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)

June 15, 2016 updated by: Malaysia Palm Oil Board
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
week 0 (baseline) and week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes of serum HDL cholesterol
Time Frame: week 0 (baseline) and week 4
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
week 0 (baseline) and week 4
changes of serum LDL cholesterol
Time Frame: week 0 (baseline) and week 4
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
week 0 (baseline) and week 4
changes of serum Triacylglycerol (TAG)
Time Frame: week 0 (baseline) and week 4
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
week 0 (baseline) and week 4
changes of serum non-esterified fatty acids (NEFA)
Time Frame: week 0 (baseline) and week 4
analysed by ELISA kits
week 0 (baseline) and week 4
changes of serum LDL sub-fractions
Time Frame: week 0 (baseline) and week 4
analysed with LIPOPRINT System
week 0 (baseline) and week 4
changes of serum Lp(a)
Time Frame: week 0 (baseline) and week 4
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
week 0 (baseline) and week 4
changes of Blood pressure
Time Frame: week 0 (baseline) and week 4
measured by blood pressure meter
week 0 (baseline) and week 4
Changes of body mass index (BMI)
Time Frame: week 0 (baseline) and week 4
measured by Tanita Segmental Body Fat Analysis
week 0 (baseline) and week 4
changes of Waist circumference
Time Frame: week 0 (baseline) and week 4
week 0 (baseline) and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Malaysia Palm Oil Board

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
International Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PD205/15- STUDY 1 (A)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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