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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Acute Effects of Fats and Carbohydrate
Sponsored by
Malaysia Palm Oil Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Insulinaemia, inflammatory markers, gastrointestinal peptides, SFA, dietary fats, carbohydrate, insulin sensitivity

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Malaysia Palm oil Board
  • Malaysian Palm Oil Board (MPOB)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

SFA

MUFA

PUFA

CARB

Arm Description

Outcomes

Primary Outcome Measures

C-peptide

Secondary Outcome Measures

Insulin

Full Information

First Posted
April 3, 2012
Last Updated
July 22, 2014
Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01571947
Brief Title
Acute Effects of Dietary Fats and Carbohydrate in Subjects With Metabolic Syndrome
Official Title
Acute Effects of Dietary Fats and Carbohydrate on Insulinaemia, Lipaemia, Inflammatory Responses and Gastrointestinal Peptide Secretion in Subjects With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Insulinaemia, inflammatory markers, gastrointestinal peptides, SFA, dietary fats, carbohydrate, insulin sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SFA
Arm Type
Active Comparator
Arm Title
MUFA
Arm Type
Active Comparator
Arm Title
PUFA
Arm Type
Active Comparator
Arm Title
CARB
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Acute Effects of Fats and Carbohydrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
C-peptide
Time Frame
6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)
Secondary Outcome Measure Information:
Title
Insulin
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim-Tiu Teng, PhD
Organizational Affiliation
Malaysia Palm Oil Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaysia Palm oil Board
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Malaysian Palm Oil Board (MPOB)
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
27632019
Citation
Chang CY, Kanthimathi MS, Tan AT, Nesaretnam K, Teng KT. The amount and types of fatty acids acutely affect insulin, glycemic and gastrointestinal peptide responses but not satiety in metabolic syndrome subjects. Eur J Nutr. 2018 Feb;57(1):179-190. doi: 10.1007/s00394-016-1307-9. Epub 2016 Sep 8.
Results Reference
derived
PubMed Identifier
26232169
Citation
Teng KT, Chang CY, Kanthimathi MS, Tan AT, Nesaretnam K. Effects of amount and type of dietary fats on postprandial lipemia and thrombogenic markers in individuals with metabolic syndrome. Atherosclerosis. 2015 Sep;242(1):281-7. doi: 10.1016/j.atherosclerosis.2015.07.003. Epub 2015 Jul 7.
Results Reference
derived

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

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