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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-01-31

Brief Summary

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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).

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Detailed Description

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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)

Conditions

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Metabolic Syndrome X Liver Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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normal weight male high fructose diet

Effects of diet intervention " high fructose" in normal weight subjects

Group Type EXPERIMENTAL