Effect Size Statistics to Inform an Exploratory Analysis of a Double-Blinded, Randomised, Placebo Controlled Pilot Clinical Study to Evaluate the Efficacy of Naticol®, Specific Fish Collagen Peptides to Alleviate Symptoms of Osteoarthritis in the Knee
Potential effects of different doses of specific fish collagen peptides (Naticol®) on the signs of skin ageing were firstly assessed in double-blind, randomised and placebo controlled clinical studies. The studies showed benefits of fish collagen peptides (Naticol®) on skin firmness, skin hydration and wrinkle appearance. In addition to these benefits, some animal experiments have suggested that ingestion of specific fish collagen peptides (Naticol®) might also have beneficial effects on joint health such as osteoarthritis. This pilot clinical trial study was designed to assess the safety and tolerability of daily oral doses of specific fish collagen peptides (Naticol®) in healthy subjects with knee osteoarthritis. In a double-blinded, placebo controlled pilot clinical study, 30 adults (20 active; 10 placebo) consumed a 10g sachet of the investigational product (Naticol®; specific fish collagen peptides) and a comparator product (maltodextrin) daily in 20cl of cold liquid (fruit juice, milk or cold tea) 15 minutes before breakfast, for 8 weeks. Potential pain reduction was tested using the Western Ontario McMaster Universities (WOMAC) scores; Quality of Life (QOL) using the Participant Global Assessment (SF-36v2 questionnaire) and Physical performance using the Short Physical Performance Battery (SPPB) at both baseline and after 8 weeks.
From effect size statistics (Cohen’s d), subjects in the active group experienced more of an improvement across the majority of measurements than subjects in the placebo group over the 8 weeks of the study. From the WOMAC Physical Function sub-score the placebo group experienced a small improvement (d = 0.68) against the active group’s large improvement (d = 1.08). While for the WOMAC Composite score the active group experienced a large improvement (d = 1.07). In terms of the SF-36v2 Social Functioning and Pain sub scores, there was no change in score for the placebo group (d = 0.00), while the active group noticed an improvement by small (d = -0.34) and medium (d = -0.50) amounts, respectively. While for the SF-36v2 Emotional Well-Being and General Healthy Issues sub scores, the placebo-based subjects dis-improved over the 8 weeks (d = 0.07 and 0.15, respectively), while the subjects in the active group improved in both cases (d = -0.18) and -0.09, respectively). In terms of the SPPB, active group experienced an improvement in the Chair test and Total score. (d = 0.47 and d = -0.33, respectively). There was no difference in adverse events between groups (p > 0.05). The results demonstrated that daily oral doses of specific fish collagen peptides (Naticol®) in healthy subjects with knee osteoarthritis has the potential to reduce pain, improve quality of life and lower body function. Further studies with a higher dosage of product for subjects with a body weight greater than 70kg should be performed.
Our team has put together these clinical trial case studies in multiple topics to help you understand how we have assisted other sponsors in the past to tailor their clinical research programs.
Learn more about our company through our latest news. Articles have been worked on by members of our team. For media inquiries, please reach out to: marketing@atlantiatrials.com
Many of our clinical studies conducted are translated to published research papers in some of the top nutrition journals. You can discover our latest published work under this section.
