Joint pain and disease affect more than one in four adults in the United States. We conducted a double-blind, randomized, placebo-controlled trial to investigate the efficacy of a hydrolyzed chicken collagen type II (HCII) supplement in reducing joint-related discomfort such as pain and stiffness, and in improving mobility. We enrolled adults aged 40-65y (65.5% were women) who had joint discomfort, but had no co-morbidities, and were not taking pain medications. The participants were randomized to receive either the HCII supplement (n=47) or a placebo (n=43) for eight weeks. At baseline, week 4, and week 8, we administered the Western Ontario and McMaster Universities Arthritis Index (WOMAC) survey with three additional wrist-related questions and the Visual Analog Scale for assessments of joint-related symptoms.
Joint pain and disease affects more than one in four adults in the United States. Hydrolyzed Chicken Collagen Type II, hereinafter referred to as HCII, may repair or regenerate deteriorating collagen, and therefore, help address the underlying cause of joint discomfort. This study evaluated the efficacy of Avicenna's patented Hydrolyzed Chicken Collagen Type II product, hereinafter referred to as AVC-H2, in the reduction of joint pain \& stiffness and improvement in joint function. BioScreen Clinical Services conducted a double-blind, randomized, placebo-controlled trial. 90 participants were enrolled, 47 in the AVC-H2 group and 43 in the placebo group; aged 40-65 with overall joint discomfort but no co-morbidities were enrolled. Participants in both groups took two pills in the morning and evening for 8 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) survey with the addition of 3 questions pertaining to the wrist and Visual Analog Scale (VAS) for pain assessment were conducted at baseline, week 4, and week 8. The product used was Avicenna's Hydrolyzed Chicken Collagen Type II raw material product. The techniques used to create AVC-H2 mimic the body's natural hydrolysis process for ease of digestion and optimum low molecular weight. AVC-H2 protein consists of protein bonds that have been broken down or "untied" so that they are more easily absorbed by the small intestines. The total collagen in the product is ≥ 70%, making it a highly pure product, in comparison to other collagen products that were tested prior to the study. Total collagen content of AVC-H2 was based off of certificates of analyses prior to the study. As such, a smaller dosage was administered to participants compared to previous studies of similar products. Participants in the study were randomly assigned to receive either 2.5g of AVC-H2 daily or a matching amount of placebo. Intent to Treat Analysis and Sensitivity Analysis were both used. Intent to Treat Analysis included all study participants and Sensitivity Analysis removed participants who broke protocol and those who initially claimed they had 0 joint pain \& stiffness. To the investigators' knowledge, Avicenna's study appears to be the first to assess the efficacy of HCII on joint discomfort in the wrist and in individuals not taking additional pain medications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
90
Avicenna Nutraceutical
Atlanta, Georgia, United States
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Baseline
The WOMAC survey is used to assess joint-related discomfort at baseline. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).
Time frame: Baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Midpoint (Week 4)
The WOMAC survey is used to assess joint-related discomfort at midpoint of the study. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).
Time frame: Week 4
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Endpoint (Week 8)
The WOMAC survey is used to assess joint-related discomfort at endpoint of the study. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).
Time frame: Week 8
The Visual Analog Scale (VAS) - Baseline
VAS is used for pain assessment at baseline. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.
Time frame: Baseline
The Visual Analog Scale (VAS) - Midpoint (Week 4)
VAS is used for pain assessment at midpoint. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.
Time frame: Week 4
The Visual Analog Scale (VAS) - Endpoint (Week 8)
VAS is used for pain assessment at endpoint. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.
Time frame: Week 8
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