Recruiting soon

NTII-JOINTMarine Collagen for Activity-Related Knee Discomfort in Healthy Adults

What is being tested

NT-II™ (240 mg)

+ NT-II™ 480 mg

+ Glucosamine/Chondroitin

Dietary Supplement

Who is being recruted

Inflammation+4

+ Neurologic Manifestations

+ Pain

From 20 to 65 Years

+35 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: October 2025

See protocol details

Summary

Principal SponsorHofseth Biocare ASA

Study ContactCrawford Head of Medical R&D, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 19, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on understanding how NT-II™, a special type of collagen derived from Norwegian Atlantic salmon, can help reduce knee discomfort caused by activities like climbing stairs or squatting in otherwise healthy adults. The study involves people aged 20 to 65 who have been experiencing this type of knee pain for at least three months. This research is important because finding effective, non-drug solutions for managing knee pain can greatly improve comfort and quality of life for many individuals. Unlike other collagen products made from chicken, NT-II™ offers a novel alternative, and this study will help determine its effectiveness and potential benefits compared to glucosamine and chondroitin. Participants in the study will be randomly assigned to one of three groups, each receiving a different treatment for 12 weeks: a standard dose of NT-II™, a high dose of NT-II™, or a combination of glucosamine and chondroitin. The main goal is to measure changes in knee pain using a special scale that participants fill out weekly to track their discomfort. In addition to pain levels, the study will also look at knee movement, quality of life, daily activity levels, and various health markers using digital tools and at-home tests. This trial uses a decentralized approach, meaning everything from data collection to treatment administration happens remotely, leveraging technology to make participation easier and more flexible.

Official TitleA 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

NCT07119645

Principal SponsorHofseth Biocare ASA

Study ContactCrawford Head of Medical R&D, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InflammationNeurologic ManifestationsPainPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsChronic Pain

Criteria

10 inclusion criteria required to participate

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.

Show More Criteria

25 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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 II

Experimental

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 III

Active Comparator

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers