Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Regulation of Leukocyte Function (FPP Supplement)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05191758
Recruitment Status : Active, not recruiting
First Posted : January 13, 2022
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
Osato Research Institute
Information provided by (Responsible Party):
Sashwati Roy, Indiana University

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.

Condition or disease Intervention/treatment Phase
FPP Fermented Papaya Preparation Supplements Diabetic Wound Healing Wound Dietary Supplement: Supplement Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutritional Regulation of Leukocyte Function
Actual Study Start Date : February 15, 2022
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: no supplements
no supplements will be taken
Experimental: 3 grams of supplements
subjects will take 3 grams of supplements once per day
Dietary Supplement: Supplement
Participants will take the supplements per randomization
Other Names:
  • Fermented Papaya Preparation Supplement
  • FPP

Experimental: 6 grams of supplements
subjects will take 3 grams of supplements twice per day
Dietary Supplement: Supplement
Participants will take the supplements per randomization
Other Names:
  • Fermented Papaya Preparation Supplement
  • FPP

Experimental: 9 grams of supplements
subjects will take 3 grams of supplements three times per day
Dietary Supplement: Supplement
Participants will take the supplements per randomization
Other Names:
  • Fermented Papaya Preparation Supplement
  • FPP




Primary Outcome Measures :
  1. Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation [ Time Frame: 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

  2. Blood leukocyte function chemotaxis 6 weeks post supplementation [ Time Frame: 6 weeks post supplementation ]
    Blood leukocyte function chemotaxis 6 weeks post supplementation via cell biology technique


Secondary Outcome Measures :
  1. Leukocyte activation and cytokine production at 6 wks post supplementation [ Time Frame: 5 weeks ]
    Blood leukocyte activation and cytokine production at 6 weeks post supplementation will be measured via flow cytometry

  2. Blood leukocyte immune responses [ Time Frame: 5 weeks post supplementation ]
    Blood leukocyte phagocytosis tested using flowcytometry and ELISA for differences post supplementation immune responses



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191758


Locations
Layout table for location information
United States, Indiana
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46228
Sponsors and Collaborators
Indiana University
Osato Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Sashwati Roy, PhD Indiana University
Layout table for additonal information
Responsible Party: Sashwati Roy, Professor of Surgery, Indiana University
ClinicalTrials.gov Identifier: NCT05191758    
Other Study ID Numbers: 13229
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sashwati Roy, Indiana University:
fermented papaya
wound healing responses
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries