Effects of Macronutrients on Hepatic Lipids, Plasma Triglycerides, and Insulin Sensitivity (MACRONUTR)

June 12, 2018 updated by: Luc Tappy, MD, University of Lausanne

Study of the Role of Insulin Resistance in the Pathogenesis of the Metabolic Syndrome and of Non-alcoholic Steatohepatitis

The purpose of this study is to assess how the macronutrient composition of the diet effects

  • lipid and glucose metabolism
  • intrahepatic lipids
  • insulin sensitivity

in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and offsprings of patients with type 2 diabetes mellitus).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is aimed at assessing the effects of changes in total energy, sugars, lipids, and protein intake on intrahepatic lipids, plasma lipids, and hepatic and whole body insulin resistance in

  • lean men and women with no family history of diabetes
  • overweight men and women
  • lean men with a family history of type 2 diabetes

Subjects are studied after a 6-day period of

  • isocaloric diet with 100% calorie requirement, of which 55% carbohydrate, 15% protein, and 30% fat)
  • the same isocaloric diet supplemented with 3g/kg body weight/day fructose
  • hypercaloric high fat diet with 130% energy requirement, of which 55% carbohydrate, 15% protein, 60% fat
  • hypercaloric high fat+protein diet with 145% energy requirement, of which 55% carbohydrate, 30% protein, 60% fat

Measurements performed after 6 days on each diet include

  • intrahepatic and intramyocellular lipids (1H-MRS)
  • hepatic and whole body insulin sensitivity (hyperinsulinemic-euglycemic clamp)
  • body weight
  • plasma concentrations of hormones and substrates
  • gene expression profile in skeletal muscle (vastus lateralis) and adipose tissue (subcutaneous abdominal)

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females
  • Age 18-40
  • Informed consent obtained
  • Subgroup with overweight (body mass index [BMI] > 25)
  • Subgroup with family history of type 2 diabetes mellitus

Exclusion Criteria:

  • Smokers
  • Alcohol intake > 30g/day
  • Drug abuse
  • Diabetes mellitus
  • Any concurrent medication
  • Having a pacemaker
  • History of orthopedic surgery
  • History of metal foreign bodies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: normal weight male high fructose diet
Effects of diet intervention " high fructose" in normal weight subjects
Other: diet intervention
controlled hypercaloric high fructose, high fat, or high fat/high protein diet
Experimental: offsprings of T2DM high fructose diet
Effect of diet intervention "high fructose" in healthy non-obese offsprings of patients with type 2 diabetes
Other: diet intervention
controlled hypercaloric high fructose, high fat, or high fat/high protein diet
Experimental: normal weight subjects high fat diet
effects of diet intervention "high fat" in healthy male subjects
Other: diet intervention
controlled hypercaloric high fructose, high fat, or high fat/high protein diet
Experimental: Normal weight high fat+protein diet
effect of diet intervention "high fat + protein" subjects in healthy male subjects
Other: diet intervention
controlled hypercaloric high fructose, high fat, or high fat/high protein diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma triglycerides
Time Frame: 6 days
6 days
intra-hepatic lipids
Time Frame: 6 days
6 days
insulin mediated glucose disposal
Time Frame: 6 days
6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
lipid oxidation
Time Frame: 6 days
6 days
plasma beta-hydroxybutyrate
Time Frame: 6 days
6 days
gene expression in skeletal muscle and adipose tissue
Time Frame: 6 days
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocol 140/04/CE/FBM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Diseases

Clinical Trials on diet intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe