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

Overweight Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192047
• Other study ID #: PD 174/13
• Status: Completed
• Phase: N/A
• First received: June 24, 2014
• Last updated: July 15, 2014
• Start date: September 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Overweight

Intervention

Other:
• Palm Olein
8 weeks
• IE Palm olein
8 weeks
• IE soybean oil-based
8 weeks

Locations

Country	Name	City	State
Malaysia	University Putra Malaysia	Serdang	Selangor

Sponsors (3)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	International Medical University, Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum C-peptide level of subject		up to 8 weeks	No
Secondary	Change in serum lipid profile		up to 8 weeks	No
Secondary	Change in markers of inflammation		up to 8 weeks	No
Secondary	Change in markers of obesity		up to 8 weeks	No
Secondary	Change in markers of insulin resistance		up to 8 weeks	No
Secondary	Oral Glucose tolerance test (OGTT)		Baseline, month-2	No