Protein-rich Diet and NAFLD in Bariatric Surgery

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Obesity; Non-alcoholic Fatty Liver Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02400099

UCSC-2015

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

High-protein low calorie diet (HPLC)

Active Comparator group

Description:

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

Treatment:

Other: Liver biopsy

Dietary Supplement: High-protein low calorie diet

Other: 8-h metabolic profile

Other: Body composition

Other: Anthropometrical measurements

Control low calorie diet (CLC)

Placebo Comparator group

Description:

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

Treatment:

Other: Liver biopsy

Other: 8-h metabolic profile

Dietary Supplement: Control low calorie diet

Other: Body composition

Other: Anthropometrical measurements