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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389492
• Other study ID #: MWPP09-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: July 3, 2011
• Last updated: July 6, 2011
• Start date: October 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health - Director General
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy adults, normal BMI

Exclusion Criteria:

• Metabolic disorders

• Smokers

• Drinkers

• Taking nutritional supplement

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• frozen meat cutlets meal
250 g of meat cutlets
• meat meals
250 g of meat meal for 4 days

Locations

Country	Name	City	State
Israel	The Hebrew University of Jerusalem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma MDA levels following meat meal	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	No
Primary	Changes in MDA concentration on LDL fraction following meat meals	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	No