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Status unknownNCT02400099Updated Mar 26, 2015

Protein-rich Diet and NAFLD in Bariatric Surgery

An interventional study of High-protein low calorie diet and Control low calorie diet in Obesity and Non-alcoholic Fatty Liver Disease, sponsored by Catholic University of the Sacred Heart. Status unknown at 1 site in Italy. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-03-26.

Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Non-alcoholic Fatty Liver Disease
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    High-protein low calorie diet (HPLC)

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

    Dietary Supplement: High-protein low calorie diet · Other: Anthropometrical measurements · Other: Body composition · Other: 8-h metabolic profile · Other: Liver biopsy

  • Placebo comparator
    Control low calorie diet (CLC)

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

    Dietary Supplement: Control low calorie diet · Other: Anthropometrical measurements · Other: Body composition · Other: 8-h metabolic profile · Other: Liver biopsy

Interventions

  • Dietary supplementHigh-protein low calorie diet
  • Dietary supplementControl low calorie diet
  • OtherAnthropometrical measurements
  • OtherBody composition
  • Other8-h metabolic profile
  • OtherLiver biopsy
06

What researchers measure

Primary outcomes

  1. Liver fat content assessment

    Time frame: 1 year

Secondary outcomes

  1. Insulin sensitivity assessment

    Time frame: 1 year

  2. fat free mass assessment

    Time frame: 1 year

07

Study locations

1 site
  • Catholic University School of Medicine
    Rome, 00168, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02400099
Lead sponsor
Catholic University of the Sacred Heart
Collaborators
Federico II University
Responsible party
Geltrude Mingrone (Associate Professor, Catholic University of the Sacred Heart) — Principal investigator
First posted
Mar 26, 2015
Start date
Jun 2015
Primary completion
Jun 2016 (estimated)
Last update
Mar 26, 2015

Study contacts

Geltrude Mingrone, Professor
Contact
gmingrone@rm.unicatt.it
0630154395 ext. 0039
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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