This randomised study evaluates the efficacy of an oral dietary supplement of Hydrolyzed Collagen in reducing pain and improving physical function in subjects with osteoarthritis.
In recent years, research efforts have focused on interventions such as collagen supplementation as an alternative treatment for pain and physical function in patients with osteoarthritis. Hydrolyzed collagen (HC) is a mixture of collagen peptides with a molecular weight of less than 5,000 Da. It is obtained from the gelatinization and subsequent enzymatic hydrolysis of native collagen from animal tissues rich in this protein. In this line, several studies show that HC is more easily absorbed enzymatically, has a higher bioavailability, is distributed to joint tissues, and has analgesic and anti-inflammatory properties, consistently showing symptom-relieving effects, thus improving joint function and reducing joint pain, as well as optimizing the patient's quality of life. In this randomized pilot study, the investigators aimed to evaluate the effect on pain and other parameters related to physical function of an oral dietary HC supplement composed of lemon flavoring, anhydrous citric acid (acidifier), calcium ascorbate (vitamin C), sucralose (sweetener) and stevia (sweetener). A 10.728 g dose provides 10 g of HC and 80 mg of vitamin C. Each placebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation. Both the active and the placebo were manufactured by NutraResearch© SL (Barcelona, Spain) under Good Manufacturing Practices (GMPs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Active product was composed of Hydrolyzed Collagen, lemon flavoring, anhydrous citric acid (acidifier), calcium ascorbate (vitamin C), sucralose (sweetener) and stevia (sweetener). One 10.728 g dose provides 10 g of HC and 80 mg of vitamin C.
Placebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation.
NutraResearch, SL
Barcelona, Spain
Change in baseline osteoarticular pain at 6 months
Pain level, assessed by Visual Analogue Scale through a repeated measures analysis at two time points (baseline and end of intervention).
Time frame: 0 and 6 months
Change in baseline functional limitation at 6 months
Functional limitation, assessed by Lesquene Algofunctional Index through a repeated measures analysis at two time points (baseline and end of intervention)
Time frame: 0 and 6 months
Change in C-reactive protein (CRP)
Fasting serum levels of C-reactive protein (CRP), assessed by repeated measures analysis at two timepoints ((baseline and end of intervention).
Time frame: 0 and 6 months
Change in erythrocyte sedimentation rate (ESR)
Fasting serum levels of erythrocyte sedimentation rate (ESR), assessed by repeated measures analysis at two timepoints ((baseline and end of intervention).
Time frame: 0 and 6 months
Patient satisfaction with treatment
Rated with a 3 categories (Good, Poor, Fair), assessed at the end of the intervention.
Time frame: 6 months
Treatment-emergent adverse effects
Incidence of adverse effects (type and number) and relatedness to study product (using a 5 category system: certain, likely related, possibly related, conditionally related, unknown), as documented according to the Spanish Medicine and Medical Device Agency (AEMPS) pharmacovigilance system.
Time frame: 6 months
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