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Non-Alcoholic Fatty Liver DiseaseNAFLDrollNCT04520724

Functional Roll for Non-alcoholic Fatty Liver Disease

A study testing plant fiber and maltodextrin bar in people with Non-Alcoholic Fatty Liver Disease, run by Pomeranian Medical University Szczecin at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Alcoholic Fatty Liver Disease
What is being tested?
plant fiber and maltodextrin bar
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 sitePoland
Study dates
1 Nov 2018to 1 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NAFLD diagnosis based on non-invasive assessment

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Pomeranian Medical University

    Szczecin, West Pomeranian Voivodeship, 70-393

Other trials in Poland

About this study

Official title: The Production of a Functional Roll Supporting the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD)

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.

Read the detailed description

Background: High percentage of the Polish suffer from overweight and obesity. According to previous report prepared for the government, the percentage of overweight and obese people in Poland was 36.6% and 16.7% respectively, which constitutes 53.3% of the adult population in Poland. This state that body mass of a statistical -adult inhabitant of Poland is over the average one, calculated for 28 countries of the European Union. It was assumed that 25% of individuals aged ≥15 years in 2015 experienced NAFLD in France, Germany, Spain and the UK.

Obesity results from unhealthy lifestyle - too high calorie intake, too little physical activity and low fiber content in the diet. The most common clinical complication of overweight and obesity is non-alcoholic fatty liver disease (NAFLD). In the United States, 20-30% of adults suffer from NAFLD, while in the European adult population the percentage varies 14-21%. In addition, 30-50% of diabetics and 93% of people with hyperlipidemia suffer from NAFLD. The incidence of NAFLD increases with age (the disease is diagnosed between 40-65 years of age predominantly), and is sex-dependent - males suffer from this disease most often compared to women. NAFLD incidence within obese patients (BMI≥30) was found to be equal to 78%. The NAFLD risk factors include: obesity, environmental factors (low physical activity, fructose in the diet) changes in the intestinal microbiome (induced by eg. too low fiber supply) epigenetic factors, insulin resistance and genetic factors So far, there is no effective drug that can be effective in NAFLD therapy. Current treatments include changes in eating habits (proper composition of meals) leading to weight loss and thus remodeling the gut microbiome, as well as adequate physical activity. One of ingredients with beneficial effects for liver structure and function (liver cells - hepatocytes) is fiber. Plant fiber is a key component of the diet, preferably regulating metabolic processes and maintaining a healthy body. This is because the plant fiber acts as a nutrient for the intestinal flora (microbiota) and it "travels" through the intestine, ensuring its good peristalsis and proper stool formation. Undigested plant fiber including xylan polysaccharides, pectin, arabinose-containing carbohydrates as vegetable pectins, cellulose, hemicellulose, resistant starch reach unchanged into the colon, where they are metabolized by intestinal microorganisms. The fiber serves as substrate for the synthesis of short-chain fatty acids (SCFAs): propionate, acetate and butyrate. Especially the latter one - butyric acid (butyrate) is considered as a potential therapeutic agent in NAFLD. Butyrate can be treated exceptionally because of its high biological activity, which includes modulations of epigenetic functions (butyrate is a histone deacetylase (HDAC) inhibitor), energy functions (70% ATP synthesis takes place in colonocytes) and functions as a G protein-coupled receptor activator (GPCR). Consequently, the content of prebiotic vegetable fiber in the diet controls the productions of butyrate. It was shown that already after 24 hours since higher fiber supply (> 30g per day), the diversity of the microbiota was higher and the SCFAs synthesis increased. Meanwhile, the amount of fiber consumed in industrialized countries is very low. It was estimated that adults in the US provide an average of 12-18 grams of dietary fiber per day. In Europe the fiber intake varies between 16-29 g/day. At the same time in African communities (Burkina Faso, Tanzania) dietary fiber intake is high providing balance within microbial milieu within the gut, thus greater SCFA synthesis and lower titre of inflammatory factors. In comparison, in Poland the average consumption of fiber in adults is 19 - 34 g / day for men and 19 - 20 g / day for women. On the other hand most of the Nutritional Societies in the world recommend fiber intake not less than 25 g / day for women and 38 g / day for men.

As a result of inappropriate diet incl. low fiber intake obese patients show disturbances in the microbiota composition and metabolism, what results in dysfunction of intestinal barrier and increases the influx of proinflammatory substances to the liver. In this way gut dysbiosis may trigger and aggravate the liver injury in NAFLD.

Aims: The project aims to create low-calorie bars / snacks with an increased fiber content (12 g / bar), which would be a convenient and easy-to-eat snack replacing the second breakfast and/or afternoon tea. The main scientific aim is to examine whether a simple correction of the diet consisting of the extra supply of fiber in NAFLD patients will improve the microbiome composition and metabolism (inc. fermentation and production of SCFA), will support the intestinal barrier and eventually improve liver function.

Being tested
plant fiber, maltodextrin bar
Keywords
gut microbiome, plant fiber, Non-Alcoholic Fatty Liver Disease
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • plant fiberDietary supplement

    Also called high fiber rolls

    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.

  • maltodextrin barDietary 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.

Study groups in NCT04520724
Study groupRoleWhat they receive
Study groupExperimental30 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.
Receives: Dietary Supplement: plant fiber
Placebo groupPlacebo comparator30 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.
Receives: Dietary Supplement: maltodextrin bar

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 weeks

Secondary outcomes (4)
  1. Gut microbiome

    Changes in gut microbiota composition and metabolism (16 SrRNA bacterial genomic, bacterial metabolites) at enrollment and at the end-point ( The gut microbiota will be asses in Operational taxonomic units (OTUs). Microbiota richness and eveness will be asses in Shannon index, Chao and Simpson index.

    Measured: 24 weeks

  2. Gut barriere permeability

    Changes in gut barriere parameters permeability (SCFA, zonulin) at enrollment and at the end-point . ( gut barriere permeability will be asses in (µmol/g SCFA), and in mg/ml zonulin in stool.

    Measured: 24 weeks

  3. Serum biochemistry

    Lipid, glucose and liver biochemistry at enrollment and at the end-point (enzymes acitivity will be asses in U/l; lipids (cholesterol, LDL ch, HDL ch TG in mg/l, glucose in mg/dl). Enzymes (ALaT, ASpAT) in U/l.

    Measured: 24 weeks

  4. Anthropometric

    Changes in anthropometric (BIA, TANITA) and indirect calorimetry at enrollment and at the end-point (weight and height will be combined to report BMI in kg/m2, fatty tissue in percent).

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start1 Nov 2018
  3. Primary completion1 Sep 2019
  4. Study completion1 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04520724
Sponsor's protocol ID
WNoZ 330/04/S/17
Acronym
NAFLDroll
Status last verified
Aug 2020
First submitted
31 Jul 2018
Last updated
20 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28630692
  • 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.

    PubMed 29085205

Questions about this trial

What is this clinical trial studying?

A study testing plant fiber and maltodextrin bar in people with Non-Alcoholic Fatty Liver Disease, run by Pomeranian Medical University Szczecin at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NAFLD severity assessment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04520724, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.

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