Evidence map›Paper›PMID 26635079›Full record

Trial reportBMC gastroenterology2015

Gut microbiota manipulation with prebiotics in patients with non-alcoholic fatty liver disease: a randomized controlled trial protocol.

Jennifer E Lambert, Jill A Parnell, Bertus Eksteen, Maitreyi Raman, Marc R Bomhof, Kevin P Rioux, Karen L Madsen, Raylene A Reimer

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02568605 (Prebiotic Fibre Supplementation and Gut Microbiota in Non-alcoholic Fatty Liver Disease), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02568605 nacompletednot on this map

Prebiotic Fibre Supplementation and Gut Microbiota in Non-alcoholic Fatty Liver Disease

TypeinterventionalSponsorUniversity of CalgaryRan2015 to 2022Enrolled45ConditionsNon-alcoholic Fatty Liver DiseaseArmsPrebiotic fibre, Placebo, Weight Loss
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

  1. Pooled it
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  4. Review
  5. Article
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  15. Diet-Regulating Microbiota and Host Immune System in Liver Disease.International journal of molecular sciences · 2021
    Review
  16. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Jennifer E LambertFaculty of Kinesiology, University of Calgary, 2500 University Dr. NW, Calgary, AB, T2N 1N4, Canada. jlambert@ucalgary.ca.
Jill A ParnellHealth and Physical Education, Mount Royal University, 4825 Mount Royal Gate SW, Calgary, AB, T3E 6K6, Canada. jparnell@mtroyal.ca.
Bertus EksteenSnyder Institute for Chronic Diseases, Health Research and Innovation Center, University of Calgary, 3280 Hospital Drive NW, Calgary, AB, T2N 4N1, Canada. b.eksteen@ucalgary.ca.
Maitreyi RamanDivision of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, AB, T2N 4N1, Canada. mkothand@ucalgary.ca.
Marc R BomhofFaculty of Kinesiology, University of Calgary, 2500 University Dr. NW, Calgary, AB, T2N 1N4, Canada. mrbomhof@ucalgary.ca.
Kevin P RiouxDivision of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, AB, T2N 4N1, Canada. kprioux@ucalgary.ca.
Karen L MadsenDivision of Gastroenterology, Centre of Excellence for Gastrointestinal Inflammation and Immunity Research, 7-142 Katz Group-Rexall Centre, University of Alberta, Edmonton, AB, T6G 2C2, Canada. karen.madsen@ualberta.ca.
Raylene A ReimerFaculty of Kinesiology, University of Calgary, 2500 University Dr. NW, Calgary, AB, T2N 1N4, Canada. reimer@ucalgary.ca.
University of Calgary · CAMount Royal University · CAUniversity of Alberta · CA

Funding

Canadian Institutes of Health Research MOP-136889
6 · The paper itself

Abstract

backgroundEvidence for the role of the gut microbiome in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is emerging. Strategies to manipulate the gut microbiota towards a healthier community structure are actively being investigated. Based on their ability to favorably modulate the gut microbiota, prebiotics may provide an inexpensive yet effective dietary treatment for NAFLD. Additionally, prebiotics have established benefits for glucose control and potentially weight control, both advantageous in managing fatty liver disease. Our objective is to evaluate the effects of prebiotic supplementation, adjunct to those achieved with diet-induced weight loss, on heptic injury and liver fat, the gut microbiota, inflammation, glucose tolerance, and satiety in patients with NAFLD. METHODS/

designIn a double blind, placebo controlled, parallel group study, adults (BMI ≥25) with confirmed NAFLD will be randomized to either a 16 g/d prebiotic supplemented group or isocaloric placebo group for 24 weeks (n = 30/group). All participants will receive individualized dietary counseling sessions with a registered dietitian to achieve 10 % weight loss. Primary outcome measures include change in hepatic injury (fibrosis and inflammation) and liver fat. Secondary outcomes include change in body composition, appetite and dietary adherence, glycemic and insulinemic responses and inflammatory cytokines. Mechanisms related to prebiotic-induced changes in gut microbiota (shot-gun sequencing) and their metabolic by-products (volatile organic compounds) and de novo lipogenesis (using deuterium incorporation) will also be investigated. DISCUSSION: There are currently no medications or surgical procedures approved for the treatment of NAFLD and weight loss via lifestyle modification remains the cornerstone of current care recommendations. Given that prebiotics target multiple metabolic impairments associated with NAFLD, investigating their ability to modulate the gut microbiota and hepatic health in patients with NAFLD is warranted.

trial registrationClinicalTrials.gov (NCT02568605) Registered 30 September 2015.

Indexed as

Gastrointestinal MicrobiomeAdolescentAdultAgedBody Mass IndexClinical ProtocolsDietary SupplementsDouble-Blind MethodFemaleHumansLipogenesisLiverLiver CirrhosisMaleMiddle AgedNon-alcoholic Fatty Liver DiseasePrebiotics

Identifiers

PMID26635079
PMCPMC4669628
OpenAlexW2201555220

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.