Nutritional Regulation of Wound Inflammation: Part II
Condition: Diabetes
MeSH terms: Inflammation
Study type: Observational

Summary: 
      Fermented Papaya Preparation (FPP) is a sweet and granular substance available over the
      counter. FPP possesses antioxidant properties, which provide benefit against age-related
      complications, and is also known to protect red blood cells (RBCs) against oxidative damage
      and to help protect against severe forms of thalassemia. The investigators recently showed
      that ex vivo supplementation of FPP can correct respiratory burst performance of diabetic
      peripheral blood mononuclear cells (PBMC) via a Sp-1 dependant pathway. Based on these
      observations, the investigators propose to study the outcome that FPP supplementation has in
      patients with diabetes.
    

Detailed description: 
      Fermented Papaya Preparation (FPP) possesses antioxidant properties, which provide benefit
      against age-related complications. FPP is also known to protect red blood cells (RBCs)
      against oxidative damage and to help protect against severe forms of thalassemia. Several
      independent observations convergently point toward the hypothesis that treatment with papaya
      preparations may facilitate wound healing responses. Chronic wounds in patients with diabetes
      represent a major public health problem. Previous studies from the investigators have
      demonstrated that wound-site macrophages from patients with diabetes are compromised in their
      ability to support wound healing. Recently, our laboratory reported the first evidence
      demonstrating that FPP may improve diabetic wound outcomes by specifically influencing the
      response of wound-site macrophages and the subsequent angiogenic response. FPP has a long
      track record of safe human consumption.

      The objective of the current study is to determine whether FPP is able to improve inducible
      respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) of participants with
      diabetes. Our investigators have recently reported that supplementation with standardized
      fermented papaya preparation (FPP) in adult diabetic mice improves dermal wound healing
      outcomes. The production of reactive oxygen species (ROS) by type 2 diabetics (T2DM) PBMC is
      markedly inhibited compared to that of the PBMC from non-diabetic donors. We observed that ex
      vivo FPP supplementation corrected such inhibition in ROS production by PBMC from T2DM
      donors. Therefore, based on these observations, the investigators propose to study the
      outcome that FPP supplementation has in patients with diabetes.
    

Intervention name(s): Fermented Papaya Preparation (FPP)
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will take fermented papaya preparation (FPP) for a total of 6 weeks (3 grams, three times each day for a total of 9 grams per day). The participants will attend 5 study visits and have their blood draw at each visit (5 total times).
Other intervention name(s): Immun'Age; FPP
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        The subject population in this study will be patients with type 2 diabetes with the
        following parameters.

          -  Age 30 to 80 years old

          -  HbA1c ≤ 9. 0

          -  BMI between 22-42
      
Biospecimen description: 
      Blood will be drawn for the study.
    
Keywords: Diabetes; FPP; fermented papaya preparation