Functional Roll for Non-alcoholic Fatty Liver Disease

Summary

Background: Low physical activity and poor eating habits (incl. high fat and carbohydrates but low fiber intake) are the main reason of obesity epidemic in western societies. The most common clinical complication of this condition is non-alcoholic fatty liver disease (NAFLD), that can lead to liver cirrhosis and its complications. Recent studies show that gut dysbiosis may play a crucial role in the pathogenesis of NAFLD. On the other hand plant fiber shows beneficial properties in remodeling of the gut microbiome. Aim: The project aims to create low-calorie bars / snacks with an increased fiber content (12 g/bar), replacing the second breakfast and/or afternoon tea. The main scientific aim is to examine the influence of the extra supply of fiber on i. gut microbiota composition and metabolism and ii. liver function in patients with NAFLD. Methods: Randomized placebo-controlled double blind study. A group of patients diagnosed with NAFLD, divided into 2 groups: study (12% fiber bar) and placebo (maltodextrin bar). Two study phases: preliminary study (5 weeks, 20 patients) and main study (24 weeks, 120 patients). Both clinical and laboratory (stool and serum) aspects will be analyzed, incl. anthropometric measurements, nutrition tests (food frequency questionnaire), health-related quality of life, liver ultrasound and elastography, serum and stool biochemistry and microbiome analysis.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

DIETARY_SUPPLEMENT

plant fiber

The patients with NAFLD (study and control group) will receive low-processed rolls with an 12 g plant fiber content twice daily, which would be a convenient for easy replenishment of the amount of vegetable fiber (act as prebiotic) in the diet. The intervention will be preceded by a 21 day wash-out period during which subjects will be asked to avoid foods containing large amount of fiber.

DIETARY_SUPPLEMENT

maltodextrin bar

The patients with NAFLD (placebo group) will receive maltodextrin bars twice daily, which would be a convenient and easy-to-eat snack replacing the second breakfast and afternoon tea. The bars must be eaten with 180 ml of water or unsweetened liquid. The intervention will be preceded by a 21 day wash-out period during which subjects will be asked to avoid foods containing large amount of fiber.

Sponsors & Collaborators

• Humboldt-Universität zu Berlin

  collaborator OTHER

• Pomeranian Medical University Szczecin

  lead OTHER

Principal Investigators

• Ewa Stachowska, Professor · Department of Biochemistry and Human Nutrition

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2019-09-01

Completion

2019-11-01

Countries

• Poland

Study Locations