experimental | Combination arm of undenatured type II collagen and a whole salmon oil Receives: Dietary Supplement: Undenatured collagen; Dietary Supplement: Whole salmon oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain measured by visual analogue scale (VAS) score
Visual analog scale score of knee pain scored from 0 representing no pain to 100 representing the worst pain imaginable
Measured: From baseline (day 0) to day 5
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) Quality of Life (QoL) score
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.
Measured: From baseline (day 0) to end of study (day 30)
Secondary outcomes (6)
Change in knee pain measured by visual analogue scale (VAS) score
Visual analog scale score of knee pain scored from 0, representing no pain, and 100, representing the worst pain imaginable.
Measured: Measured from baseline (day 0) to days 10, 20 and 30 (end of study)
Cumulative Change in Knee Pain on visual analogue scale (VAS) scores
Quantify the total change in Cumulative Pain over the intervention period using the weekly participant-reported VAS scores
Measured: Measured from baseline (day 0) to day 30
Cumulative change in knee-related quality of life
The change in knee-related quality of life (KOOS quality of life trajectory) of NT-II® + OmeGo® arm compared to UC-II®
Measured: Mean change from baseline to end of study (with KOOS measured on days 5, 10, 20 and 30)
Overall change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
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.
Measured: From baseline (day 0) to end of study (day 30)
Overall change in the PROMIS Global-10 quality of life score
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 .
Measured: From baseline (day 0) to end of study (day 30)
Change in blood cytokines measured from dry blood spot samples
Pro- and anti-inflammatory cytokines relevant to joint and and overall health
Measured: At baseline (day 0) and at last day of study (day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hofseth Biocare ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875101
- Sponsor's protocol ID
- NT-II-OMEGO-JW-002
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07875101
- Acronym / sponsor ID
- NT-II-OMEGO-JW-002
- Conditions
- Joint Discomfort, Wellbeing, Quality of Life
- Keywords
- Joint health, Undenatured type II collagen, Whole salmon oil, Healthy ageing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hofseth Biocare ASAIndustry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NT-II 480 + OmeGo® | Experimental | Dietary Supplement: Undenatured collagen, Dietary Supplement: Whole salmon oilCombination arm of undenatured type II collagen and a whole salmon oil |
| UC-II | Active comparator | Dietary Supplement: Undenatured collagenChicken sternum undenatured type II collagen |
| NT-II 240 + OmeGo® | Experimental | Dietary Supplement: Undenatured collagen, Dietary Supplement: Whole salmon oilCombination arm of undenatured type II collagen and a whole salmon oil |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Undenatured collagenNatural type II collagen | Dietary supplement | NT-II 240 + OmeGo®, NT-II 480 + OmeGo®, UC-II |
| Whole salmon oilOmeGo | Dietary supplement | NT-II 240 + OmeGo®, NT-II 480 + OmeGo® |
Primary outcome
Change in knee pain measured by visual analogue scale (VAS) score
Time frame: 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
Time frame: 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.
6 secondary outcomes
Change in knee pain measured by visual analogue scale (VAS) score
Time frame: Measured from baseline (day 0) to days 10, 20 and 30 (end of study)
Cumulative Change in Knee Pain on visual analogue scale (VAS) scores
Time frame: Measured from baseline (day 0) to day 30
Cumulative change in knee-related quality of life
Time frame: Mean change from baseline to end of study (with KOOS measured on days 5, 10, 20 and 30)
Overall change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
Time frame: From baseline (day 0) to end of study (day 30)
Overall change in the PROMIS Global-10 quality of life score
Time frame: From baseline (day 0) to end of study (day 30)
Change in blood cytokines measured from dry blood spot samples
Time frame: At baseline (day 0) and at last day of study (day 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Undenatured collagen and Whole salmon oil in people with Joint Discomfort and Wellbeing, run by Hofseth Biocare ASA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee pain measured by visual analogue scale (VAS) score (time frame: From baseline (day 0) to day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.