Postprandial Response of Haemostatic Markers and Insulin Sensitivity in Individuals at Risk for Metabolic Syndrome: Role of Dietary Fats and Carbohydrate
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 3, 2012 | ||||||||
| Last Updated Date | April 4, 2012 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
C-peptide [ Time Frame: 5 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01571947 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Insulin [ Time Frame: 5 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Postprandial Response of Haemostatic Markers and Insulin Sensitivity in Individuals at Risk for Metabolic Syndrome: Role of Dietary Fats and Carbohydrate | ||||||||
| Official Title ICMJE | Postprandial Response of Haemostatic Markers and Insulin Sensitivity in Individuals at Risk for Metabolic Syndrome: Role of Dietary Fats and Carbohydrate | ||||||||
| 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. 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. |
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| 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). |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Metabolic Syndrome | ||||||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Malaysia | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01571947 | ||||||||
| Other Study ID Numbers ICMJE | A003.11 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Malaysia Palm Oil Board | ||||||||
| Study Sponsor ICMJE | Malaysia Palm Oil Board | ||||||||
| Collaborators ICMJE | University of Malaya | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Malaysia Palm Oil Board | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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