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

NCT01076829 | Completed

• 1 other identifier: 08-11-023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 3.To determine the effect of a ground beef patty meal with and without a spice blend on MDA accumulation in urine.

Conditions

Type II Diabetes Mellitus

Keywords

MDA; Spice

Outcome Measures

Primary Outcomes (1)

• The protocol is designed to study the effect of spice on MDA production in hamburg meat

  2 days

Study Arms (2)

Spice patty

ACTIVE COMPARATOR

hamburger meat cooked with spice mixture

Other: Spice polyphenols

salt patty

PLACEBO COMPARATOR

Subjects consume salt containing hamburger meat

Other: Spice polyphenols

Interventions

Spice polyphenols OTHER

spice

Spice patty; salt patty

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

David Geffen School of Medicine, UCLA Center for Human Nutrtiion

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhaoping Li, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UCLA Center for Human Nutrition, Chief

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: July 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 10, 2014

Record last verified: 2013-12

Locations

US (1)