NCT01806142

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

1.2 years

First QC Date

March 5, 2013

Last Update Submit

March 6, 2013

Conditions

Metabolic Syndrome X

Outcome Measures

Primary Outcomes (1)

  • Change in TRL apolipoprotein B48 (apoB-48) production rate.

    At week 4 and week 10 (at the end of the two 4-weeks supplementation).

Secondary Outcomes (3)

  • Changes in duodenal expression of genes that regulate intestinal lipid absorption.

    At week 4 and week 10 (at the end of the two 4-weeks supplementation).

  • Changes in duodenal expression of genes that regulate intestinal lipid synthesis.

    At week 4 and week 10 (at the end of the two 4-weeks supplementation).

  • 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).

Study Arms (2)

Medium-chain triglycerides

EXPERIMENTAL

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.

Other: Medium-chain triglycerides

Corn oil

ACTIVE COMPARATOR

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.

Other: Corn oil

Interventions

Medium-chain triglyceridesOTHER

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.

Medium-chain triglycerides
Corn oilOTHER

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.

Corn oil

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition and Functional Foods (INAF)

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

  • Tremblay AJ, Lamarche B, Labonte ME, Lepine MC, Lemelin V, Couture P. Dietary medium-chain triglyceride supplementation has no effect on apolipoprotein B-48 and apolipoprotein B-100 kinetics in insulin-resistant men. Am J Clin Nutr. 2014 Jan;99(1):54-61. doi: 10.3945/ajcn.113.068767. Epub 2013 Oct 30.

    PMID: 24172309DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Corn Oil

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Patrick Couture, MD,FRCP,PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCP, PhD

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 7, 2013

Study Start

February 1, 2011

Primary Completion

April 1, 2012

Study Completion

February 1, 2013

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

CA(1)