Nutritional Regulation of Leukocyte Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nutritional Regulation of Leukocyte Function

Conditions
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FPP, Fermented Papaya Preparation, Supplements, Diabetic Wound, Healing Wound

Intervention / Treatment
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* Dietary Supplement: FPP supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>no supplements will be taken | |
| Experimental: 3 grams of supplements<br>subjects will take 3 grams of supplements once per day | Dietary Supplement: FPP supplement<br>* Participants will take the supplements per randomization<br>* Other names: FPP;|
| Experimental: 6 grams of supplements<br>subjects will take 3 grams of supplements twice per day | Dietary Supplement: FPP supplement<br>* Participants will take the supplements per randomization<br>* Other names: FPP;|
| Experimental: 9 grams of supplements<br>subjects will take 3 grams of supplements three times per day | Dietary Supplement: FPP supplement<br>* Participants will take the supplements per randomization<br>* Other names: FPP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fermented papaya, wound healing responses