A Pilot Study on Whey Protein Supplementation in Non Alcoholic Fatty Liver Disease

NCT ID: NCT00870077

Last Updated: 2012-02-24

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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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12 obese patients will be be treated with a dietary whey protein supplementation over 4 weeks. Their intrahepatic fat content, glucose tolerance, and body weight will be evaluated before and after 4 weeks of supplementation.

Conditions

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Non-alcoholic Fatty Liver Disease Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ProWHEY 94 CFM, SponserR

Intervention Type DIETARY_SUPPLEMENT

3 times 20g per day

Interventions

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ProWHEY 94 CFM, SponserR

3 times 20g per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne

OTHER

Sponsor Role lead

Responsible Party

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Luc Tappy, MD

professor of physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luc Tappy, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

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Centre d'investigations cliniques "cardiomet"/ CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 21288612 (View on PubMed)

Other Identifiers

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Protobese

Identifier Type: -

Identifier Source: org_study_id

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