Effects of Triacylglycerol Structure on Gut Hormones and Haemostatic Markers

October 9, 2015 updated by: Malaysia Palm Oil Board

The Acute Effects of Triacylglycerol Structure of Dietary Fats on Gut Hormones and Haemostatic Markers in Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (T2DM) is a chronic disorder determined by lifestyle and genes. It is associated with chronic hyperglycaemia along with other metabolic abnormalities. It is also one of the risk factors for cardiovascular disease (CVD). This disease is due to insulin resistance and/or deficiency as well as increased hepatic glucose output. According to the Third National Health and Morbidity Survey (3rd NHMS), the prevalence of T2DM for adults aged 30 years and above is 14.9%, increased by almost 80% from 1996 to 2006. Dietary composition may affect insulin sensitivity, postprandial triacylglycerol concentration and the risk of T2DM. The role of dietary fats in T2DM is of particular interest and has been clinically studied for many decades. The type of fat we ingest every day consists of different types of fatty acids and different degree of saturation, which in turn influence glucose metabolism by altering cell membrane function, enzyme activity, insulin signalling and gene expression. Previous studies demonstrated that interesterification of dietary fat alter postprandial lipaemia. Saturated fat such as palm olein has been reported to display lower postprandial lipaemia after interesterification. Changing the structure of triacylglycerol (TAG) alters the physical properties of dietary fat which affects digestibility, metabolism and atherogenicity. A recent study conducted by Sanders and co-workers demonstrated reduced levels of plasma glucose-dependent insulinotropic polypeptide (GIP) following both the lard and interesterified palm olein (IPO) compared with the palm olein (PO) and high oleic sunflower oil (HOS) diets in healthy subjects. The GIP and glucagon-like peptide-1 (GLP-1) are major players in the modulation of postprandial insulin secretion by the pancreas. Although GIP secretion in response to meals is normal in patients with Type 2 diabetes mellitus (T2DM), GIP induced secretion of insulin is defective in diabetes. This is observed to be predominantly a defective stimulation of the late phase of insulin response (20-120 minutes). The effect of IPO on GIP may be exaggerated in T2DM patients with impaired insulin sensitivity. Hence, IPO may change the concentrations of gut hormones, postprandial lipaemia, insulinaemic response and CVD related haemostatic markers.

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

Subjects aged between 30 and 60 years old (male and female) with Type 2 diabetes mellitus (T2DM) will be recruited for this study. A randomized, crossover, double-blind study design will be carried out to investigate the acute effects of high fat meals prepared using palm olein (PO), chemically interesterified palm olein (IPO) and high oleic sunflower oil (HOS) (control) on study subjects with T2DM. Study subjects will have to undergo three postprandial challenges, separated by at least one week interval. Fasting blood sample and duplicate baseline blood samples will be taken in the morning of postprandial day. After that, subjects will be asked to consume a test meal consisting a high fat muffin baked using the aforementioned oils and a milkshake within 10 minutes. After meal, venous blood samples will be taken at time-points 15, 30, 60, 90, 120 min, 3 h, 4 h, 5 h, 6 h and post-heparin plasma 5 min and 15 min for analysis. Pulse wave analysis will be conducted to evaluate central blood pressure and arterial stiffness. Meal appreciation will be assessed by utilising visual analogue scale (VAS) before eating, after eating and at each time-point.

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.
23

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Malaysian Palm Oil Board (MPOB)
      • Kajang, Selangor, Malaysia, 43100
        • Hulu Langat District Health Office
      • Sepang, Selangor, Malaysia, 43900
        • Sepang District Health Office
      • Serdang, Selangor, Malaysia, 43400
        • Universiti Putra Malaysia
      • Shah Alam, Selangor, Malaysia, 40100
        • Selangor State Health Office

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

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Mild T2DM individuals not planned for medical intervention

    • 7.0 mmol/L ≤ fasting glucose ≤ 11.1 mmol/L
    • 6.5% ≤ HbA1c ≤ 9.0%
    • Not using antihypertensive, lipid lowering, insulin/glucose modulating medication

  2. Mild T2DM individuals currently on medical intervention

    • Fasting glucose ≤ 11.1 mmol/L
    • HbA1c ≤ 9.0%
    • Using antihypertensive, lipid lowering or glucose modulating medication
  3. Malaysian male or female with T2DM aged between 30 to 60 years old
  4. Not using insulin
  5. Not having any complications of diabetes
  6. No medical history of myocardial infarction, angina, thrombosis, stroke or cancer
  7. Haemoglobin levels for females ≥ 11.5 gm/dl and males ≥ 12.5 gm/dl
  8. Serum ferritin > 15 µg/l at commencement of study

Exclusion Criteria:

  1. Medical history of myocardial infarction, angina, thrombosis, stroke or cancer
  2. Underweight (BMI < 18.5 kg/m²)
  3. Using insulin
  4. Total cholesterol > 7.0 mmol/L
  5. Abnormal liver function, renal function and haematology
  6. Hypersensitive towards heparin
  7. Gastric or lactose intolerance
  8. Smoker
  9. Pregnancy and lactating
  10. Taking alcohol
  11. Taking alcohol
  12. Haemoglobin levels for females ≤ 11.5 gm/dl and males ≤ 12.5 gm/dl
  13. Serum ferritin < 15 µg/l at commencement 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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

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: Dietary fat - PO
Native palm olein (IV56)
Other: Native palm olein (IV56)
Test meal consists of a high fat muffin (containing 50 g native palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day.
Other Names:
  • PO
EXPERIMENTAL: Dietary fat - IPO
Chemically interesterified palm olein (IV56)
Other: Chemically interesterified palm olein (IV56)
Test meal consists of a high fat muffin (containing 50 g chemically interesterified palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day.
Other Names:
  • IPO
EXPERIMENTAL: Dietary fat - HOS
High oleic sunflower oil
Other: High oleic sunflower oil
Test meal consists of a high fat muffin (containing 50 g high oleic sunflower oil) and a cup of milkshake, to be taken as breakfast for each postprandial study day.
Other Names:
  • HOS

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
6-hour postprandial changes from fasting in glucose-dependent insulinotropic polypeptide (GIP)
Time Frame: 0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour
To determine the postprandial changes of GIP.
0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour

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
6-hour postprandial changes from fasting in gut hormones
Time Frame: 0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 h
To determine the postprandial changes of ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY) and cholecystokinin (CCK).
0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 h
6-hour postprandial changes from fasting in insulinaemic response
Time Frame: 0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour
To determine the postprandial changes of glucose, insulin, C-peptide and non-esterified fatty acid (NEFA)
0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour
6-hour postprandial changes from fasting in lipaemia
Time Frame: 0, 1, 2, 3, 4, 5, 6 hour for TAG and apoB48; 6 hour postheparin for LPL; pooled 3, 4, 5 hour for chylomicron and PFA

To determine the postprandial changes of triacylglycerol (TAG) and apolipoprotein B48 (apoB48).

To compare lipoprotein lipase (LPL) activity, chylomicron fatty acid composition and plasma fatty acid (PFA) composition across meals.
0, 1, 2, 3, 4, 5, 6 hour for TAG and apoB48; 6 hour postheparin for LPL; pooled 3, 4, 5 hour for chylomicron and PFA
6-hour postprandial changes from fasting in haemostatic response
Time Frame: 0, 2, 4, 6 hour for FVIIa, PAI-1 and D-dimer; 0, 4 hour for PWA

To determine the postprandial changes of factor FVII activation (FVIIa), plasminogen activator inhibitor-1 (PAI-1)and D-dimer.

To compare pulse wave analysis (PWA) across meals.
0, 2, 4, 6 hour for FVIIa, PAI-1 and D-dimer; 0, 4 hour for PWA
6-hour changes from fasting hunger rating using visual analogue scale (VAS)
Time Frame: 0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour
To determine the changes in hunger rating and food satiety
0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour

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.
Universiti Putra Malaysia
Ministry of Health, Malaysia

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.
  • Principal Investigator: Kim Tiu Teng, PhD, Malaysian Palm Oil Board (MPOB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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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.
September 1, 2012

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.
July 1, 2013

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.
March 1, 2014

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).
July 11, 2013

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.
July 19, 2013

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.
July 24, 2013

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.
October 12, 2015

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.
October 9, 2015

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.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • A005/11
  • NMRR-12-146-11363 (REGISTRY: National Medical Research Register)

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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