Nutritional Regulation of Wound Inflammation: Part II (FPPT2DM-II)
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|ClinicalTrials.gov Identifier: NCT01618045|
Recruitment Status : Active, not recruiting
First Posted : June 13, 2012
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment|
|Diabetes||Dietary Supplement: Fermented Papaya Preparation (FPP)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Nutritional Regulation Of Wound Inflammation: Part II|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
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).
- 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 ]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 ]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 ]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).
- Lipid Profile [ Time Frame: Initial visit, 6 weeks of FPP supplementation, and 2 weeks after stopping FPP supplementation ]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
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): NCT01618045
|United States, Ohio|
|OSU CarePoint East|
|Columbus, Ohio, United States, 43203|
|University Hospital East (Wound Center)|
|Columbus, Ohio, United States, 43205|
|University Hospital East, OSUWMC Diabetes Clinic|
|Columbus, Ohio, United States, 43205|
|The Ohio State University/Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43210|
|OSUWMC Comprehensive Wound Care Center, Martha Morehouse Medical Plaza|
|Columbus, Ohio, United States, 43221|
|Principal Investigator:||Sashwati Roy, PhD.||Ohio State University|