Effects of a Spiced Meat Patty on Inflammation in Men With Type 2 Diabetes
Primary Purpose
Type II Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spice polyphenols
Sponsored by

About this trial
This is an interventional basic science trial for Type II Diabetes Mellitus focused on measuring MDA, Spice
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- David Geffen School of Medicine, UCLA Center for Human Nutrtiion
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Spice patty
salt patty
Arm Description
hamburger meat cooked with spice mixture
Subjects consume salt containing hamburger meat
Outcomes
Primary Outcome Measures
The protocol is designed to study the effect of spice on MDA production in hamburg meat
Secondary Outcome Measures
Full Information
NCT ID
NCT01076829
First Posted
February 25, 2010
Last Updated
June 9, 2014
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT01076829
Brief Title
Effects of a Spiced Meat Patty on Inflammation in Men With Type 2 Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
Detailed Description
10 male subjects with type 2 diabetes mellitus who will be recruited based on inclusion and exclusion criteria. The study will be carried out in accordance with the guidelines of the Human Subjects Protection Committee of the University of California, Los Angeles. All subjects will give written informed consent before the study begins. After the screening visit, each subject will come to the Center for Human Nutrition on two 1-day test phases separated by at least one week. At each of phases, subjects will consume, in a random order, two different test meals consisting of either: a) a ground dark meat beef patty seasoned with salt only, or b) a ground dark meat beef patty seasoned with a spice mixture and salt. The subjects will be asked to avoid eating high fat meat meals and all spice products for 3 days before the day of each of the two experimental phases
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
MDA, Spice
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spice patty
Arm Type
Active Comparator
Arm Description
hamburger meat cooked with spice mixture
Arm Title
salt patty
Arm Type
Placebo Comparator
Arm Description
Subjects consume salt containing hamburger meat
Intervention Type
Other
Intervention Name(s)
Spice polyphenols
Intervention Description
spice
Primary Outcome Measure Information:
Title
The protocol is designed to study the effect of spice on MDA production in hamburg meat
Time Frame
2 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoping Li, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Geffen School of Medicine, UCLA Center for Human Nutrtiion
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of a Spiced Meat Patty on Inflammation in Men With Type 2 Diabetes
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