Clinical trial NCT02802904: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Healthy subjects
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: International Medical University
First posted: 2016-06-16
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Changes of Ratio of total cholesterol to HDL cholesterol (TC:HDL)
timeFrame: week 0 (baseline) and week 4
Secondary outcomes:
measure: changes of serum HDL cholesterol
timeFrame: week 0 (baseline) and week 4
measure: changes of serum LDL cholesterol
timeFrame: week 0 (baseline) and week 4
measure: changes of serum Triacylglycerol (TAG)
timeFrame: week 0 (baseline) and week 4
measure: changes of serum non-esterified fatty acids (NEFA)
timeFrame: week 0 (baseline) and week 4
measure: changes of serum LDL sub-fractions
timeFrame: week 0 (baseline) and week 4
measure: changes of serum Lp(a)
timeFrame: week 0 (baseline) and week 4
measure: changes of Blood pressure
timeFrame: week 0 (baseline) and week 4
measure: Changes of body mass index (BMI)
timeFrame: week 0 (baseline) and week 4
measure: changes of Waist circumference
timeFrame: week 0 (baseline) and week 4
Other outcomes:
Locations:
Study officials:
affiliation: MPOB
name: Datuk Dr. Choo Yuen May, PhD
role: STUDY_CHAIR
affiliation: Malaysian Oil Scientists and Technologists' Association (MOSTA)
name: Emeritus Prof. Datuk Dr. Augustine Ong Soon Hock, PhD
role: STUDY_CHAIR
affiliation: IMU
name: Assoc Prof Dr Tony Ng Kock Wai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MPOB
name: Dr Kanga Rani Selvaduray, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MPOB
name: Radhika Loganathan, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: MPOB
name: Dr Darren Gouk Siew Wah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MPOB
name: Gowri Nagapan, MSc
role: PRINCIPAL_INVESTIGATOR
References: