Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High-protein low calorie diet (HPLC)
900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)
High-protein low calorie diet
Anthropometrical measurements
Body composition
8-h metabolic profile
Liver biopsy
Control low calorie diet (CLC)
900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)
Control low calorie diet
Anthropometrical measurements
Body composition
8-h metabolic profile
Liver biopsy
Interventions
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High-protein low calorie diet
Control low calorie diet
Anthropometrical measurements
Body composition
8-h metabolic profile
Liver biopsy
Eligibility Criteria
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Inclusion Criteria
* Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
* Stable medication
* Provision of informed consent
Exclusion Criteria
* Incapacity to give a valid informed consent or unwilling to give the consent
* Pregnancy or lactating
* Type 2-diabetes mellitus
* Significant illness within the two weeks preceding surgery, as judged by the physician.
* Obvious infection (bacteria, virus etc)
* Major cardiovascular disease
* Major gastrointestinal, respiratory, or any hormonal disorders
* History of drug addiction and/or alcohol use
* Suspected or confirmed poor compliance
* Alcohol consumption of \> 20 g per day in the case of women and \> 30 g per day in the case of men for at least 3 consecutive months during the previous 5 years
* Presence of hepatitis C or frank cirrhosis.
20 Years
60 Years
ALL
No
Sponsors
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Federico II University
OTHER
Catholic University of the Sacred Heart
OTHER
Responsible Party
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Geltrude Mingrone
Associate Professor
Locations
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Catholic University School of Medicine
Rome, , Italy
Countries
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Central Contacts
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Other Identifiers
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UCSC-2015
Identifier Type: -
Identifier Source: org_study_id
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