Nutritional Regulation of Leukocyte Function (FPP Supplement)

Indiana University

Status: Completed

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

Treatments: Dietary Supplement: FPP supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05191758

13229 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 4 patient groups

control

No Intervention group

Description:

no supplements will be taken

3 grams of supplements

Experimental group

Description:

subjects will take 3 grams of supplements once per day

Treatment:

Dietary Supplement: FPP supplement

6 grams of supplements

Experimental group

Description:

subjects will take 3 grams of supplements twice per day

Treatment:

Dietary Supplement: FPP supplement

9 grams of supplements

Experimental group

Description:

subjects will take 3 grams of supplements three times per day

Treatment:

Dietary Supplement: FPP supplement