Effects of Medium-Chain Triglycerides on Chylomicron Secretion and Expression of Genes That Regulate Intestinal Lipid Metabolism in Men With Dyslipidemia Associated With the Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

— MCT  

Official title:

Effects of Medium-Chain Triglycerides on Chylomicron Secretion and Expression of Genes That Regulate Intestinal Lipid Metabolism in Men With Dyslipidemia Associated With the Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806142
• Other study ID #: INAF-C10-08-053
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: March 6, 2013
• Start date: February 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Several lines of evidence indicate that a significant proportion of cardiovascular disease (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and perturbations, defined as the metabolic syndrome. It has been estimated that approximately 25% of the North American adult population is living with the metabolic syndrome. Recent studies from the investigators group show that overaccumulation of atherogenic triglyceride-rich lipoproteins (TRL) seen in insulin-resistant patients is partly due to increased production rate of intestinally derived apolipoprotein (apo) B-48-containing lipoproteins. This is of interest because substantial evidence exists indicating that elevated levels of intestinal lipoproteins are associated with increased CVD risk. In this regard, there is some evidence that medium-chain triglycerides (MCTs) may beneficially modify lipoprotein metabolism in hypertriglyceridemic patients. However, as emphasized in the body of this grant proposal, the specific impact of MCTs on the intestinal lipoprotein secretion and on expression of genes that regulate intestinal lipid absorption and chylomicron synthesis has not yet been investigated in humans.

The general objective of the proposed research is to investigate the mechanisms by which MCTs beneficially modify intestinal lipoprotein metabolism in patients with the metabolic syndrome. The primary hypothesis is that MCT supplementation will decrease plasma levels of intestinal lipoproteins by reducing secretion of these particles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Men aged between 18-60 years

• Waist circumference > 102 cm

• HDL-cholesterol < 1.1 mmol/L

• Triglycerides > 1.7 mmol/L

• Fasting blood glucose > 6.1 mmol/L

• Normal blood pressure (<130/85)

Exclusion Criteria:

• Women

• Men < 18 or > 60 years

• Smokers (> 1 cigarette/day)

• Body weight variation > 10% during the last 6 months prior to the study baseline

• Subjects with a previous history of cardiovascular disease

• Subjects with type 2 diabetes

• Subjects with a monogenic dyslipidemia

• Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa

• Subjects with endocrine or gastrointestinal disorders

• History of alcohol or drug abuse within the past 2 years

• Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyslipidemias
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Medium-chain triglycerides
During Medium-Chain Triglycerides (MCT period), participant will asked to consume two pastries per day that will provide a total of 20 g of MCT/day for 4 weeks.
• Corn oil
During Corn oil period (Control period), participant will asked to consume two pastries per day that will provide a total of 20 g of corn oil/day for 4 weeks.

Locations

Country	Name	City	State
Canada	Institute of Nutrition and Functional Foods (INAF)	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TRL apolipoprotein B48 (apoB-48) production rate.		At week 4 and week 10 (at the end of the two 4-weeks supplementation).	No
Secondary	Changes in duodenal expression of genes that regulate intestinal lipid absorption.	Genes that regulate intestinal lipid absorption that will be measured are Niemann-Pick C1-like 1 (NPC1L1), Adenosine triphosphate(ATP)-binding cassette transporters (ABCG5/8), Fatty Acid Binding Protein (FABP), Sterol Regulatory Element Binding Protein (SREBP-1c).	At week 4 and week 10 (at the end of the two 4-weeks supplementation).	No
Secondary	Changes in duodenal expression of genes that regulate intestinal lipid synthesis.	Genes that regulate intestinal lipid synthesis that will be measured are Acyl-Coenzyme A(CoA):diacylglycerol acyltransferase (DGAT), Acyl-CoA:cholesterol O-acyltransferase 2 (ACAT2) and 3-hydroxy-methylglutaryl-CoA reductase (HMG CoA reductase).	At week 4 and week 10 (at the end of the two 4-weeks supplementation).	No
Secondary	Change in synthesis of apoB-48 containing lipoproteins (Microsomal triglyceride transfer protein (MTP), apoB-48).		At week 4 and week 10 (at the end of the two 4-weeks supplementation).	No