- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01389492
The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
July 6, 2011 updated by: Hadassah Medical Organization
Nutritional Study:The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
The postprandial increase in MDA level following meat meal could cause modification to LDL particles in healthy volunteers.
Co-consumption of food drived polyphenols with the meat will result in a significant decrease in LDL modification.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel, 91120
- The Hebrew University of Jerusalem
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults, normal BMI
Exclusion Criteria:
- Metabolic disorders
- Smokers
- Drinkers
- Taking nutritional supplement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: frozen meat
250 g of frozen meat meal for 4 days
|
250 g of meat cutlets
250 g of meat meal for 4 days
|
|
Other: frozen meat and wine
250 g of frozen meat and red wine for 4 days
|
250 g of meat cutlets
250 g of meat meal for 4 days
|
|
Other: fresh meat
250 g of fresh meat meal
|
250 g of meat cutlets
250 g of meat meal for 4 days
|
|
Other: fresh meat and wine
250 g of fresh meat meal
|
250 g of meat cutlets
250 g of meat meal for 4 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in plasma MDA levels following meat meal
Time Frame: Fasting before meal and 3, and 6 h postprandial, and fasting levels
|
After an overnight fast baseline (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes.
The subjects then ate a test meal within 30 min.
Blood samples (10 ml) were drawn 3 and 6 h after the meal was eaten.
Serum was separated from whole blood by centrifugation (910 g, 15 min), and MDA was evaluated by HPLC in plasma samples
|
Fasting before meal and 3, and 6 h postprandial, and fasting levels
|
|
Changes in MDA concentration on LDL fraction following meat meals
Time Frame: Fasting, before meal was eaten, 3 h following meal, at day 4, 3 h following meal consumption, and day 5 following over nigth fast
|
Subject consumed the test meals for 4 days.
Day 1, (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes.
The sbjects then ate a test meal within 30 min.
Blood samples (10 ml) were drawn 3 h after the meal was eaten.
Blood was collected at day 4, 3 h after the meal was eaten, at the morning of day 5.Plasma LDL was isolated using a single discontinuous density gradient ultracentrifugation.
The protein concentration was determined based on the method of Bradford.
MDA concentration was evaluated by HPLC.
|
Fasting, before meal was eaten, 3 h following meal, at day 4, 3 h following meal consumption, and day 5 following over nigth fast
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Shlomit Gorelik, PhD, Hebrew University of Jerusalem
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
July 3, 2011
First Submitted That Met QC Criteria
July 6, 2011
First Posted (Estimate)
July 8, 2011
Study Record Updates
Last Update Posted (Estimate)
July 8, 2011
Last Update Submitted That Met QC Criteria
July 6, 2011
Last Verified
October 1, 2009
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.