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

NCT ID: NCT05070871

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2024-01-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Hydrolyzed Collagen type II

10 capsules daily of hydrolyzed collagen (CH) type II is taken per orally. Each capsule contains \~500 mg of CH. Once or twice daily dosing. Duration: 6 months.

Group Type: ACTIVE_COMPARATOR

Hydrolyzed Collagen

Intervention Type: DIETARY_SUPPLEMENT

Hydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.

Maltodextrin

10 capsules daily of maltodextrin is taken per orally. Each capsule contains 500 mg of maltodextrin. Once or twice daily dosing. Duration: 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Pure maltodextrin.

Unhydrolyzed Collagen type II (Salmon bone meal)

10 capsules daily of salmon bone meal enriched with vitamin D3 is taken per orally. Each capsule contains 300 mg of maltodextrin, 200 mg of salmon bone meal (10 capsules = 2000 mg salmon bone meal = 340 mg elemental calcium in the form of microcrystalline hydroxyapatite), and 4 micrograms of vitamin D3 (10 capsules = 40 micrograms of vitamin D3 = 1600 IU).

Group Type: EXPERIMENTAL

CalGo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Hydrolyzed Collagen

Hydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Pure maltodextrin.

Intervention Type: OTHER

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Characteristic joint pain indicating osteoarthritis (OA) in the hip(s) or knee(s).
• A radiologically and clinically verified diagnosis of mild to moderate OA graded 1-3 on a Kellgren-Lawrence (KL) grading scale in affected hips or knees.
• Age 18-70 years.
• Familiar with the Norwegian language, both in writing and orally.
• Willingness to participate in the study.

Exclusion Criteria

• A radiologically and clinically verified diagnosis of severe OA graded 4 on a KL grading scale in affected hips or knees.
• Use of drugs (and supplements) known to influence bone and joint metabolism, including Glucocorticoids, > 500 mg daily intake of elemental calcium in medication or supplement form, > 800 IU daily intake of vitamin D3, cancer therapy
• Pregnancy or breastfeeding
• Known fish allergy and history of hypersensitivity to any of the components in the interventional product.
• Other reasons which the principal investigator deems it necessary to exclude a potential participant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Møre og Romsdal Hospital Trust

OTHER

Sponsor Role: collaborator

Hofseth Biocare ASA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Øystein Bjerkestrand Lian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital

Locations

Hofseth Biocare ASA

Ålesund, Møre og Romsdal, Norway

Kristiansund Hospital

Kristiansund, Møre og Romsdal, Norway

Lovisenberg Diakonale Sykehus

Oslo, , Norway

Countries

Norway

Other Identifiers

CALGO-ART

Identifier Type: -

Identifier Source: org_study_id