Non-alcoholic Fatty Liver DiseasePROTOBNCT00870077
A Pilot Study on Whey Protein Supplementation in Non Alcoholic Fatty Liver Disease
A study testing ProWHEY 94 CFM, SponserR in people with Non-alcoholic Fatty Liver Disease and Obesity, run by University of Lausanne at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- ProWHEY 94 CFM, SponserR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI higher than 35 kg/m2
- age 18-50 years
- sex male or female
- ASAT/ALAT > 1.8
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre d'investigations cliniques "cardiomet"/ CHUV
Lausanne, Canton of Vaud, CH-1011
About this study
Official title: Effect of a Whey Protein Supplementation on Intrahepatic Lipids in Obese Patients With Non-alcoholic Fatty Liver Disease
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.
Read the detailed description
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
- Non-alcoholic Fatty Liver Disease, Obesity
- Being tested
- ProWHEY 94 CFM, SponserR
- Keywords
- Intrahepatic fat, obesity, body fat, impaired glucose tolerance
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProWHEY 94 CFM, SponserRDietary supplement
3 times 20g per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: ProWHEY 94 CFM, SponserR |
What is being measured
The primary outcome is the main question the study is designed to answer.
intrahepatic fat
Measured: before and after 4 weeks of whey protein supplementation
Secondary outcomes (2)
glucose metabolism
Measured: 4-hour oral glucose tolerance test with indirect calorimetry
body weight and body fat
Measured: before and after 4 weeks whey protein supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc Tappy, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870077
- Sponsor's protocol ID
- Protobese
- Acronym
- PROTOB
- Status last verified
- Feb 2012
- First submitted
- 25 Mar 2009
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21288612
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Whey Protein Supplementation on Intrahepatic Lipids in Obese Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT00870077
- Acronym / sponsor ID
- PROTOB / Protobese
- Conditions
- Non-alcoholic Fatty Liver Disease, Obesity
- Keywords
- Intrahepatic fat, obesity, body fat, impaired glucose tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: ProWHEY 94 CFM, SponserR |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI higher than 35 kg/m2
- age 18-50 years
- sex male or female
- ASAT/ALAT > 1.8
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProWHEY 94 CFM, SponserR3 times 20g per day | Dietary supplement | 1 |
Primary outcome
intrahepatic fat
Time frame: before and after 4 weeks of whey protein supplementation
2 secondary outcomes
glucose metabolism
Time frame: 4-hour oral glucose tolerance test with indirect calorimetry
body weight and body fat
Time frame: before and after 4 weeks whey protein supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
- Derived from this study: PubMed 21288612Bortolotti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Tappy, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProWHEY 94 CFM, SponserR in people with Non-alcoholic Fatty Liver Disease and Obesity, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intrahepatic fat (time frame: before and after 4 weeks of whey protein supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012.