Clinical trial NCT05191758: Nutritional Regulation of Leukocyte Function
Official title: Nutritional Regulation of Leukocyte Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: FPP
Fermented Papaya Preparation
Supplements
Diabetic Wound
Healing Wound
Keywords: fermented papaya
wound healing responses
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Osato Research Institute
First posted: 2022-01-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation
timeFrame: 6 weeks post supplementation
measure: Blood leukocyte phagocytosis 6 weeks post supplementation
timeFrame: 6 weeks post supplementation
Secondary outcomes:
measure: Leukocyte activation and cytokine production at 6 wks post supplementation
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Sashwati Roy, PhD
role: PRINCIPAL_INVESTIGATOR
References: