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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Malaysia Palm Oil Board.
Recruitment status was  Recruiting
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

April 3, 2012
April 4, 2012
November 2011
June 2012   (final data collection date for primary outcome measure)
C-peptide [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01571947 on ClinicalTrials.gov Archive Site
Insulin [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Postprandial Response of Haemostatic Markers and Insulin Sensitivity in Individuals at Risk for Metabolic Syndrome: Role of Dietary Fats and Carbohydrate
Postprandial Response of Haemostatic Markers and Insulin Sensitivity in Individuals at Risk for Metabolic Syndrome: Role of Dietary Fats and Carbohydrate

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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Metabolic Syndrome
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: SFA
    Intervention: Other: Fatty acids and carbohydrate
  • Experimental: MUFA
    Intervention: Other: Fatty acids and carbohydrate
  • Experimental: PUFA
    Intervention: Other: Fatty acids and carbohydrate
  • Experimental: Carb
    Intervention: Other: Fatty acids and carbohydrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact: Chang Chee Yan +6012-9300186 cyruschang26@gmail.com
Contact: Teng Kim Tiu +603-87694400 ext 4598 kt.teng@gmail.com
Malaysia
 
NCT01571947
A003.11
Yes
Malaysia Palm Oil Board
Malaysia Palm Oil Board
University of Malaya
Not Provided
Malaysia Palm Oil Board
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP