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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05191758
Other study ID # 13229
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date July 31, 2023

Study information

Verified date August 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date July 31, 2023
Est. primary completion date July 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Dietary Supplement:
FPP supplement
Participants will take the supplements per randomization

Locations

Country Name City State
United States Indiana University Health Methodist Hospital Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University Osato Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Blood leukocyte phagocytosis 6 weeks post supplementation Blood leukocyte phagocytosis 6 weeks post supplementation via cell biology technique 6 weeks post supplementation
Secondary 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
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