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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02802904
Acronym
MC1
Enrollment
42
Registered
2016-06-16
Start date
2016-01-31
Completion date
2016-06-30
Last updated
2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor

Keywords

Healthy subjects

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

Interventions

OTHERDiet: 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.

OTHERDiet: 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.

OTHERDiet: 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.

Sponsors

IMU University, Malaysia
CollaboratorOTHER
Malaysia Palm Oil Board
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes of Ratio of total cholesterol to HDL cholesterol (TC:HDL)week 0 (baseline) and week 4analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

Secondary

MeasureTime frameDescription
changes of serum HDL cholesterolweek 0 (baseline) and week 4analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
changes of serum LDL cholesterolweek 0 (baseline) and week 4analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
changes of serum Triacylglycerol (TAG)week 0 (baseline) and week 4analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
changes of serum non-esterified fatty acids (NEFA)week 0 (baseline) and week 4analysed by ELISA kits
changes of serum LDL sub-fractionsweek 0 (baseline) and week 4analysed with LIPOPRINT System
changes of Blood pressureweek 0 (baseline) and week 4measured by blood pressure meter
Changes of body mass index (BMI)week 0 (baseline) and week 4measured by Tanita Segmental Body Fat Analysis
changes of Waist circumferenceweek 0 (baseline) and week 4
changes of serum Lp(a)week 0 (baseline) and week 4analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026