Nutritional Regulation of Leukocyte Function

Healing Wound Clinical Trial

— FPP Supplement  

Official title:

Nutritional Regulation of Leukocyte Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05191758
• Other study ID #: 13229
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Diabetic Wound
• Healing Wound
• Supplements
• Wounds and Injuries

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