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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

23

Phase

  • 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

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
Intervention / Treatment
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

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

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

Malaysia Palm Oil Board

Collaborators

Universiti Putra Malaysia
Ministry of Health, Malaysia

Investigators

  • 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

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

September 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (ESTIMATE)

July 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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