Diabetic Wound, Fermented Papaya Preparation, FPP, Healing Wound, Supplements
Conditions
Keywords
fermented papaya, wound healing responses
Brief summary
The objective of the current study is to determine the dose at which Fermented Papaya Preparation ( FPP) is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.
Detailed description
Fermented Papaya Preparation (FPP) is a dietary supplement that is available as over-the-counter in the US. FPP possesses antioxidant properties, which provide benefit against age-related complications\[\]. 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. Several independent observations convergently point toward the hypothesis that treatment with papaya preparations may facilitate wound healing responses. 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 the dose at which FPP is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.
Interventions
DIETARY_SUPPLEMENTFPP supplement
Participants will take the supplements per randomization
Sponsors
Osato Research Institute
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ages 18 and above * Subjects must be able to follow directions and give informed consent on their own
Exclusion criteria
* • Individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. Informed consent will be excluded. * Females who are pregnant will also be excluded to minimize the risk to such individuals (and fetus). * Individuals who are therapeutically immuno-compromised will also be excluded to decrease statistical variability and to minimize potential of confounders. * Candidates for inclusion into the study will not include individuals as defined in 45 CFR 46 Subparts B, C and D, nor from any other population which may be considered vulnerable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation | 6 weeks post supplementation | The major objectives of the study is to study the mechanism of action on ROS production by leucocytes of healthy subjects post 6 weeks FPP supplementation measured by flowcytometry |
| Blood leukocyte phagocytosis 6 weeks post supplementation | 6 weeks post supplementation | Blood leukocyte phagocytosis 6 weeks post supplementation via cell biology technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leukocyte activation and cytokine production at 6 wks post supplementation | 5 weeks | Blood leukocyte activation and cytokine production at 6 weeks post supplementation will be measured via flow cytometry |
Countries
United States
Outcome results
None listed