Functional Roll for Non-alcoholic Fatty Liver Disease

NCT04520724 | Completed

• 1 other identifier: WNoZ 330/04/S/17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gut microbiome; plant fiber; Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• NAFLD severity assessment

  Serum non-invasive NAFLD severity parameters, liver ultrasonography and elastography at enrollment and at the end-point (NAFLD. Fibrosis (scarring) and steatosis will be asses FibroScan as (FibroScan steatosis result -CAP) in decibels per meter (dB/m). Elastography (TE Transient elastography) will be asses in kPa.

  24 weeks

Secondary Outcomes (4)

• Gut microbiome

  24 weeks

• Gut barriere permeability

  24 weeks

• Serum biochemistry

  24 weeks

• Anthropometric

  24 weeks

Study Arms (2)

Study group

EXPERIMENTAL

30 patients with NAFLD which consumes rolls with a higher fiber content twice daily (ca. 300 kcal; no less than 12 g of fiber) for 8 weeks.30 patients with NAFLD which consumes rolls with a higher fiber content twice daily (12 g of fiber/per roll) for 8 weeks. Rolls should be eaten for 1st and 2nd breakfast. Before starting the study, patients will receive nutritional guidelines how compose a meal that the caloric content does not exceed 400 kcal per breakfast. At the beginning patients will be trained by licensed dietitians on the principles of diet in NAFLD. During 8 weeks of intervention, patients will have telephone access to consultations with a dietitian.

Dietary Supplement: plant fiber

Placebo group

PLACEBO COMPARATOR

30 patients with NAFLD which consumes rolls with a lower fiber content twice daily (ca. 300 kcal; no less than 6 g of fiber) for 8 weeks.30 patients with NAFLD which consumes rolls with a lower fiber content twice daily (6 g of fiber/per roll) for 8 weeks. Rolls should be eaten for 1st and 2nd breakfast. Before starting the study, patients will receive nutritional guidelines how compose a meal that the caloric content does not exceed 400 kcal per breakfast. At the beginning patients will be trained by licensed dietitians on the principles of diet in NAFLD. During 8 weeks of intervention, patients will have telephone access to consultations with a dietitian.

Dietary Supplement: maltodextrin bar

Interventions

plant fiber DIETARY_SUPPLEMENT

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.

Also known as: high fiber rolls

Study group

maltodextrin bar DIETARY_SUPPLEMENT

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NAFLD diagnosis based on non-invasive assessment

You may not qualify if:

• other liver disease: ALD, viral hepatitis, AIH, cholestatic liver disease, Wilson's disease, hemochromatosis, hepatobiliary cancer (HCC, CCA), incl. liver cirrhosis of any aetiology
• alcohol consumption \> 21 standard drinks per week in men or \>14 standard drinks per week in women over at least a two-year period,
• diabetes
• pregnancy
• celiac disease
• inflammation bowel disease
• starvation, parenteral nutrition
• drugs: metformin and other antidiabetics, statins, amiodarone, methotrexate, tamoxifen, glucocorticoids, valproate, anti-retroviral agents for HIV

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead
• Humboldt-Universität zu Berlin: collaborator

Study Sites (1)

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 70-393, Poland

Location

Related Publications (2)

• Peters HPF, Schrauwen P, Verhoef P, Byrne CD, Mela DJ, Pfeiffer AFH, Riserus U, Rosendaal FR, Schrauwen-Hinderling V. Liver fat: a relevant target for dietary intervention? Summary of a Unilever workshop. J Nutr Sci. 2017 May 8;6:e15. doi: 10.1017/jns.2017.13. eCollection 2017.

  PMID: 28630692 BACKGROUND

• Singh S, Osna NA, Kharbanda KK. Treatment options for alcoholic and non-alcoholic fatty liver disease: A review. World J Gastroenterol. 2017 Sep 28;23(36):6549-6570. doi: 10.3748/wjg.v23.i36.6549.

  PMID: 29085205 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ewa Stachowska, Professor

  Department of Biochemistry and Human Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 20, 2020
• Study Start: November 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)