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

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Other: IE soybean oil-based; Other: Palm Olein; Other: IE Palm olein

• Registration Number: NCT02192047
• Lead Sponsor: Malaysia Palm Oil Board

Brief Summary

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

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 Timeline

• Study Start: 2012-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-06-24
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Study First Posted: 2014-07-16
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IE soybean oil-based margarine	IE soybean oil-based	8 weeks
palm olein margarine	Palm Olein	8 weeks
IE palm olein margarine	IE Palm olein	8 weeks

Primary Outcome Measures

Name	Time	Method
Change in serum C-peptide level of subject	up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Putra Malaysia; 🇲🇾 Serdang, Selangor, Malaysia