Efficacy of a Hydrolyzed Chicken Collagen Type II in Alleviating Joint Discomfort
Condition: Joint Discomfort
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): AVC-H2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A total of 2.5g AVC-H2 daily (2 tablets in the morning and 2 in the evening); A total of 2.5g placebo daily (2 tablets in the morning and 2 in the evening)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care