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 (MC1)

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Other: Diet: Palm olein IV64; Other: Diet: Cocoa butter; Other: Diet: Virgin olive oil

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palm olein IV 64; Palm olein IV 64, n= 15, 4 weeks intervention	Other: Diet: Palm olein IV64; 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.
Experimental: Cocoa butter; Cocoa butter, n= 15, 4 weeks intervention	Other: Diet: Cocoa butter; 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.
Experimental: Virgin olive oil; Virgin olive oil, n= 15, 4 weeks intervention	Other: Diet: Virgin olive oil; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Malaysia Palm Oil Board
• Collaborators: International Medical University
• Investigators: Study Chair: Datuk Dr. Choo Yuen May, PhD, MPOB; Study Chair: Emeritus Prof. Datuk Dr. Augustine Ong Soon Hock, PhD, Malaysian Oil Scientists and Technologists' Association (MOSTA); Principal Investigator: Assoc Prof Dr Tony Ng Kock Wai, PhD, IMU; Principal Investigator: Dr Kanga Rani Selvaduray, PhD, MPOB; Principal Investigator: Radhika Loganathan, MSc, MPOB; Principal Investigator: Dr Darren Gouk Siew Wah, PhD, MPOB; Principal Investigator: Gowri Nagapan, MSc, MPOB

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Healthy subjects
• Other Study ID Numbers: PD205/15- STUDY 1 (A)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided