Effects of a Spiced Meat Patty on Inflammation in Men With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01076829|
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : June 10, 2014
Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly, in response to biotic or abiotic stresses such as infections, wounding, UV irradiation, exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that the molecular basis for the protective action of polyphenols in plants is their antioxidant and free radical scavenging properties. These numerous phenolic compounds are major biologically active components of spices, aromas, essential oils, and traditional medicines. In order to investigate the impact of spice polyphenols on postprandial flow-mediated dilation, nitric oxide, glucose, insulin, triglycerieds, oxidized LDL, and cytoxic lipid peroxidation products (MDA) levels in men with type 2 diabetes, the investigators propose to achieve the following specific aims using a randomized crossover study design:
- To determine the effect of a ground beef patty meal with and without polyphenol-rich spices on postprandial levels of plasma oxidized LDL, triglycerides, insulin, glucose, and malondialdehyde (MDA).
- To determine the effect of a ground beef patty meal with and without polyphenol-rich spices on postprandial levels of nitric oxide and flow-mediated dilation.
- To determine the effect of a ground beef patty meal with and without a spice blend on MDA accumulation in urine.
This study will determine whether spice polyphenols exert a beneficial effect by inhibition of the absorption of lipotoxin MDA in males with type 2 diabetes mellitus.Men with diabetes mellitus type 2 have been selected for this study to enable assessment of markers of vascular health including nitric oxide in plasma and flow-mediated dilation. These findings may help to explain the potentially harmful effects of oxidizable fats found in foods and the important benefit of dietary polyphenols in ameliorating this potentially harmful effect.
|Condition or disease||Intervention/treatment||Phase|
|Type II Diabetes Mellitus||Other: Spice polyphenols||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Inhibition of Absorption of Cytoxic Lipid Peroxidation Products and Abnormalities of Postprandial Endothelial Function by Spice Polyphenols Fed Together With High Fat Meat Patty in Men With Type 2 Diabetes Mellitus or Impaired Glucose Tolerance|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: Spice patty
hamburger meat cooked with spice mixture
Other: Spice polyphenols
Placebo Comparator: salt patty
Subjects consume salt containing hamburger meat
Other: Spice polyphenols
- The protocol is designed to study the effect of spice on MDA production in hamburg meat [ Time Frame: 2 days ]
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): NCT01076829
|United States, California|
|David Geffen School of Medicine, UCLA Center for Human Nutrtiion|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Zhaoping Li, MD||University of California, Los Angeles|