NT-II™ Collagen for Joint Discomfort and Function

NCT07119645 | Not Yet Recruiting

• 1 other identifier: NTII-HBC-001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Activity-Related Knee Discomfort; Joint Discomfort; Functional Joint Pain; Functional Knee Pain; Knee Acute and Chronic Pain

Keywords

Undenatured Type II Collagen; NT-II™; Salmon Collagen; Glucosamine; Chondroitin; Joint Health; Knee Pain; Range of Motion; Activity-Related Pain; Inflammation; Decentralized Clinical Trial; Activity-related Knee Discomfort

Outcome Measures

Primary Outcomes (1)

• Change in participant-nominated activity-related knee discomfort (VASNA for pain) from baseline to week 12

  Each participant will identify a specific weight-bearing activity (e.g., stair descent, walking, or squatting) that consistently causes knee discomfort. Pain intensity will be rated on a 100 mm visual analog scale (VAS) for that activity at baseline and again at week 12. The primary outcome is the change in VASNA score from baseline to week 12.

  Baseline to Week 12

Secondary Outcomes (11)

• Longitudinal Change in Nominated VAS

  Baseline through Week 12.

• Cumulative symptom improvement assessed by Incremental Area Under the Curve (iAUC) of weekly Nominated VAS

  Baseline to Week 12

• KOOS Subscale Changes

  Baseline to Week 6 and Week 12

• KOOS Item-Level Functional Response

  Baseline to Week 6 and Week 12

• SF-12 Health Survey Score Changes

  Baseline to Week 12

Other Outcomes (1)

• Smartwatch-Derived Sleep Quality Score (Exploratory)

  Baseline through weeks 12 (continuous)

Study Arms (3)

NT-II™ 240 mg

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.

Dietary Supplement: NT-II™ (240 mg)

NT-II™ 480 mg

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.

Dietary Supplement: NT-II™ 480 mg

Glucosamine/Chondroitin

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.

Dietary Supplement: Glucosamine/Chondroitin

Interventions

NT-II™ (240 mg) DIETARY_SUPPLEMENT

A once-daily capsule containing 240 mg of NT-II™, a marine-derived undenatured type II collagen supplement obtained from enzymatically processed salmon cartilage and bone. Taken orally for 12 weeks.

NT-II™ 240 mg

NT-II™ 480 mg DIETARY_SUPPLEMENT

Two capsules of NT-II™ (each 240 mg), taken orally once daily for a total of 480 mg/day over 12 weeks. Sourced from salmon bone and cartilage to support joint health via oral tolerance.

NT-II™ 480 mg

Glucosamine/Chondroitin DIETARY_SUPPLEMENT

A combined dietary supplement containing 1500 mg glucosamine and 1300 mg chondroitin, taken orally once daily for 12 weeks. This supplement serves as the active comparator and is widely used to support joint structure and function.

Glucosamine/Chondroitin

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hofseth Biocare ASA: lead

MeSH Terms

Conditions

Chronic Pain; Inflammation

Interventions

Glucosamine; Chondroitin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Glycosaminoglycans; Polysaccharides

Central Study Contacts

Crawford Head of Medical R&D, MD

CONTACT

+44 7968195497; cc@hofsethbiocare.no

Christian Medical Advisor, MD

CONTACT

+47 967 12 226; chbj@hofsethbiocare.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: August 13, 2025
• Study Start: October 19, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share