Nutritional Regulation of Leukocyte Function (FPP Supplement)

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.

Study Overview

• Status: Completed
• Conditions: Healing Wound; Diabetic Wound; Supplements; FPP; Fermented Papaya Preparation
• Intervention / Treatment: Dietary supplement: FPP supplement

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46228
      • Indiana University Health Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 grams of supplements; subjects will take 3 grams of supplements once per day	Dietary supplement: FPP supplement; Participants will take the supplements per randomization; Other Names: FPP; Fermented Papaya Preparation Supplement (FPP)
Experimental: 6 grams of supplements; subjects will take 3 grams of supplements twice per day	Dietary supplement: FPP supplement; Participants will take the supplements per randomization; Other Names: FPP; Fermented Papaya Preparation Supplement (FPP)
Experimental: 9 grams of supplements; subjects will take 3 grams of supplements three times per day	Dietary supplement: FPP supplement; Participants will take the supplements per randomization; Other Names: FPP; Fermented Papaya Preparation Supplement (FPP)
No Intervention: control; no supplements will be taken

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Osato Research Institute
• Investigators: Principal Investigator: Sashwati Roy, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): July 8, 2022
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: fermented papaya; wound healing responses
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 13229 (Other Identifier: City of Hope Medical Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No