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Dietary Supplement

6 grams of supplements for Familial Polyposis Syndrome (FPP Supplement Trial)

N/A
Waitlist Available
Led By Sashwati Roy, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks post supplementation
Awards & highlights

FPP Supplement 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.

Eligible Conditions
  • Familial Polyposis Syndrome
  • Fermented Papaya Preparation
  • Supplements
  • Diabetic Wounds
  • Wound Healing

FPP Supplement Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks post supplementation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks post supplementation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood leukocyte phagocytosis 6 weeks post supplementation
Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation
Secondary outcome measures
Leukocyte activation and cytokine production at 6 wks post supplementation

FPP Supplement Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: 9 grams of supplementsExperimental Treatment1 Intervention
subjects will take 3 grams of supplements three times per day
Group II: 6 grams of supplementsExperimental Treatment1 Intervention
subjects will take 3 grams of supplements twice per day
Group III: 3 grams of supplementsExperimental Treatment1 Intervention
subjects will take 3 grams of supplements once per day
Group IV: controlActive Control1 Intervention
no supplements will be taken
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FPP supplement
2022
N/A
~40

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,951 Total Patients Enrolled
Osato Research InstituteOTHER
5 Previous Clinical Trials
406 Total Patients Enrolled
Sashwati Roy, PhDPrincipal InvestigatorIndiana University
4 Previous Clinical Trials
169 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nutritional Regulation of Leukocyte Function
Dr. Sashwati Roy 2022. "Nutritional Regulation of Leukocyte Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05191758.
~10 spots leftby Apr 2025
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