Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers

Study Overview
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Brief Summary
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Fats and oils are made up of >90% triacylglycerol fat molecules which consist of a glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid attachment are referred to by stereospecific numbers, sn -1, -2 and -3. There is existing evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with predominantly palmitic acid (16:0) or stearic acid (18:0) in the sn-1 and sn-3 positions of fat molecules do not raise serum cholesterol levels. These observations have come to be known as or explained by the sn-2 hypothesis. New evidence have also emerged to show that saturated fatty acids (16:0, 18:0) in the sn-1 and -3 positions reduces fat deposition in a rat model. In this proposed study, the effects on the outcome measures investigated of three test fats [namely palm olein IV64 (POP), virgin olive oil (OOO) and cocoa butter (POS)], with oleic acid primarily at the sn-2 position but differing amounts of palmitic, stearic and oleic acids at the sn-1/sn-3 positions of the triglyceride molecule, are investigated

Detailed Description
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To investigate the effects of different dietary fats with primarily oleic acid in the sn-2 position on the cardiovascular risk profile in healthy Malaysian volunteers

Official Title
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Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Diet: Palm olein IV64
* Other: Diet: Cocoa butter
* Other: Diet: Virgin olive oil


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy adult male or female, aged 20-50 years BMI 18.5- 24.9 kg/m2 as per WHO Classification (1998) Exclusion criteria: Hyperlipidemia (TC>6.2 mmol/L, TAG >2.0 mmol/L) History of chronic disease- type 2 DM, heart disease, cancer Habitual smokers (>2 sticks a day) Hypertensives: >140/90 mmHg On medication/nutraceuticals to reduce blood lipids, blood pressure Pregnant or lactating women Planned trip abroad/overseas during period of study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palm olein IV 64<br>Palm olein IV 64, n= 15, 4 weeks intervention | Other: Diet: Palm olein IV64<br>* Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat Palm Olein IV64 which was incorporated into daily snacks ( 50g of test fats, brownies ( 15g test fat each) for breakfast and 4 pieces cookies ( 5g test fat each) with low fat palm olein based background diet daily.<br>|
| Experimental: Cocoa butter<br>Cocoa butter, n= 15, 4 weeks intervention | Other: Diet: Cocoa butter<br>* Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat cocoa butter which was incorporated into daily snacks ( 50g of test fats, brownies ( 15g test fat each) for breakfast and 4 pieces cookies ( 5g test fat each) with low fat palm olein based background diet daily.<br>|
| Experimental: Virgin olive oil<br>Virgin olive oil, n= 15, 4 weeks intervention | Other: Diet: Virgin olive oil<br>* Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat virgin olive oil which incorporated into daily snacks ( 50g of test fats, brownies ( 15g test fat each) for breakfast and 4 pieces cookies ( 5g test fat each) with low fat palm olein based background diet daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Ratio of total cholesterol to HDL cholesterol (TC:HDL) | analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer | week 0 (baseline) and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of serum HDL cholesterol | analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer | week 0 (baseline) and week 4 | 
| changes of serum LDL cholesterol | analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer | week 0 (baseline) and week 4 | 
| changes of serum Triacylglycerol (TAG) | analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer | week 0 (baseline) and week 4 | 
| changes of serum non-esterified fatty acids (NEFA) | analysed by ELISA kits | week 0 (baseline) and week 4 | 
| changes of serum LDL sub-fractions | analysed with LIPOPRINT System | week 0 (baseline) and week 4 | 
| changes of serum Lp(a) | analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer | week 0 (baseline) and week 4 | 
| changes of Blood pressure | measured by blood pressure meter | week 0 (baseline) and week 4 | 
| Changes of body mass index (BMI) | measured by Tanita Segmental Body Fat Analysis | week 0 (baseline) and week 4 | 
| changes of Waist circumference |  | week 0 (baseline) and week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy subjects