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

University of Lausanne (UNIL)

Status: Completed

Conditions: Metabolic Syndrome X; Liver Diseases

Treatments: Other: diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00523562

protocol 140/04/CE/FBM

Details and patient eligibility

About

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).

Full 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)

Enrollment: 41 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 4 patient groups

normal weight male high fructose diet

Experimental group

Description:

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

Treatment:

Other: diet intervention

offsprings of T2DM high fructose diet

Experimental group

Description:

Effect of diet intervention "high fructose" in healthy non-obese offsprings of patients with type 2 diabetes

Treatment:

Other: diet intervention

normal weight subjects high fat diet

Experimental group

Description:

effects of diet intervention "high fat" in healthy male subjects

Treatment:

Other: diet intervention

Normal weight high fat+protein diet

Experimental group

Description:

effect of diet intervention "high fat + protein" subjects in healthy male subjects

Treatment:

Other: diet intervention