The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers
| Tracking Information | |||||
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| First Received Date ICMJE | May 12, 2010 | ||||
| Last Updated Date | May 14, 2010 | ||||
| Start Date ICMJE | August 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Triacylglycerol (TAG) [ Time Frame: 4 h ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01124487 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Insulin sensitivity (glucose, insulin), non-esterified fatty acids (NEFA), inflammatory markers [ Time Frame: 4 h ] [ 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 | The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers | ||||
| Official Title ICMJE | The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers | ||||
| Brief Summary | Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid profile, insulin sensitivity and inflammatory markers. Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and inflammatory markers postprandially. |
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| Detailed Description | A randomized, single blind, crossover design was undertaken to test meals enriched with palm olein vs olive oil vs lard. Volunteers were asked to participate in three postprandial challenges, separated by at least 3-days. Subjects were provided a low fat meal(<10g fat) the day before the intervention. Fasting blood was collected the next day and the subjects were instructed to consume test meals (50g high fat meal). Further venous blood was collected at 30 min, 1h, 2h, 3h and 4h postprandially. Primary outcome variable: Triacylglycerol (TAG) Secondary outcome variables: Insulin sensitivity (glucose, insulin), non esterified fatty acids (NEFA), inflammatory markers |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE | Lipid Profile | ||||
| Intervention ICMJE | Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Malaysia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01124487 | ||||
| Other Study ID Numbers ICMJE | A001/09 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Kalanithi Nesaretnam, Malaysia Palm Oil Board | ||||
| Study Sponsor ICMJE | Malaysia Palm Oil Board | ||||
| Collaborators ICMJE | University of Malaya | ||||
| Investigators ICMJE |
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| Information Provided By | Malaysia Palm Oil Board | ||||
| Verification Date | May 2010 | ||||
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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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