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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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palm olein margarine

8 weeks

Group Type EXPERIMENTAL

Palm Olein

Intervention Type OTHER

8 weeks

IE palm olein margarine

8 weeks

Group Type EXPERIMENTAL

IE Palm olein

Intervention Type OTHER

8 weeks

IE soybean oil-based margarine

8 weeks

Group Type EXPERIMENTAL

IE soybean oil-based

Intervention Type OTHER

8 weeks

Interventions

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Palm Olein

8 weeks

Intervention Type OTHER

IE Palm olein

8 weeks

Intervention Type OTHER

IE soybean oil-based

8 weeks

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes