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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01389492
First received: July 3, 2011
Last updated: July 6, 2011
Last verified: October 2009
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults, normal BMI

Exclusion Criteria:

  • Metabolic disorders
  • Smokers
  • Drinkers
  • Taking nutritional supplement
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Daniel Schurr, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01389492     History of Changes
Other Study ID Numbers: MWPP09-HMO-CTIL
Study First Received: July 3, 2011
Last Updated: July 6, 2011
Health Authority: Israel: Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
meat
LDL
MDA

ClinicalTrials.gov processed this record on August 21, 2014