Hydrolyzed collagen
Dietary SupplementHydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.
NCT Number: NCT05070871
The purpose of this study is to evaluate the efficacy of hydrolyzed collagen in osteoarthritis.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Kristiansund Hospital, Kristiansund, Møre og Romsdal, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.
Pure maltodextrin.
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.
Time frame: Baseline, 3 Months, and 6 Months
A change in osteoarthritis symptomatology is assessed using a disease specific questionnaire (WOMAC 3.1).
Time frame: Baseline, 3 Months, and 6 Months
Pain is evaluated using the pain dimension of WOMAC 3.1, a disease-specific questionnaire. The pain subscale includes 5 items that assesses pain intensity. A score is produced when the value of each item is summarized. A higher score indicates worse pain.
Time frame: Baseline, 3 Months, and 6 Months
A GAS scale gives an overall picture of an individuals' self-assessed effect of treatment. The individual is asked to compare the present health status with their health status at a previous point in time. The magnitude of this difference is scored numerically. In this study, we will use GAS on a 11-point Likert rating scale ranging from "completely recovered" to "worse than ever", with 0 being "unchanged" status.
Time frame: Baseline, 3 Months, and 6 Months
In this study, we will employ an 11-point (i.e., 0 to 10) Numerical Rating Scale as was recommended for use in chronic pain trials according to 2005 IMMPACT guidelines. 0 represents "No pain", and 10 represents "The most intense pain imaginable".
Time frame: Baseline, 6 Months
Rescue medications that participants may use on an as needed basis include Paracetamol, typical NSAIDs, and analgesics containing opioids.
Time frame: Baseline, 3 Months, and 6 Months
EQ-5D-3L is a standardized instrument used to measure generic quality of life based on five distinct dimensions. EQ-5D-3L contains two parts. The first part contains five questions that the individual must answer and includes mobility (walking), self-care, usual activities, pain/discomfort, and anxiety/depression. For each item, there are three possible answers. Results are reported as a five-digit number ranging from 11111 (best health status) to 33333 (worst health status).
Time frame: 3 Months, and 6 Months.
Reported between the hydrolyzed collagen group and placebo group, and the CalGo group and placebo group.
Hofseth Biocare ASA
Industry
A Randomized, Double-blind Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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