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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02192047 |
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Date of registration:
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24/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
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Scientific title:
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Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD) |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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85 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02192047 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Voon Phooi Tee, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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MPOB |
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Name:
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Ng Yen Teng, BSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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IMU |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overweight
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Intervention(s)
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Other: IE Palm olein
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Other: Palm Olein
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Other: IE soybean oil-based
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Primary Outcome(s)
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Change in serum C-peptide level of subject
[Time Frame: up to 8 weeks]
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Secondary Outcome(s)
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Change in serum lipid profile
[Time Frame: up to 8 weeks]
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Change in markers of obesity
[Time Frame: up to 8 weeks]
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Change in markers of inflammation
[Time Frame: up to 8 weeks]
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Oral Glucose tolerance test (OGTT)
[Time Frame: Baseline, month-2]
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Change in markers of insulin resistance
[Time Frame: up to 8 weeks]
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Secondary ID(s)
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PD 174/13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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