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

July 3, 2011
July 6, 2011
October 2010
February 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01389492 on ClinicalTrials.gov Archive Site
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The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Other: frozen meat cutlets meal
    250 g of meat cutlets
  • Other: meat meals
    250 g of meat meal for 4 days
  • frozen meat
    250 g of frozen meat meal for 4 days
    Interventions:
    • Other: frozen meat cutlets meal
    • Other: meat meals
  • frozen meat and wine
    250 g of frozen meat and red wine for 4 days
    Interventions:
    • Other: frozen meat cutlets meal
    • Other: meat meals
  • fresh meat
    250 g of fresh meat meal
    Interventions:
    • Other: frozen meat cutlets meal
    • Other: meat meals
  • fresh meat and wine
    250 g of fresh meat meal
    Interventions:
    • Other: frozen meat cutlets meal
    • Other: meat meals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy adults, normal BMI

Exclusion Criteria:

  • Metabolic disorders
  • Smokers
  • Drinkers
  • Taking nutritional supplement
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01389492
MWPP09-HMO-CTIL
Yes
Dr. Daniel Schurr, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Study Director: Shlomit Gorelik, PhD Hebrew University of Jerusalem
Hadassah Medical Organization
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP