Actively Recruiting
A Decentralized, Randomized, Active-Controlled Clinical Trial Investigating the Effects of NT-II24 (Salmon Undenatured Type II Collagen) on Activity-Related Knee Discomfort and Functional Performance in Healthy Adults
Led by Hofseth Biocare ASA · Updated on 2026-05-14
120
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating NT-II24, a natural marine supplement derived from salmon undenatured type II collagen, to see if it can reduce knee discomfort caused by physical activity in healthy adults aged 20 to 65. The study compares two doses of NT-II24 (240 mg and 480 mg) to a commonly used joint supplement containing glucosamine and chondroitin. The goal is to understand whether NT-II24 can improve knee comfort, movement, and quality of life better than this active comparator over a 12-week period. Participants are randomly assigned to one of three groups: taking 240 mg of NT-II24 daily, 480 mg of NT-II24 daily, or glucosamine (1500 mg) plus chondroitin (1300 mg) daily. All supplements are taken orally once a day for 12 weeks. The study is conducted entirely remotely, with all materials like supplements, wearable fitness trackers, and blood sample kits sent by mail. No in-person visits are required, and participants use digital tools to report their knee discomfort, complete questionnaires, perform range of motion tests, and track physical activity. During the study, participants report knee pain weekly using a visual analog scale while doing a nominated activity that triggers discomfort, such as climbing stairs or squatting. They complete surveys on joint function, pain, and quality of life, and use a mobile app to measure knee movement. Wearable devices monitor daily activity levels, and blood samples taken at home assess inflammation markers. Researchers will analyze changes in knee discomfort, physical function, quality of life, heart rate variability, and psychological factors related to pain over the 12 weeks.
CONDITIONS
Brief 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
- Knee discomfort occurs at least twice per week during a nominated activity and improves with rest
- Visual analog scale (VAS) pain rating between 30 mm and 75 mm in the past week for the nominated activity
- No diagnosis of structural joint disease such as osteoarthritis
- Engage in physical activity involving knee-loading movements at least twice weekly for 20 or more minutes
- Body Mass Index (BMI) between 20.0 and 32.5 kg/m�b2
- In good general health without significant medical conditions
- Able and willing to provide informed consent
- Capable of completing study procedures remotely using mobile technology
You will not qualify if you...
- Persistent knee pain at rest or recent acute lower-limb injury
- Diagnosed structural or inflammatory joint disorders
- Current or recent physiotherapy for knee pain within the past 6 months
- Allergy to fish or any ingredients of the study products
- Planned lower-limb surgery during the study period
- Other musculoskeletal disorders affecting walking or movement
- Joint injections within the past 3 months
- Use of joint supplements within the past 3 months
- Use of analgesics 3 or more days per week in the past 3 months
- Use of NSAIDs or acetaminophen within 24 hours of 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 the past month
- Use of systemic corticosteroids, immunosuppressants, or opioids within 4 weeks
- Unstable weight or significant recent dietary changes
- Significant medical conditions such as cancer, liver or 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote)
Duration - 1 week
Participants track their knee discomfort symptoms daily without taking any supplement to establish baseline symptom patterns.
Daily symptom tracking remotely
Duration - 12 weeks
Participants take one of three dietary supplements daily for 12 weeks to evaluate effects on activity-related knee discomfort and joint function.
Weekly remote assessments and continuous wearable device monitoring throughout treatment
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
C
Christian Medical Advisor, MD
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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