Short-term Impact of Cyplexinol® on Self-reported Joint Pain
Condition: Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      In this study, the impact of 900 mg Cyplexinol® taken daily on joint pain over a period of 15
      days in comparison with a placebo will be determined using a cross-over double blind design
      with a 13 day wash out period. In addition, we will measure cytokine production and related
      variables during the two hour after subjects ingest a single dosage of Cyplexinol® or placebo
      on days 1 and 15.
    

Detailed description: 
      Chronic inflammation can induce joint pain, which is a common problem among adult men and
      women. ZyCal Bioceuticals is a manufacturer of natural ingredients and finished nutritional
      supplements to support bone and joint health in humans. The core ingredient in all ZyCal
      products is Cyplexinol® (a Bone Morphogenetic Protein [BMP] Complex). BMP complexes have been
      shown to activate mesenchymal stem cells to help the body regenerate osteoblasts and
      chondrocytes. BMPs were initially identified in the 1970's as osteogenic factors which
      stimulate activation, proliferation, and differentiation of osteoprogenitor cells by binding
      BMP receptors and subsequent signaling through the SMAD pathway. BMPs have also been shown to
      reduce inflammation and promote healthy inflammatory signaling in joints and other tissues.

      Cyplexinol® is delivered in the dietary supplement called Ostinol™, which has been safely
      used in oral form by thousands of people since 2007 for bone and joint health. Currently
      Cyplexinol® is considered a dietary supplement ingredient and has been awarded GRAS
      (generally recognized as safe).

      Studies have been conducted to evaluate the safety and efficacy of Cyplexinol® as a dietary
      supplement for joint health (Garian, 2012; Scaffidi, 2017). Dosages of 150mg Cyplexinol® have
      been compared to a placebo (negative control) alone or in combination with glucosamine
      /chondroitin in randomized controlled trials for 4 -12 weeks. Endpoints examined have
      included joint stiffness, inflammation, pain, and overall quality of life. However, to date,
      no short-term studies have been conducted using Cyplexinol®, nor have any acute studies
      evaluated the impact of this agent on immune function.

      In this study, the impact of 900 mg Cyplexinol® taken daily on joint pain over a period of 15
      days in comparison with a placebo will be determined using a cross-over double blind design
      with a 13 day wash out period. In addition, we will measure cytokine production and related
      variables during the two hour post ingestion period after subjects ingest a single dosage of
      Cyplexinol® or placebo on days 1 and 15.
    

Intervention name(s): Cyplexinol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs); Maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, randomized, control
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Cyplexinol; Inflammation