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

N/ACompletedNCT02192047

Malaysia Palm Oil Board85 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Overweight

Interventions

Palm OleinOTHER

8 weeks

IE Palm oleinOTHER

8 weeks

IE soybean oil-basedOTHER

8 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Putra Malaysia

Serdang, Selangor, Malaysia

Outcomes

Primary Outcomes

Change in serum C-peptide level of subject

Time frame: up to 8 weeks

Secondary Outcomes

Change in serum lipid profile

Time frame: up to 8 weeks

Change in markers of inflammation

Time frame: up to 8 weeks

Change in markers of obesity

Time frame: up to 8 weeks

Change in markers of insulin resistance

Time frame: up to 8 weeks

Oral Glucose tolerance test (OGTT)

Time frame: Baseline, month-2

Data from ClinicalTrials.gov

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