NT-II™ Collagen for Joint Discomfort and Function
RecruitingNot applicableNCT07119645
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 h…
Study details
- Official title
- A Decentralized, Randomized, Active-Controlled Clinical Trial Investigating the Effects of NT-II™ (Salmon Undenatured Type II Collagen) on Activity-Related Knee Discomfort and Functional Performance in Healthy Adults
- Conditions
- Activity-Related Knee Discomfort
- Joint Discomfort
- Functional Joint Pain
- Functional Knee Pain
- Knee Acute and Chronic Pain
- Interventions
- Dietary supplement: NT-II™ (240 mg)
- Dietary supplement: NT-II™ 480 mg
- Dietary supplement: Glucosamine/Chondroitin
- Sponsor
- Hofseth Biocare ASA
- Start date
- 2025-01-20
- Primary completion
- 2026-07-15
- Sex
- All
- Age range
- from 20 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07119645