NCT00558740

Brief Summary

Individuals submitted to a high-fat or a high-fructose/sucrose diet develop, over a 6 day-period, several features of the metabolic syndrome, including increased plasma triglycerides, increased intrahepatic lipids, and decreased hepatic insulin sensitivity. It has been recently observed that the increase in intrahepatic lipids observed after a high fat diet is largely prevented when protein intake is concomitantly increased. This suggests that dietary protein protects the liver against some of the deleterious effects of a high fat diet. Mechanisms underlying this effect of protein may include an increased hepatic fat oxidation. The aims of this study are:

  1. 1.to evaluate the effects of dietary protein on several major pathways involved in hepatic lipid metabolism ( ketogenesis, lipid oxidation, de novo lipogenesis, VLDL-triglyceride secretion
  2. 2.to determine whether the decrease in intra-hepatic lipids observed when dietary protein intake is increased are to be attributed to acute or long-term effects of proteins

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 10, 2012

Status Verified

November 1, 2009

Enrollment Period

3 months

First QC Date

November 14, 2007

Last Update Submit

February 9, 2012

Conditions

Keywords

Dietary proteinFructoseVLDL-triglyceridesHepatic de novo lipogenesisLipid oxidation

Outcome Measures

Primary Outcomes (1)

  • Whole body lipid oxidation Medium chain triglyceride oxidation Long chain triglyceride oxidation VLDL-triglyceride kinetics Hepatic de novo lipogenesis whole body glucose and glycerol turnover

    acute effects of dietary proteins and after 4 days on a high protein day

Secondary Outcomes (1)

  • Energy expenditure Glucagon/insulin ratio Plasma growth hormone concentrations gene expression in subcutaneous adipose tissue Plasma ketone bodies concentrations

    acute effects of dietary proteins and after 4 days on a high protein day

Study Arms (1)

healthy volunteers

Other: high protein intake

Interventions

acute high protein intake chronic (6-day) high protein intake acute+chronic high protein intake control

healthy volunteers

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • age 18-30
  • sex male
  • BMI 19-25 kg/m2
  • sedentary
  • good physical health

You may not qualify if:

  • family history of diabetes
  • use of drugs or illicit substances
  • consumption of alcohol \>50 g/week
  • vegetarians
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • l Tappy, MD

    University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 15, 2007

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 10, 2012

Record last verified: 2009-11

Locations