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The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers

Primary Purpose

Lipid Profile

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers
Sponsored by
Malaysia Palm Oil Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lipid Profile focused on measuring fat, inflammation, lipids, total cholesterol, Triglycerides, insulin sensitivity

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 18-45 years
  • BMI : 18.5-30 kg/m^2
  • Healthy, men

Exclusion Criteria:

  • medical history of cardiovascular disease, cancer, diabetes or chronic diseases
  • BMI < 18.5 OR > 30 kg/m^2
  • waist hip ratio > 0.9
  • total cholesterol > 5.2 mmol/L
  • triacylglycerol (TAG) > 2.2 mmol/L
  • current use of antihypertensive or lipid lowering medication

Sites / Locations

  • Malaysian Palm Oil Board

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

palm olein

olive oil

lard

Arm Description

Outcomes

Primary Outcome Measures

Triacylglycerol (TAG)

Secondary Outcome Measures

Insulin sensitivity (glucose, insulin), non-esterified fatty acids (NEFA), inflammatory markers

Full Information

First Posted
May 12, 2010
Last Updated
May 14, 2010
Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01124487
Brief Title
The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers
Official Title
The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid profile, insulin sensitivity and inflammatory markers. Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and inflammatory markers postprandially.
Detailed Description
A randomized, single blind, crossover design was undertaken to test meals enriched with palm olein vs olive oil vs lard. Volunteers were asked to participate in three postprandial challenges, separated by at least 3-days. Subjects were provided a low fat meal(<10g fat) the day before the intervention. Fasting blood was collected the next day and the subjects were instructed to consume test meals (50g high fat meal). Further venous blood was collected at 30 min, 1h, 2h, 3h and 4h postprandially. Primary outcome variable: Triacylglycerol (TAG) Secondary outcome variables: Insulin sensitivity (glucose, insulin), non esterified fatty acids (NEFA), inflammatory markers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Profile
Keywords
fat, inflammation, lipids, total cholesterol, Triglycerides, insulin sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
palm olein
Arm Type
Experimental
Arm Title
olive oil
Arm Type
Experimental
Arm Title
lard
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers
Primary Outcome Measure Information:
Title
Triacylglycerol (TAG)
Time Frame
4 h
Secondary Outcome Measure Information:
Title
Insulin sensitivity (glucose, insulin), non-esterified fatty acids (NEFA), inflammatory markers
Time Frame
4 h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 18-45 years BMI : 18.5-30 kg/m^2 Healthy, men Exclusion Criteria: medical history of cardiovascular disease, cancer, diabetes or chronic diseases BMI < 18.5 OR > 30 kg/m^2 waist hip ratio > 0.9 total cholesterol > 5.2 mmol/L triacylglycerol (TAG) > 2.2 mmol/L current use of antihypertensive or lipid lowering medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teng Kim Tiu, Msc
Organizational Affiliation
Malaysia Palm Oil Board and University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaysian Palm Oil Board
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia

12. IPD Sharing Statement

Learn more about this trial

The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers

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