Nutritional Regulation of Leukocyte Function

NCT ID: NCT05191758

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2023-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control

no supplements will be taken

Group Type: NO_INTERVENTION

No interventions assigned to this group

3 grams of supplements

subjects will take 3 grams of supplements once per day

Group Type: EXPERIMENTAL

FPP supplement

Intervention Type: DIETARY_SUPPLEMENT

Participants will take the supplements per randomization

6 grams of supplements

subjects will take 3 grams of supplements twice per day

Group Type: EXPERIMENTAL

FPP supplement

Intervention Type: DIETARY_SUPPLEMENT

Participants will take the supplements per randomization

9 grams of supplements

subjects will take 3 grams of supplements three times per day

Group Type: EXPERIMENTAL

FPP supplement

Intervention Type: DIETARY_SUPPLEMENT

Participants will take the supplements per randomization

Interventions

FPP supplement

Participants will take the supplements per randomization

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Fermented Papaya Preparation Supplement (FPP); FPP

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Osato Research Institute

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sashwati Roy

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sashwati Roy, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

13229

Identifier Type: -

Identifier Source: org_study_id