Acute Effects of Natural and Interesterified Fats-margarine on Lipemic and Insulinemic Response

July 16, 2014 updated by: Malaysia Palm Oil Board

Acute Effects of Natural and Interesterified Fats-formulated Margarine on Lipemic and Insulinemic Response

Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and insulinemic responses compare to a trans free palm margarine (TFPM).

Study Overview

Detailed Description

The objective of this study was to investigate whether IE-fat blends behave differently on postprandial serum lipid, insulin, C-peptide and glucose concentration compare to TFPM. A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults. During postprandial challenge day, each subject received an a test muffin incorporated with test margarine. Blood samples were collected at half-hourly intervals until 4 hr by using cannulation technique.

Study Type

Interventional

Enrollment (Actual)

20

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

    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • MalaysiaPOB

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass Index (BMI) between 18.5 and 24.9
  • <130mmHg for systolic pressure and <80 mmHg for diastolic pressure
  • Blood glucose level in the range of 3.9 to 5.5 mmol/L
  • Total cholesterol less than 5.17 mmol/L
  • No use of tobacco and no consumption of alcohol.

Exclusion Criteria:

  • Suffer from chronic disease
  • Metabolic syndrome
  • Consuming any medical prescriptions
  • People with blood clotting problem
  • Women who are pregnant
  • Hypertensive person

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trans free palm margarine
One high fat muffin will be serves together with a glass of low fat milk shake.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
Experimental: Interesterified palm based margarine
One high fat muffin will be serves together with a glass of low fat milk shake.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
Experimental: IE soybean oil-based margarine
One high fat muffin will be serves together with a glass of low fat milk shake.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum triglycerides level of subjects as a measure of postprandial triglycerides response
Time Frame: Baseline, 4 hours
Baseline, 4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the level of plasma insulin, c-peptide and serum glucose as a measure of postprandial insulinemic response
Time Frame: Baseline, 4 hours
Baseline, 4 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Voon Phooi Tee, Ph.D, Malaysia Palm Oil Board

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

January 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • AH 00112

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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