Clinical trial NCT02192047: Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
Official title: Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: International Medical University
name: Universiti Putra Malaysia
First posted: 2014-07-16
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in serum C-peptide level of subject
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Change in serum lipid profile
timeFrame: up to 8 weeks
measure: Change in markers of inflammation
timeFrame: up to 8 weeks
measure: Change in markers of obesity
timeFrame: up to 8 weeks
measure: Change in markers of insulin resistance
timeFrame: up to 8 weeks
measure: Oral Glucose tolerance test (OGTT)
timeFrame: Baseline, month-2
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: University Putra Malaysia
state: Selangor
Study officials:
affiliation: MPOB
name: Voon Phooi Tee, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: IMU
name: Ng Yen Teng, BSc
role: PRINCIPAL_INVESTIGATOR
References: