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| Name | Class |
|---|---|
| Osato Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | no supplements will be taken | |
| 3 grams of supplements | Experimental | subjects will take 3 grams of supplements once per day |
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| 6 grams of supplements | Experimental | subjects will take 3 grams of supplements twice per day |
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| 9 grams of supplements | Experimental | subjects will take 3 grams of supplements three times per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FPP supplement | Dietary Supplement | Participants will take the supplements per randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reactive Oxygen species (ROS) production of Leucocytes 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 | 6 weeks post supplementation |
| Blood leukocyte phagocytosis 6 weeks post supplementation | Blood leukocyte phagocytosis 6 weeks post supplementation via cell biology technique | 6 weeks post supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Leukocyte activation and cytokine production at 6 wks post supplementation | Blood leukocyte activation and cytokine production at 6 weeks post supplementation will be measured via flow cytometry | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
• Individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. Informed consent will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Sashwati Roy, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46228 | United States |
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