Back to resultsChronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Palm Olein
IE Palm olein
IE soybean oil-based
Sponsored by
About this trial
This is an interventional basic science trial for Overweight
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
Sites / Locations
- University Putra Malaysia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
palm olein margarine
IE palm olein margarine
IE soybean oil-based margarine
Arm Description
8 weeks
8 weeks
8 weeks
Outcomes
Primary Outcome Measures
Change in serum C-peptide level of subject
Secondary Outcome Measures
Change in serum lipid profile
Change in markers of inflammation
Change in markers of obesity
Change in markers of insulin resistance
Oral Glucose tolerance test (OGTT)
Full Information
NCT ID
NCT02192047
First Posted
June 24, 2014
Last Updated
July 15, 2014
Sponsor
Malaysia Palm Oil Board
Collaborators
International Medical University, Universiti Putra Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT02192047
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malaysia Palm Oil Board
Collaborators
International Medical University, Universiti Putra Malaysia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
palm olein margarine
Arm Type
Experimental
Arm Description
8 weeks
Arm Title
IE palm olein margarine
Arm Type
Experimental
Arm Description
8 weeks
Arm Title
IE soybean oil-based margarine
Arm Type
Experimental
Arm Description
8 weeks
Intervention Type
Other
Intervention Name(s)
Palm Olein
Intervention Description
8 weeks
Intervention Type
Other
Intervention Name(s)
IE Palm olein
Intervention Description
8 weeks
Intervention Type
Other
Intervention Name(s)
IE soybean oil-based
Intervention Description
8 weeks
Primary Outcome Measure Information:
Title
Change in serum C-peptide level of subject
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Change in serum lipid profile
Time Frame
up to 8 weeks
Title
Change in markers of inflammation
Time Frame
up to 8 weeks
Title
Change in markers of obesity
Time Frame
up to 8 weeks
Title
Change in markers of insulin resistance
Time Frame
up to 8 weeks
Title
Oral Glucose tolerance test (OGTT)
Time Frame
Baseline, month-2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Voon Phooi Tee, Ph.D
Organizational Affiliation
MPOB
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ng Yen Teng, BSc
Organizational Affiliation
IMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Putra Malaysia
City
Serdang
State/Province
Selangor
ZIP/Postal Code
43400
Country
Malaysia
12. IPD Sharing Statement
Learn more about this trial
Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
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