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

Malaysia Palm Oil Board

Status: Completed

Conditions: Overweight

Treatments: Other: Palm Olein; Other: IE soybean oil-based; Other: IE Palm olein

Study type: Interventional

Funder types: Other

Identifiers

NCT02192047

PD 174/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

85 participants in 3 patient groups

palm olein margarine

Experimental group

Description:

8 weeks

Treatment:

Other: Palm Olein

IE palm olein margarine

Experimental group

Description:

8 weeks

Treatment:

Other: IE Palm olein

IE soybean oil-based margarine

Experimental group

Description:

8 weeks

Treatment:

Other: IE soybean oil-based