Nutritional Regulation of Wound Inflammation: Part II (FPPT2DM-II)

This study is currently recruiting participants.
Verified December 2013 by Ohio State University
Sponsor:
Collaborator:
Osato Research Foundation
Information provided by (Responsible Party):
Sashwati Roy, Ohio State University
ClinicalTrials.gov Identifier:
NCT01618045
First received: June 11, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Fermented Papaya Preparation (FPP) is a sweet and granular substance available over the counter. FPP possesses antioxidant properties, which provide benefit against age-related complications, and is also known to protect red blood cells (RBCs) against oxidative damage and to help protect against severe forms of thalassemia. The investigators recently showed that ex vivo supplementation of FPP can correct respiratory burst performance of diabetic peripheral blood mononuclear cells (PBMC) via a Sp-1 dependant pathway. Based on these observations, the investigators propose to study the outcome that FPP supplementation has in patients with diabetes.


Condition Intervention
Diabetes
Dietary Supplement: Fermented Papaya Preparation (FPP)

Study Type: Observational
Official Title: Nutritional Regulation Of Wound Inflammation: Part II

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Blood glucose level [ Time Frame: Initial visit, 2 weeks of FPP supplementation, 6 weeks of FPP supplementation, 1 week after stopping FPP supplementation, and 2 weeks after stopping FPP supplementation ] [ Designated as safety issue: Yes ]
    The blood glucose level will be measured from blood drawn via venipuncture at each study visit throughout the duration of the study.

  • HbA1c level [ Time Frame: Initial visit, 2 weeks of FPP supplementation, 6 weeks of FPP supplementation, and 2 weeks after stopping FPP supplementation ] [ Designated as safety issue: Yes ]
    HbA1c level will be measured from blood drawn from venipuncture to assess any change in the level during FPP supplementation and after stopping FPP supplementation.

  • Monocyte Function [ Time Frame: Initial visit, 2 weeks of FPP supplementation, 6 weeks of FPP supplementation, 1 week after stopping FPP supplementation, and 2 weeks after stopping FPP supplementation ] [ Designated as safety issue: No ]
    Blood drawn from venipuncture at each study visit will be assessed to determine monocyte reactive oxygen species (ROS) production and NADPH oxidase expression (Rac2 levels).


Secondary Outcome Measures:
  • Lipid Profile [ Time Frame: Initial visit, 6 weeks of FPP supplementation, and 2 weeks after stopping FPP supplementation ] [ Designated as safety issue: No ]
    Lipid profile (cholesterol levels) will be measured from blood drawn via venipuncture to assess for any changes during FPP supplementation and after stopping FPP supplementation.


Biospecimen Retention:   Samples Without DNA

Blood will be drawn for the study.


Estimated Enrollment: 25
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fermented Papaya Preparation (FPP)
This a is single arm study - all participants will receive and take fermented papaya preparation (FPP) for a total of 6 weeks. Participants will take 3 grams of FPP three times per day (a total of 9 grams per day).
Dietary Supplement: Fermented Papaya Preparation (FPP)
Participants will take fermented papaya preparation (FPP) for a total of 6 weeks (3 grams, three times each day for a total of 9 grams per day). The participants will attend 5 study visits and have their blood draw at each visit (5 total times).
Other Names:
  • Immun'Age
  • FPP

Detailed Description:

Fermented Papaya Preparation (FPP) possesses antioxidant properties, which provide benefit against age-related complications. FPP is also known to protect red blood cells (RBCs) against oxidative damage and to help protect against severe forms of thalassemia. Several independent observations convergently point toward the hypothesis that treatment with papaya preparations may facilitate wound healing responses. 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. Recently, 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 whether FPP is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) of participants with diabetes. Our investigators have recently reported that supplementation with standardized fermented papaya preparation (FPP) in adult diabetic mice improves dermal wound healing outcomes. The production of reactive oxygen species (ROS) by type 2 diabetics (T2DM) PBMC is markedly inhibited compared to that of the PBMC from non-diabetic donors. We observed that ex vivo FPP supplementation corrected such inhibition in ROS production by PBMC from T2DM donors. Therefore, based on these observations, the investigators propose to study the outcome that FPP supplementation has in patients with diabetes.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The subject population in this study will be patients with type 2 diabetes with the following parameters.

  • Age 30 to 80 years old
  • HbA1c ≤ 9. 0
  • BMI between 22-42
Criteria

Inclusion Criteria:

  • Adult patients 30 to 80 years old with clinically defined type II diabetes and HbA1c ≤ 9.0 and BMI between 22 and 42
  • Diabetic subjects selected for the study will meet one or more of the following criteria as recommended by American Diabetes Association:
  • 1) Symptoms of diabetes and casual plasma glucose 200 mg/dl (11.1 mmol/l) (casual is defined as any time of day without regard to time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss); OR
  • 2) Fasting plasma glucose (FPG) 126 mg/dl (7.0 mmol/l) (fasting is defined as no caloric intake for at least 8 h); OR
  • 3) 2-hr plasma glucose 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (OGTT) (this test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water)

Exclusion Criteria:

  • Individuals who are deemed unable to understand the procedures, risks and benefits of the study (i.e., informed consent) will be excluded
  • T2DM with HbA1c = 9.1 or above
  • BMI less than 22 and over 42
  • Clinically significant kidney or liver disease
  • Severe neurologic dysfunction
  • Females who are pregnant as well as individuals who are therapeutically immuno-compromised will also be excluded in order to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize the 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
  • Pregnant women are excluded to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize the potential of confounders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618045

Contacts
Contact: Andrea Colcord, RN, MPH 614-293-0390 andrea.colcord@osumc.edu

Locations
United States, Ohio
The Ohio State University/Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Andrea Colcord, RN, MPH    614-293-0390    andrea.colcord@osumc.edu   
Sub-Investigator: Chandan K Sen, PhD         
Sub-Investigator: Gayle Gordillo, MD.         
Principal Investigator: Sashwati Roy, PhD         
University Hospital East (Wound Center) Recruiting
Columbus, Ohio, United States, 43205
OSUWMC Comprehensive Wound Care Center, Martha Morehouse Medical Plaza Recruiting
Columbus, Ohio, United States, 43221
OSU CarePoint East Recruiting
Columbus, Ohio, United States, 43203
University Hospital East, OSUWMC Diabetes Clinic Recruiting
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Ohio State University
Osato Research Foundation
Investigators
Principal Investigator: Sashwati Roy, PhD. Ohio State University
  More Information

No publications provided

Responsible Party: Sashwati Roy, Associate professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01618045     History of Changes
Other Study ID Numbers: 20120293
Study First Received: June 11, 2012
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Diabetes
FPP
fermented papaya preparation

Additional relevant MeSH terms:
Diabetes Mellitus
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014