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Completed

NCT Number: 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

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

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet: Palm olein IV64

Other

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

Other

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

Other

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.

Primary outcomes

  1. Changes of Ratio of total cholesterol to HDL cholesterol (TC:HDL)

    Time frame: week 0 (baseline) and week 4

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

Secondary outcomes

  1. changes of serum HDL cholesterol

    Time frame: week 0 (baseline) and week 4

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  2. changes of serum LDL cholesterol

    Time frame: week 0 (baseline) and week 4

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  3. changes of serum Triacylglycerol (TAG)

    Time frame: week 0 (baseline) and week 4

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  4. changes of serum non-esterified fatty acids (NEFA)

    Time frame: week 0 (baseline) and week 4

    analysed by ELISA kits

  5. changes of serum LDL sub-fractions

    Time frame: week 0 (baseline) and week 4

    analysed with LIPOPRINT System

  6. changes of serum Lp(a)

    Time frame: week 0 (baseline) and week 4

    analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer

  7. changes of Blood pressure

    Time frame: week 0 (baseline) and week 4

    measured by blood pressure meter

  8. Changes of body mass index (BMI)

    Time frame: week 0 (baseline) and week 4

    measured by Tanita Segmental Body Fat Analysis

  9. changes of Waist circumference

    Time frame: week 0 (baseline) and week 4

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • IMU University, Malaysia

Registry information

Acronym: MC1

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2016
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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