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The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01389492
First Posted: July 8, 2011
Last Update Posted: July 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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.

Condition Intervention
Healthy Other: frozen meat cutlets meal Other: meat meals

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Nutritional Study:The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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

  • 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.


Enrollment: 14
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
frozen meat
250 g of frozen meat meal for 4 days
Other: frozen meat cutlets meal
250 g of meat cutlets
Other: meat meals
250 g of meat meal for 4 days
frozen meat and wine
250 g of frozen meat and red wine for 4 days
Other: frozen meat cutlets meal
250 g of meat cutlets
Other: meat meals
250 g of meat meal for 4 days
fresh meat
250 g of fresh meat meal
Other: frozen meat cutlets meal
250 g of meat cutlets
Other: meat meals
250 g of meat meal for 4 days
fresh meat and wine
250 g of fresh meat meal
Other: frozen meat cutlets meal
250 g of meat cutlets
Other: meat meals
250 g of meat meal for 4 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults, normal BMI

Exclusion Criteria:

  • Metabolic disorders
  • Smokers
  • Drinkers
  • Taking nutritional supplement
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01389492


Locations
Israel
The Hebrew University of Jerusalem
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: Shlomit Gorelik, PhD Hebrew University of Jerusalem
  More Information

Responsible Party: Dr. Daniel Schurr, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01389492     History of Changes
Other Study ID Numbers: MWPP09-HMO-CTIL
First Submitted: July 3, 2011
First Posted: July 8, 2011
Last Update Posted: July 8, 2011
Last Verified: October 2009

Keywords provided by Hadassah Medical Organization:
meat
LDL
MDA