Nutritional Regulation of Leukocyte Function

NCT05191758 | Completed

• 1 other identifier: 13229
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

FPP; Fermented Papaya Preparation; Supplements; Diabetic Wound; Healing Wound

Keywords

fermented papaya; wound healing responses

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Leukocyte activation and cytokine production at 6 wks post supplementation

  5 weeks

Study Arms (4)

control

NO INTERVENTION

no supplements will be taken

3 grams of supplements

EXPERIMENTAL

subjects will take 3 grams of supplements once per day

Dietary Supplement: FPP supplement

6 grams of supplements

EXPERIMENTAL

subjects will take 3 grams of supplements twice per day

Dietary Supplement: FPP supplement

9 grams of supplements

EXPERIMENTAL

subjects will take 3 grams of supplements three times per day

Dietary Supplement: FPP supplement

Interventions

FPP supplement DIETARY_SUPPLEMENT

Participants will take the supplements per randomization

Also known as: Fermented Papaya Preparation Supplement (FPP), FPP

3 grams of supplements; 6 grams of supplements; 9 grams of supplements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 and above
• Subjects must be able to follow directions and give informed consent on their own

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Osato Research Institute: collaborator

Study Sites (1)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46228, United States

Location

Study Officials

• Sashwati Roy, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 13, 2022
• Study Start: February 15, 2022
• Primary Completion: July 8, 2022
• Study Completion: July 31, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)