Protein-rich Diet and NAFLD in Bariatric Surgery

Protein-rich Diet and Non-Alcoholic Fatty Liver Disease in Bariatric Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02400099

Enrollment

Registered

2015-03-26

Start date

2015-06-30

Completion date

Unknown

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease, Obesity

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.

Interventions

DIETARY_SUPPLEMENTHigh-protein low calorie diet

DIETARY_SUPPLEMENTControl low calorie diet

OTHERAnthropometrical measurements

OTHERBody composition

OTHER8-h metabolic profile

OTHERLiver biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Liver fat content assessment	1 year

Secondary

Measure	Time frame
Insulin sensitivity assessment	1 year
fat free mass assessment	1 year

Countries

Italy

Contacts

Primary ContactGeltrude Mingrone, Professor

gmingrone@rm.unicatt.it0630154395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026