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

Study Overview
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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.

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.

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

Conditions
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Overweight

Intervention / Treatment
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* Other: Palm Olein
* Other: IE Palm olein
* Other: IE soybean oil-based


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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