Effects of a Spiced Meat Patty on Inflammation in Men With Type 2 Diabetes

Completed · Not applicable

Conditions studied: Type II Diabetes Mellitus

In brief

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: 1. 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). 2. 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. 3. 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.

Key facts

Study ID

NCT01076829

Run by

University of California, Los Angeles

People needed

10

Starts

2009-07-01

Expected to finish

2014-06-01

Last updated by the study team

2014-06-10

Who can join

Age: 35 and older, up to 70. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Have a diagnosis of Type II Diabetes Mellitus and currently being treated with oral medication but no insulin or glucose intolerant on no medications with a fasting blood sugar of > 110 mg/dl but less than 126 mg/dl fasting.
• Have an HbA1C lvel <9 % at Screening
• Male 35-70 years old
• Non-smokers, or smoke < 1 cigarette per day
• Must weigh a minimum of 110 pounds
• Willing to maintain normal activity and eating patterns for the duration of the study
• Willing to avoid meat, fish or poultry for three days on two occasions prior to the test procedure
• Consuming less than two alcoholic drinks per day
• Not taking dietary supplements
• No known allergy to beef, cloves, cinnamon, oregano, turmeric, cumin, rosemary, sage, red pepper, ginger, black pepper, paprika or garlic

You may not qualify if…

• Currently using insulin
• Abnormal liver function
• Currently taking steroidal drugs
• Known HIV positive or AIDS
• Chronic infectious disease
• Cancer treated within the past two years
• Participation in a therapeutic research study within 30 days of baseline
• Allergy to beef, cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika or tumeric
• History of hear failure with EF < 30, chronic renal failure with GFR < 30 ml/min
• Currently taking vasoactive medications such as but not limited to calcium channel blockers, nitrates, beta blockers, phosphodiesterase inhibitors
• History of Raynauds
• History of smoking within 5 years

Where it is running

• David Geffen School of Medicine, UCLA Center for Human Nutrtiion — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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