Acute Effects of Dietary Fats and Carbohydrate in Subjects With Metabolic Syndrome

July 22, 2014 updated by: Malaysia Palm Oil Board

Acute Effects of Dietary Fats and Carbohydrate on Insulinaemia, Lipaemia, Inflammatory Responses and Gastrointestinal Peptide Secretion in Subjects With Metabolic Syndrome

There is increasing evidence suggests that elevated levels of postprandial triacylglycerol (TAG)-rich lipoproteins may promote the development of cardiovascular diseases (CVD). A prolonged and elevated postprandial lipemia is associated with increased risk of CVD by a variety of mechanisms such as insulin resistance, inflammation, endothelial dysfunction and oxidative stress. However, current evidence on the acute effects of type of fats on postprandial insulinaemia, gastrointestinal peptide secretion, inflammatory response, as well as satiation are limited and inconsistent, in particular in metabolic syndrome population in Asian. Hence, this study aimed to investigate the postprandial effects of high fat meals enriched with i) palm olein, ii) high oleic sunflower oil, and iii) high linoleic sunflower oil, compared with a low fat/high carbohydrate meal, in 30 subjects with metabolic syndrome.

Study Overview

Status

Completed

Conditions

Detailed Description

A randomized, double-blind, crossover design study was conducted to test the acute effects of high fat meals enriched with (1) saturated fatty acids (SFA); (2) monounsaturated fatty acids (MUFA); (3) polyunsaturated fatty acids (PUFA) vs. (4) a low fat/high carbohydrate (CARB) meal on postprandial insulinaemic, lipaemic and inflammatory responses, as well as gastrointestinal peptide secretion and satiation on 30 metabolic syndrome subjects (15 men and 15 women). Primary outcome of this study is postprandial changes of C-peptide. Other measured outcomes including insulin and glucose responses, lipids, cytokines and gastrointestinal peptides. Subjective appetite measurements were taken as exploratory outcomes using visual analogue scales.

Subjects were asked to participate in four postprandial challenges, separated by at least one week. On the day preceding the postprandial intervention, subjects were provided a low fat meal (< 10 g) to consume as their evening meal. They were required to fast over night after 10 pm and arrive at the research unit at 7:30 am - 9:00 am the following morning. Fasting blood samples were collected and subjects were instructed to consume the allocated test meal within 10 minutes. Further venous blood will be collected at regular intervals for up to 6 hours postprandially. During the 6 hours of the experimental study, the subjects were refrained from the consumption of any food or drink except plain water which they will be asked to consume at regular intervals (up to 750 mL over the 6 hours).

Study Type

Interventional

Enrollment (Actual)

30

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

    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Malaysia Palm Oil Board
      • Kajang, Selangor, Malaysia, 43000
        • Malaysian Palm Oil Board (MPOB)

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

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20 - 60
  • Elevated TAG with at least 1.7 mmol/L
  • Low HDL cholesterol (< 1.04 mmol/L for men, 1.3 mmol/L for women)
  • Elevated blood pressure (systolic at least 130, diastolic at least 85 mmHg)
  • Increased waist circumference (at least 90cm for men, 80cm for women)
  • Fasting plasma glucose between 5.6 and 7.0 mmol/L

Exclusion Criteria:

  • Underweight
  • Current use of antihypertensive or lipid lowering medication
  • Alcohol intake exceeding a moderate intake (> 28 units per week)
  • Medical history of myocardial infarction, angina, thrombosis, stroke, cancer or diabetes
  • Pregnancy or breast-feeding
  • Smoker

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SFA
Test meals were served in the form of muffin + milkshake. For high fat meals, 55g of test fat will be incorporated in muffins, whereas 22g of fat for low fat or high carbohydrate test meal. During study day, subjects were to consume the allocated test meal within 10 minutes.
Active Comparator: MUFA
Test meals were served in the form of muffin + milkshake. For high fat meals, 55g of test fat will be incorporated in muffins, whereas 22g of fat for low fat or high carbohydrate test meal. During study day, subjects were to consume the allocated test meal within 10 minutes.
Active Comparator: PUFA
Test meals were served in the form of muffin + milkshake. For high fat meals, 55g of test fat will be incorporated in muffins, whereas 22g of fat for low fat or high carbohydrate test meal. During study day, subjects were to consume the allocated test meal within 10 minutes.
Active Comparator: CARB
Test meals were served in the form of muffin + milkshake. For high fat meals, 55g of test fat will be incorporated in muffins, whereas 22g of fat for low fat or high carbohydrate test meal. During study day, subjects were to consume the allocated test meal within 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
C-peptide
Time Frame: 6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)
6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin
Time Frame: 6 hours
6 hours

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Kim-Tiu Teng, PhD, Malaysia Palm Oil Board

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.

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

November 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Estimate)

July 23, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

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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