Actively Recruiting
NT-II™ Collagen for Joint Discomfort and Function
Led by Hofseth Biocare ASA · Updated on 2026-05-14
120
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
NT-II™ Collagen for Joint Discomfort and Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 to 65 years
- Self-reported reproducible knee discomfort during knee-loading activities for at least 3 months
- Discomfort occurs in at least one knee during a nominated activity at least twice per week and improves with rest
- Pain rating between 30 mm and 75 mm on a visual analog scale during the past week for the nominated activity
- No diagnosis of structural joint disease such as osteoarthritis
- Engages in physical activity involving knee-loading movements at least twice weekly for 20 or more minutes
- Body mass index between 20.0 and 32.5 kg/m
- Generally good health with no significant medical conditions
- Able and willing to provide informed consent
- Able to complete study procedures remotely using mobile technology
You will not qualify if you...
- Persistent knee pain at rest or recent acute lower-limb trauma
- Diagnosed structural or inflammatory joint disorders
- Current or recent physiotherapy for knee pain within past 6 months
- Allergy to fish or any study product ingredients
- Scheduled lower-limb surgery during the study period
- Other musculoskeletal disorders affecting walking
- Joint injections within past 3 months
- Use of joint supplements within past 3 months
- Use of analgesics 3 or more days per week in past 3 months
- NSAIDs or acetaminophen use not allowed within 24 hours before blood sampling or pain assessments
- Chronic use of medications affecting musculoskeletal symptoms unless infrequent and not within 24 hours of assessments
- Regular use of proton pump inhibitors more than 3 times per week in past month
- Use of systemic corticosteroids, immunosuppressants, or opioids within 4 weeks
- Unstable weight or significant recent diet changes
- Significant medical conditions such as cancer, liver/kidney disease, cardiovascular disease, thyroid disease, or 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Alethios Inc.
San Francisco, California, United States, 94109
Actively Recruiting
Research Team
C
Crawford Head of Medical R&D, MD
CONTACT
C
Christian Medical Advisor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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