NCT00870077

Brief Summary

An increase in dietary protein intake has been shown to blunt the increase in intrahepatic fat induced by high fat feeding in healthy individuals. The purpose of this study is to determine if a protein supplementation decreases intrahepatic fat in obese patients with non-alcoholic fatty liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

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

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 24, 2012

Status Verified

February 1, 2012

Enrollment Period

8 months

First QC Date

March 25, 2009

Last Update Submit

February 23, 2012

Conditions

Non-alcoholic Fatty Liver DiseaseObesity

Keywords

Intrahepatic fatobesitybody fatimpaired glucose tolerance

Outcome Measures

Primary Outcomes (1)

  • intrahepatic fat

    before and after 4 weeks of whey protein supplementation

Secondary Outcomes (2)

  • glucose metabolism

    4-hour oral glucose tolerance test with indirect calorimetry

  • body weight and body fat

    before and after 4 weeks whey protein supplementation

Study Arms (1)

1

EXPERIMENTAL
Dietary Supplement: ProWHEY 94 CFM, SponserR

Interventions

ProWHEY 94 CFM, SponserRDIETARY_SUPPLEMENT

3 times 20g per day

1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI higher than 35 kg/m2
  • age 18-50 years
  • sex male or female
  • ASAT/ALAT \> 1.8

You may not qualify if:

  • treatment with hypolemic or antidiabetic agents
  • blood glucose \> 7 mmol/l
  • alcohol intake \> 20g/day
  • creatinin \> 120 umol/l)
  • contra-indications to Magnetic resonnance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'investigations cliniques "cardiomet"/ CHUV

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

Related Publications (1)

  • Bortolotti M, Maiolo E, Corazza M, Van Dijke E, Schneiter P, Boss A, Carrel G, Giusti V, Le KA, Quo Chong DG, Buehler T, Kreis R, Boesch C, Tappy L. Effects of a whey protein supplementation on intrahepatocellular lipids in obese female patients. Clin Nutr. 2011 Aug;30(4):494-8. doi: 10.1016/j.clnu.2011.01.006. Epub 2011 Feb 1.

    PMID: 21288612DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityGlucose Intolerance

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Luc Tappy, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of physiology

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2009

Study Completion

April 1, 2010

Last Updated

February 24, 2012

Record last verified: 2012-02

Locations

CH(1)