Nutritional Regulation of Wound Inflammation: Part II

NCT01618045 | Completed

• 1 other identifier: 20120293
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Diabetes

Keywords

Diabetes; FPP; fermented papaya preparation

Outcome Measures

Primary Outcomes (3)

• Blood glucose level

  The blood glucose level will be measured from blood drawn via venipuncture at each study visit throughout the duration of the study.

  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

• HbA1c level

  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.

  Initial visit, 2 weeks of FPP supplementation, 6 weeks of FPP supplementation, and 2 weeks after stopping FPP supplementation

• Monocyte Function

  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).

  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

Secondary Outcomes (1)

• Lipid Profile

  Initial visit, 6 weeks of FPP supplementation, and 2 weeks after stopping FPP supplementation

Study Arms (1)

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)

Interventions

Fermented Papaya Preparation (FPP) DIETARY_SUPPLEMENT

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).

Also known as: Immun'Age, FPP

Fermented Papaya Preparation (FPP)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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:
• \) 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
• \) Fasting plasma glucose (FPG) 126 mg/dl (7.0 mmol/l) (fasting is defined as no caloric intake for at least 8 h); OR
• \) 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ohio State University: lead
• Osato Research Institute: collaborator

Study Sites (5)

OSU CarePoint East

Columbus, Ohio, 43203, United States

Location

University Hospital East (Wound Center)

Columbus, Ohio, 43205, United States

Location

University Hospital East, OSUWMC Diabetes Clinic

Columbus, Ohio, 43205, United States

Location

The Ohio State University/Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

OSUWMC Comprehensive Wound Care Center, Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be drawn for the study.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

fermented papaya preparation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sashwati Roy, PhD.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: May 1, 2012
• Primary Completion: January 19, 2015
• Study Completion: February 19, 2015
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (5)