Nutritional Regulation of Leukocyte Function

Not Applicable

Completed

• Conditions: FPP; Healing Wound; Fermented Papaya Preparation; Diabetic Wound; Supplements
• Interventions: Dietary Supplement: FPP supplement

• Registration Number: NCT05191758
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-13
• Study Start: 2022-02-15
• Primary Completion: 2022-07-08
• Study Completion: 2023-07-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 grams of supplements	FPP supplement	subjects will take 3 grams of supplements once per day
6 grams of supplements	FPP supplement	subjects will take 3 grams of supplements twice per day
9 grams of supplements	FPP supplement	subjects will take 3 grams of supplements three times per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States