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Search / Trial NCT07119645

NT-II™ Collagen for Joint Discomfort and Function

Launched by HOFSETH BIOCARE ASA · Aug 5, 2025

Trial Information

Current as of August 20, 2025

Not yet recruiting

Keywords

Undenatured Type Ii Collagen Nt Ii™ Salmon Collagen Glucosamine Chondroitin Joint Health Knee Pain Range Of Motion Activity Related Pain Inflammation Decentralized Clinical Trial Activity Related Knee Discomfort

ClinConnect Summary

This clinical trial is studying whether a natural supplement called NT-II™, made from salmon collagen, can help reduce knee discomfort caused by everyday activities like climbing stairs, walking, or squatting. The study focuses on adults who are generally healthy but experience mild to moderate knee pain during physical activity, even if they don’t have a diagnosed joint disease like arthritis. Researchers want to see if taking NT-II™ once daily for 12 weeks can ease knee pain and improve movement and quality of life better than a common joint supplement containing glucosamine and chondroitin.

If you’re between 20 and 65 years old, physically active at least twice a week, and have had knee discomfort triggered by activity for at least three months, you might be eligible to join. Participants will take their assigned supplement every day and report their knee pain weekly using a simple pain scale while doing an activity that usually causes discomfort. They will also complete short online surveys about joint function and quality of life, use a mobile app to test knee movement, wear a fitness tracker to monitor daily activity, and collect small blood samples at home to check for signs of inflammation. The entire study is done remotely, so there are no clinic visits—everything, including supplements and devices, will be sent by mail, and all data will be submitted through a secure online platform. This approach makes it easier for people to participate from home while helping researchers understand how well NT-II™ supports joint comfort in active adults.

Gender

ALL

Eligibility criteria

  • 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.

About Hofseth Biocare Asa

Hofseth Biocare ASA is a pioneering biotechnology company focused on developing innovative health and wellness solutions derived from marine ingredients. With a commitment to enhancing human health through scientific research and sustainable practices, the company specializes in the extraction and application of bioactive compounds from fish by-products. Hofseth Biocare ASA is dedicated to advancing clinical research initiatives that explore the therapeutic potential of its products, aiming to deliver safe and effective solutions for various health conditions. Through rigorous clinical trials and collaborations with healthcare professionals, the company strives to contribute to the growing field of nutraceuticals and functional foods, promoting overall well-being and improved quality of life.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported