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Completed

NCT Number: NCT05191758

Nutritional Regulation of Leukocyte Function

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46228, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FPP supplement

Dietary Supplement

Participants will take the supplements per randomization

Other names: Fermented Papaya Preparation Supplement (FPP), FPP

Primary outcomes

  1. Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation

    Time frame: 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

  2. Blood leukocyte phagocytosis 6 weeks post supplementation

    Time frame: 6 weeks post supplementation

    Blood leukocyte phagocytosis 6 weeks post supplementation via cell biology technique

Secondary outcomes

  1. Leukocyte activation and cytokine production at 6 wks post supplementation

    Time frame: 5 weeks

    Blood leukocyte activation and cytokine production at 6 weeks post supplementation will be measured via flow cytometry

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Osato Research Institute

Registry information

Acronym: FPP Supplement

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 13, 2022
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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