Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
1 other identifier
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedJuly 16, 2014
July 1, 2014
1.5 years
June 24, 2014
July 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in serum C-peptide level of subject
up to 8 weeks
Secondary Outcomes (5)
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
Study Arms (3)
palm olein margarine
EXPERIMENTAL8 weeks
IE palm olein margarine
EXPERIMENTAL8 weeks
IE soybean oil-based margarine
EXPERIMENTAL8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Malaysia Palm Oil Boardlead
- IMU University, Malaysiacollaborator
- Universiti Putra Malaysiacollaborator
Study Sites (1)
University Putra Malaysia
Serdang, Selangor, 43400, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Voon Phooi Tee, Ph.D
MPOB
- PRINCIPAL INVESTIGATOR
Ng Yen Teng, BSc
IMU
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2014
First Posted
July 16, 2014
Study Start
September 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
July 16, 2014
Record last verified: 2014-07