title: Clinical Assessment of Low-dose Osteoinductive Protein as a Stand-alone Regimen in Self-reported Osteoarthritis.
abstract: BACKGROUND
  Osteoarthritis, sometimes called degenerative joint disease, is the most common form of arthritis. It affects more than 20 million people in the United States, who mostly are older than age 45 y. No specific treatment exists to halt the progressive cartilage degeneration of osteoarthritis or to repair the damaged cartilage. Alternatives to pharmaceuticals include natural therapies and nutritional supplements.
  
  
  OBJECTIVE
  The present study examined the clinical response to daily supplementation with bioactive protein complex containing a collagen type 2 network, with associated growth factors, and osteoinductive proteins, known as bone morphogenetic proteins (BMPs).
  
  
  METHODS
  The research team designed an open-label preliminary study.
  
  
  METHODS
  Joint evaluations were self-administered by participants at their residences.
  
  
  METHODS
  Participants were 44 individuals with self-reported osteoarthritis in the hip, knee, or ankle (ie, in weight-bearing joints).
  
  
  METHODS
  Participants self-administered orally a low-dose form of the ingredient (ie, 150 mg of Cyplexinol(®) Standard, once daily for 4 wk).
  
  
  METHODS
  Four parameters-pain intensity, frequency of pain, activity level, and strength-were evaluated using a visual analog scale (VAS), both at baseline and at the end of the 4-wk period.
  
  
  RESULTS
  Pain intensity decreased 45% on a 10-cm VAS from 2.85 cm (P = .0001; 95% CI, 2.54, 3.16) at baseline to 1.41 cm (P = .0001; 95% CI, 1.18, 1.64) at wk 4. Pain frequency decreased 55% from 3.16 cm (P = .0001; 95% CI, 2.88, 3.44) at baseline to 1.22 cm (P = .0001; 95% CI, 0.85, 1.59) at wk 4. Activity level increased from 1.58 cm (P = .0001; 95% CI, 1.34, 1.82) at baseline to 2.91 cm (P = .0001; 95% CI, 2.71, 3.11) at wk 4. Strength increased 80% from 1.24 cm (P = .0001; 95% CI, 0.91, 1.57) at baseline to 2.10 cm (P = .0001; 95% CI, 1.73, 2.47) at wk 4.
  
  
  CONCLUSIONS
  The 44 participants reported subjective improvements in pain frequency and intensity as well as in activity level following administration of Cyplexinol(®). The results from this study identify the possible pathways associated with cartilage degradation, pain, and inflammation, which should be the focus of future research, and they suggest that the ingredient can be effective in helping to maintain joint homeostasis.
authors.affiliation: Fruitrition Nutrition in Greenville, South Carolina.
authors.forename: Katherine
authors.initials: K
authors.lastname: Spinks
authors.affiliation: ZyCal Bioceuticals in Shrewsbury, Massachusetts.
authors.forename: Matthew
authors.initials: M
authors.lastname: Walker
authors.affiliation: ZyCal Bioceuticals.
authors.forename: James
authors.initials: J
authors.lastname: Scaffidi