Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)

July 15, 2014 updated by: Malaysia Palm Oil Board

Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)

The investigators hypothesized that there will be a significant difference between the effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on cardiovascular disease, inflammation, insulin resistance and obesity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Human volunteers will be conditioned for a 8 wk intervention on 3 different test diets providing 30 % energy as fat, 15% energy as protein and 55% energy as carbohydrate according to parallel designed sequences. The test fats used for this study are palm oil, chemically interesterified palm oil and chemically interesterified fully hydrogenated soybean oil and soft oil blend in the form of margarine. Volunteers will be restricted to follow the dietary guidelines throughout the study. Blood collection sessions will held before and after every diet intervention. Outcome measures of the study are serum lipid profile, markers of inflammation, markers of obesity and insulin resistance.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • University Putra Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult males and females, aged 20-60 yr
  • Staff and students of International Medical University, IMU/ Staff of Malaysian Palm Oil Board, MPOB to facilitate centralized consumption of the test fats/snacks
  • BMI 21 - 30 kg/m2

Exclusion Criteria:

  • Abnomal liver function test (elevated transaminases- alanine aminotransferase,ALT; aspartate aminotransferase,AST))/ abnormal kidney function test (elevated plasma creatinine)
  • History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism
  • Smokers
  • On lipid/blood pressure- lowering medication/supplements
  • Blood pressure>140/90 mmHg
  • Fasting total cholesterol > 6.5 mmol/L
  • Fasting TAG > 2.0 mmol/L
  • Candidates who are going abroad during the planned schedule for the dietary intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: palm olein margarine
8 weeks
Other: Palm Olein
8 weeks
Experimental: IE palm olein margarine
8 weeks
Other: IE Palm olein
8 weeks
Experimental: IE soybean oil-based margarine
8 weeks
Other: IE soybean oil-based
8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum C-peptide level of subject
Time Frame: up to 8 weeks
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum lipid profile
Time Frame: up to 8 weeks
up to 8 weeks
Change in markers of inflammation
Time Frame: up to 8 weeks
up to 8 weeks
Change in markers of obesity
Time Frame: up to 8 weeks
up to 8 weeks
Change in markers of insulin resistance
Time Frame: up to 8 weeks
up to 8 weeks
Oral Glucose tolerance test (OGTT)
Time Frame: Baseline, month-2
Baseline, month-2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malaysia Palm Oil Board

Collaborators

Universiti Putra Malaysia
International Medical University

Investigators

  • Principal Investigator: Voon Phooi Tee, Ph.D, MPOB
  • Principal Investigator: Ng Yen Teng, BSc, IMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD 174/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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