NCT07119645 · Hofseth Biocare ASA
NT-II™ Collagen for Joint Discomfort and Function
(NTII-JOINT)
What this study is about
The goal of this clinical trial is to learn whether a natural marine supplement called NT-II™ (Salmon Undenatured Type II Collagen) can help lower knee discomfort caused by physical activity in otherwise healthy adults.
View original scientific description
The goal of this clinical trial is to learn whether a natural marine supplement called NT-II™ (Salmon Undenatured Type II Collagen) can help lower knee discomfort caused by physical activity in otherwise healthy adults. Many active people experience knee pain when performing daily movements like climbing stairs, walking long distances, or squatting, even if they do not have a medical diagnosis such as arthritis. This discomfort can limit mobility, impact exercise routines, and reduce overall quality of life. This study is being conducted to determine whether NT-II™, taken as a once-daily oral supplement, can reduce this type of activity-related knee discomfort more effectively than a commonly used joint supplement containing glucosamine and chondroitin. The main questions the study aims to answer are: Does NT-II™ reduce knee discomfort caused by repeated activity over a 12-week period? Does NT-II™ improve movement and quality of life compared to glucosamine-chondroitin? Researchers will compare two different doses of NT-II™ (240 mg and 480 mg) to glucosamine (1500 mg) plus chondroitin (1300 mg), which is used as an active comparator. All three products will be taken once daily for 12 weeks. Participants will: Take their assigned supplement daily by mouth for 12 weeks Track knee discomfort once per week using a pain rating scale called a visual analog scale (VAS) while doing an activity that usually causes discomfort, such as climbing stairs, walking, or squatting Complete short surveys online about joint function, pain, and quality of life (including KOOS and SF-12 questionnaires) Use a mobile app to perform simple knee range of motion tests at home Wear a fitness tracker to monitor daily physical activity, such as step count and stair climbing Collect two small blood samples at home using a finger-prick kit to check for changes in inflammation-related biomarkers This study is for U.S.-based adults between the ages of 20 and 65 who are in generally good health but have had mild to moderate knee discomfort caused by physical activity for at least three months. The pain must be triggered by specific weight-bearing movements and be relieved by rest. Participants must not have osteoarthritis, rheumatoid arthritis, or other joint diseases. Individuals with recent knee injuries, major surgeries, or injections in the past six months cannot take part. Participants should not be using NSAIDs, turmeric, collagen, or other joint-related supplements during the study. All study activities will take place remotely using a secure digital platform. There are no in-person clinic visits required. Eligible participants will receive all study materials by mail, including supplements, a wearable device, and an at-home blood sample collection kit. They will also be given access to a secure digital platform (Alethios) where they can complete questionnaires, enter pain ratings, and receive study instructions. Study staff will monitor progress, check for missing data, and assist participants through secure communication tools built into the platform. The primary outcome of the study is the change in participant-reported knee discomfort, measured using a nominated activity VAS score (VASNA), from baseline to week 12. Additional outcomes will explore changes in function, mobility, physical activity, heart rate variability, and inflammatory biomarkers. The Pain Catastrophizing Scale (PCS) will also be used to examine whether thoughts and feelings about pain influence symptom reporting and treatment response. This trial is sponsored by Hofseth BioCare ASA and is being conducted entirely online to improve access, lower participant burden, and support real-world understanding of joint health supplements. Study results may inform the use of NT-II™ as a marine-based nutritional strategy to support joint comfort in active individuals.
Interventions
DIETARY_SUPPLEMENT
NT-II™ (240 mg)
A once-daily capsule containing 240 mg of NT-II™, a marine-derived undenatured type II collagen supplement obtained from enzymatically processed salmon cartilage and bone. Taken orally for 12 weeks.
DIETARY_SUPPLEMENT
NT-II™ 480 mg
Two capsules of NT-II™ (each 240 mg), taken orally once daily for a total of 480 mg/day over 12 weeks. Sourced from salmon bone and cartilage to support joint health via oral tolerance.
DIETARY_SUPPLEMENT
Glucosamine/Chondroitin
A combined dietary supplement containing 1500 mg glucosamine and 1300 mg chondroitin, taken orally once daily for 12 weeks. This supplement serves as the active comparator and is widely used to support joint structure and function.
Primary outcome measures
Change in participant-nominated activity-related knee discomfort (VASNA for pain) from baseline to week 12
Time frame: Baseline to Week 12
Each participant will identify a specific weight-bearing activity (e.g., stair descent, walking, or squatting) that consistently causes knee discomfort. Pain intensity will be rated on a 100 mm visual analog scale (VAS) for that activity at baseline and again at week 12. The primary outcome is the change in VASNA score from baseline to week 12.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults aged 20 to 65 years.
- Self-reported, reproducible knee discomfort associated with any knee-loading activities for at least 3 months prior to screening.
- Discomfort must occur in at least one knee during a nominated aggravating activity at least twice per week and subside with rest.
- VAS rating of 30 mm to 75 mm during the past week for the nominated activity.
- No current diagnosis of structural joint disease (e.g., osteoarthritis).
- Engages in physical activity involving knee-loading movements at least twice weekly for 20+ minutes.
- BMI between 20.0 and 32.5 kg/m².
- In good general health with no significant medical comorbidities.
- Able and willing to provide informed consent.
- Capable of completing study procedures remotely using mobile technology.
Exclusion criteria
- Persistent knee pain at rest or recent acute lower-limb trauma.
- Diagnosed structural or inflammatory joint disorders.
- Current or recent physiotherapy targeting knee pain (within 6 months).
- Allergy to fish or any study product ingredients.
- Scheduled lower-limb surgery during the study period.
- Other musculoskeletal disorders affecting ambulation.
- Recent joint injections (within 3 months).
- Use of joint supplements in the past 3 months.
- Use of analgesics ≥3 days/week in the past 3 months.
- NSAIDs/acetaminophen use is permitted with restrictions:
- Not within 24 hours of blood sampling or VAS assessments.
- Must be documented.
- Chronic use of medications that affect musculoskeletal symptoms (e.g., muscle relaxants, gabapentinoids) unless infrequent (≤2x/week) and not within 24 hours of assessments.
- Regular use of PPIs (\>3x/week in past month).
- Systemic corticosteroids, immunosuppressants, or opioids within 4 weeks.
- Unstable weight or significant recent dietary changes.
- Significant medical conditions (e.g., cancer, hepatic/renal impairment, CVD, thyroid disease, diabetes).
- Neurological, cognitive, or psychiatric disorders affecting participation.
- Use of tobacco/nicotine or other substances.
- Diagnosed sleep disorders.
- Strict vegan diet or sedentary lifestyle.
- Inability to swallow capsules.
- Pregnant, breastfeeding, or planning pregnancy.
- Women of childbearing potential not using contraception.
- Participation in another interventional clinical trial.
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations