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Postprandial Response of Haemostatic Markers and Insulin Sensitivity in Individuals at Risk for Metabolic Syndrome: Role of Dietary Fats and Carbohydrate

This study is currently recruiting participants.
Verified April 2012 by Malaysia Palm Oil Board
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01571947
First received: April 3, 2012
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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. Hence, a randomised, single-blind, crossover design study will be undertaken 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 meal on postprandial lipemia, insulin sensitivity and haemostatic markers in individuals at risk of metabolic syndrome. Fasting blood will be collected and subjects will be instructed to consume test meals within 10 minutes. Further venous blood will be collected at regular intervals for up to 6 hours postprandially. Outcome measures are plasma lipids, insulin response, gut peptides and haemostatic markers. Pro-inflammatory markers [interleukin-6 (IL-6) and interleukin-1β (IL-1β)] will be measured in both plasma and peripheral blood mononuclear cell (PBMC) as exploratory outcomes.


Condition Intervention
Metabolic Syndrome
 Other: Fatty acids and carbohydrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Postprandial Response of Haemostatic Markers and Insulin Sensitivity in Individuals at Risk for Metabolic Syndrome: Role of Dietary Fats and Carbohydrate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:
  • C-peptide [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SFA Other: Fatty acids and carbohydrate
Test meals will be 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.
Experimental: MUFA Other: Fatty acids and carbohydrate
Test meals will be 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.
Experimental: PUFA Other: Fatty acids and carbohydrate
Test meals will be 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.
Experimental: Carb Other: Fatty acids and carbohydrate
Test meals will be 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.

Detailed Description:

A randomized, double-blind, crossover design study will be undertaken 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 meal on postprandial response of insulin sensitivity, haemostatic markers and inflammatory markers in individuals at risk for metabolic syndrome. Volunteers will be asked to participate in four postprandial challenges, separated by at least one week. On the day preceding the postprandial intervention, subjects will be provided a low fat meal to consume as their evening meal. They will be 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 will be collected and subjects will be instructed to consume test meals 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 will be 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).

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571947

Contacts
Contact: Chang Chee Yan +6012-9300186 cyruschang26@gmail.com
Contact: Teng Kim Tiu +603-87694400 ext 4598 kt.teng@gmail.com

Locations
Malaysia
Malaysian Palm Oil Board (MPOB) Recruiting
Kajang, Selangor, Malaysia, 43000
Contact: Chang Chee Yan     +6012-9300186     cyruschang26@gmail.com    
Principal Investigator: Teng Kim Tiu            
Malaysia Palm oil Board Completed
Kajang, Selangor, Malaysia, 43000
Sponsors and Collaborators
Malaysia Palm Oil Board
University of Malaya
  More Information

No publications provided

Responsible Party: Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT01571947     History of Changes
Other Study ID Numbers: A003.11
Study First Received: April 3, 2012
Last Updated: April 4, 2012
Health Authority: Malaysia: Ministry of Health

Keywords provided by Malaysia Palm Oil Board:
Postprandial lipemia
insulin sensitivity
haemostatic markers
inflammatory markers
 gut hormones
dietary fats
carbohydrate
postprandial haemostatic

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hemostatics
Insulin
 Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013