NCT02400099

Brief Summary

Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 23, 2015

Last Update Submit

March 23, 2015

Conditions

ObesityNon-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Liver fat content assessment

    1 year

Secondary Outcomes (2)

  • Insulin sensitivity assessment

    1 year

  • fat free mass assessment

    1 year

Study Arms (2)

High-protein low calorie diet (HPLC)

ACTIVE COMPARATOR

900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)

Dietary Supplement: High-protein low calorie dietOther: Anthropometrical measurementsOther: Body compositionOther: 8-h metabolic profileOther: Liver biopsy

Control low calorie diet (CLC)

PLACEBO COMPARATOR

900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)

Dietary Supplement: Control low calorie dietOther: Anthropometrical measurementsOther: Body compositionOther: 8-h metabolic profileOther: Liver biopsy

Interventions

High-protein low calorie dietDIETARY_SUPPLEMENT
High-protein low calorie diet (HPLC)
Control low calorie dietDIETARY_SUPPLEMENT
Control low calorie diet (CLC)
Anthropometrical measurementsOTHER
Control low calorie diet (CLC)High-protein low calorie diet (HPLC)
Body compositionOTHER
Control low calorie diet (CLC)High-protein low calorie diet (HPLC)
8-h metabolic profileOTHER
Control low calorie diet (CLC)High-protein low calorie diet (HPLC)
Liver biopsyOTHER
Control low calorie diet (CLC)High-protein low calorie diet (HPLC)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Morbidly obese subjects with a BMI \>40 kg/m2 who are eligible for bariatric surgery and have accepted to undergo RYGB
  • Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
  • Stable medication
  • Provision of informed consent

You may not qualify if:

  • Patients not eligible for laparoscopic RYGB
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University School of Medicine

Rome, 00168, Italy

Location

MeSH Terms

Conditions

ObesityNon-alcoholic Fatty Liver Disease

Interventions

Body CompositionMetabolome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biochemical PhenomenaChemical PhenomenaMetabolismBody ConstitutionPhysiological Phenomena

Central Study Contacts

Geltrude Mingrone, Professor

CONTACT

0630154395gmingrone@rm.unicatt.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

IT(1)