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

Cardiovascular Risk Factor Clinical Trial

— MC1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802904
• Other study ID #: PD205/15- STUDY 1 (A)
• Status: Completed
• Phase: N/A
• First received: June 2, 2016
• Last updated: June 15, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: International Medical University
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	International Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	changes of serum HDL cholesterol	analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer	week 0 (baseline) and week 4	No
Secondary	changes of serum LDL cholesterol	analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer	week 0 (baseline) and week 4	No
Secondary	changes of serum Triacylglycerol (TAG)	analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer	week 0 (baseline) and week 4	No
Secondary	changes of serum non-esterified fatty acids (NEFA)	analysed by ELISA kits	week 0 (baseline) and week 4	No
Secondary	changes of serum LDL sub-fractions	analysed with LIPOPRINT System	week 0 (baseline) and week 4	No
Secondary	changes of serum Lp(a)	analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer	week 0 (baseline) and week 4	No
Secondary	changes of Blood pressure	measured by blood pressure meter	week 0 (baseline) and week 4	No
Secondary	Changes of body mass index (BMI)	measured by Tanita Segmental Body Fat Analysis	week 0 (baseline) and week 4	No
Secondary	changes of Waist circumference		week 0 (baseline) and week 4	No