NT-II™ Collagen for Knee Pain

(NTII-JOINT Trial)

Overseen By Crawford Head of Medical R&D, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hofseth Biocare ASA

Must not be taking: NSAIDs, Opioids, Corticosteroids, others

Disqualifiers: Osteoarthritis, Recent knee injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a natural marine supplement called NT-II™ Collagen can ease knee pain from activities like climbing stairs or squatting. Researchers seek to compare the effectiveness of NT-II™ Collagen in reducing knee discomfort against a common joint supplement made of glucosamine and chondroitin. Participants will take one of these supplements daily for 12 weeks and report on their knee pain and movement quality. Eligible participants are U.S.-based adults in good health who have experienced mild to moderate knee pain during activities for at least three months, without any diagnosed joint diseases. The study is conducted entirely online, eliminating the need for clinic visits. As an unphased trial, this study provides a unique opportunity to contribute to research on natural supplements for knee pain relief.

Do I have to stop taking my current medications for the trial?

Participants should not use NSAIDs, turmeric, collagen, or other joint-related supplements during the study. Some medications like NSAIDs and acetaminophen are allowed with restrictions, such as not using them within 24 hours of certain assessments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NT-II™, a type of undenatured collagen from salmon, is generally safe for people. Studies have found no negative side effects in those using this collagen, suggesting it is safe to consume. Specifically, one study found that small amounts of this collagen can help reduce inflammation in the body, supporting joint health without causing harm.

The other treatment in the trial is a mix of glucosamine and chondroitin, which are already widely used and considered safe. These supplements are commonly available and have supported joint health in many people. Both treatments appear to be safe options for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about NT-II™ collagen because it offers a fresh approach to managing knee pain. Unlike standard treatments like glucosamine and chondroitin, NT-II™ is derived from salmon cartilage and bone, bringing a marine-based, undenatured type II collagen into the mix. This new treatment is thought to work through a mechanism called oral tolerance, which might help the body naturally support joint health. With two different dosages being tested, 240 mg and 480 mg, there's potential for a more tailored approach to improving joint comfort and mobility.

What evidence suggests that NT-II™ Collagen could be an effective treatment for knee pain?

Studies have shown that undenatured type II collagen, such as NT-II™, can reduce joint pain and improve mobility. Past research found this collagen effective in easing symptoms for individuals with joint issues, including knee pain. It helps control inflammation, reducing discomfort and facilitating easier movement. Research indicates that those taking type II collagen reported less pain and stiffness compared to those not taking it. In this trial, participants will receive either NT-II™ at doses of 240 mg or 480 mg, or a comparator treatment of Glucosamine/Chondroitin. Overall, NT-II™ shows promising potential for relieving knee discomfort from physical activity. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for U.S. adults aged 20-65 who are generally healthy but have had mild to moderate knee pain from activities like walking or climbing stairs for at least 3 months. Participants must not have arthritis, recent knee injuries, major surgeries, or use joint supplements or NSAIDs during the study.

Inclusion Criteria

I am willing and able to agree to participate in the study.

I am able to use a mobile device to complete study tasks remotely.

I am between 20 and 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Run-in

Participants track symptoms without intervention to establish baseline data

1 week

Treatment

Participants take their assigned supplement daily and track knee discomfort weekly using a visual analog scale (VAS) for 12 weeks

12 weeks

Remote monitoring and weekly self-assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NT-II™ Collagen

Trial Overview

The study compares two daily doses of NT-II™ (a salmon collagen supplement) with a standard glucosamine/chondroitin supplement over 12 weeks to see which works better at reducing activity-related knee discomfort and improving movement in active adults.

How Is the Trial Designed?

Group I: NT-II™ 480 mg Experimental Treatment 1 Intervention

Participants in this arm will take two capsules of NT-II™ (each containing 240 mg) by mouth daily for a total daily dose of 480 mg for 12 weeks. The product is a marine-based undenatured type II collagen intended to support joint comfort and mobility.

Group II: NT-II™ 240 mg Experimental Treatment 1 Intervention

Participants in this arm will take one capsule of NT-II™ (Salmon Undenatured Type II Collagen) containing 240 mg daily by mouth for 12 weeks. The product is derived from enzymatically processed salmon cartilage and bone, designed to support joint health through oral tolerance mechanisms.

Group III: Glucosamine/Chondroitin Active Control 1 Intervention

Participants in this arm will take a commercially available joint supplement (Kirkland) containing 1500 mg glucosamine and 1300 mg chondroitin by mouth daily for 12 weeks. This combination is commonly used to support joint structure and function and serves as the comparator in this study.

Who Is Running the Clinical Trial?

Hofseth Biocare ASA

Lead Sponsor

Trials

8

Recruited

610+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4970562/

Effects of Native Type II Collagen Treatment on Knee ... - PMC

Native type II collagen has been found to be effective in reducing arthritic pain in animal models [10–12] as well as in improving clinical outcomes in ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7222752/

Undenatured Type II Collagen (UC-II) in Joint Health ... - PMC

UC-II improved knee joint symptoms in knee OA subjects and was well-tolerated. No Adverse events, [76]. 13, Assessing the UC-II to prevention against the ...

3.

link.springer.com

link.springer.com/article/10.1186/s12937-026-01302-0

Efficacy and tolerability of native (undenatured) type II ...

Supplementation with native (undenatured) type-II collagen has been shown to help to control inflammation at the joint level through an immune- ...

4.

biomedres.us

biomedres.us/fulltexts/BJSTR.MS.ID.009755.php

NT-II™ Undenatured Type II Collagen: Comprehensive In ...

Native type II collagen has shown therapeutic potential for rheumatoid arthritis and osteoarthritis, though most studies have focused on ...

5.

cochranelibrary.com

cochranelibrary.com/es/content?templateType=related&urlTitle=%2Fcentral%2Fdoi%2F10.1002%2Fcentral%2FCN-01924472&doi=10.1002%2Fcentral%2FCN-01924472&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Undenatured type II collagen (UC-II) for joint support

Undenatured type II collagen (UC-II) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers.

6.

researchgate.net

researchgate.net/publication/393596195_NT-II_Undenatured_Type_II_Collagen_Comprehensive_In_Vitro_Characterization_of_Bioaccessibility_Epitope_Integrity_and_Collagen_Typing

(PDF) NT-II™ Undenatured Type II Collagen

NT-II™ Undenatured Type II Collagen: Comprehensive In Vitro Characterization of Bioaccessibility, Epitope Integrity, and Collagen Typing.