NCT01389492

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
Last Updated

July 8, 2011

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

July 3, 2011

Last Update Submit

July 6, 2011

Conditions

Keywords

meatLDLMDA

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (4)

frozen meat

OTHER

250 g of frozen meat meal for 4 days

Other: frozen meat cutlets mealOther: meat meals

frozen meat and wine

OTHER

250 g of frozen meat and red wine for 4 days

Other: frozen meat cutlets mealOther: meat meals

fresh meat

OTHER

250 g of fresh meat meal

Other: frozen meat cutlets mealOther: meat meals

fresh meat and wine

OTHER

250 g of fresh meat meal

Other: frozen meat cutlets mealOther: meat meals

Interventions

250 g of meat cutlets

fresh meatfresh meat and winefrozen meatfrozen meat and wine

250 g of meat meal for 4 days

fresh meatfresh meat and winefrozen meatfrozen meat and wine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults, normal BMI

You may not qualify if:

  • Metabolic disorders
  • Smokers
  • Drinkers
  • Taking nutritional supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hebrew University of Jerusalem

Jerusalem, 91120, Israel

Location

Study Officials

  • Shlomit Gorelik, PhD

    Hebrew University of Jerusalem

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2011

First Posted

July 8, 2011

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

May 1, 2011

Last Updated

July 8, 2011

Record last verified: 2009-10

Locations