NCT05070871

A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women

A Randomized, Double-blind Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Hofseth Biocare ASA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of hydrolyzed collagen in osteoarthritis.

Detailed description

The current study is part of a larger project called the CalGo-project. The overall purpose of the study is to use bone meal from salmon to promote skeletal health. Specifically, the potential for hydrolyzed collagen type II derived from salmon bone meal in ameliorating pain, stiffness and function in participants diagnosed with osteoarthritis will be evaluated over a time period of 6 months. Past literature indicates that collagen derivatives may be a potential supportive strategy in people suffering from osteoarthritis. Osteoarthritis is a common but complex joint disease with significant unmet medical needs, as there are currently no disease-modifying drugs available. Osteoarthritis represents a global health burden and the only curative treatment when pain becomes unmanageable, is joint replacement. The dimensions of pain, stiffness, and function will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC 3.1). Plain x-rays with Kellgren-Lawrence grading will be employed to classify the severity of osteoarthritis. 100 potential participants will be screened for eligibility. Participants who meet the eligibility criteria will be randomized in a double-blind manner to receive 10 capsules daily of hydrolyzed collagen type II (a total of 5000 mg), 10 capsules daily of salmon bone meal, or 10 capsules daily of placebo.

Conditions

• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthritis, Hip

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hydrolyzed Collagen	Hydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.
OTHER	Placebo	Pure maltodextrin.
DIETARY_SUPPLEMENT	CalGo	CalGo is a natural marine collagenic bone powder from salmon. The bone powder is a 100 % microcrystalline hydroxyapatite form of calcium and collagen type 2.

Timeline

• Start date: 2021-09-22
• Primary completion: 2023-12-27
• Completion: 2024-01-15
• First posted: 2021-10-07
• Last updated: 2024-02-13

Locations

3 sites across 1 country: Norway