Evidence map›Paper›PMID 31171016›Full record

ArticleTrials2019

Pomegranate juice to reduce fecal calprotectin levels in inflammatory bowel disease patients with a high risk of clinical relapse: Study protocol for a randomized controlled trial.

Eleonora Scaioli, Andrea Belluzzi, Luigi Ricciardiello, Daniele Del Rio, Enrica Rotondo, Pedro Mena, Eleonora Derlindati, Francesca Danesi

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03000101 (New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.3field-weighted citation impact, top 22% 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.

NCT03000101 nacompletednot on this map

New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)

TypeinterventionalSponsorIRCCS Azienda Ospedaliero-Universitaria di BolognaRan2017 to 2023Enrolled18ConditionsCrohn's Disease, Ulcerative ColitisArms100% pomegranate juice, placebo beverage
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Update on the Potential ofAdvances in pharmacological and pharmaceutical sciences · 2024
    Review
  5. Pomegranate (International journal of molecular sciences · 2023
    Review
  6. Review
  7. Article
  8. Therapeutic Effects ofJournal of nutrition and metabolism · 2021
    Review
  9. Article
  10. A New Extract from Pomegranate (Molecules (Basel, Switzerland) · 2020
    Article
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.

Eleonora ScaioliGastroenterological Unit, Department of Medical and Surgical Sciences, University of Bologna, Via Massarenti 9, 40138, Bologna, Italy.
Andrea BelluzziGastroenterological Unit, St. Orsola-Malpighi Hospital, Via Massarenti 9, 40138, Bologna, Italy.
Luigi RicciardielloGastroenterological Unit, Department of Medical and Surgical Sciences, University of Bologna, Via Massarenti 9, 40138, Bologna, Italy.
Daniele Del RioDepartment of Veterinary Science, University of Parma, Strada del Taglio, 10, 43126, Parma, Italy.
Enrica RotondoHuman Nutrition Unit, Department of Agricultural and Food Sciences, Campus of Food Science, University of Bologna, Piazza Goidanich, 60, 47521, Cesena, FC, Italy.
Pedro MenaHuman Nutrition Unit, Department of Food and Drug, University of Parma, Medical School, Building C, Via Volturno 39, 43125, Parma, Italy.
Eleonora DerlindatiHuman Nutrition Unit, Department of Agricultural and Food Sciences, Campus of Food Science, University of Bologna, Piazza Goidanich, 60, 47521, Cesena, FC, Italy.
Francesca DanesiHuman Nutrition Unit, Department of Agricultural and Food Sciences, Campus of Food Science, University of Bologna, Piazza Goidanich, 60, 47521, Cesena, FC, Italy. francesca.danesi@unibo.it.ORCID http://orcid.org/0000-0002-4134-0066
University of Bologna · ITUniversity of Parma · ITIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · IT

Funding

Ministero dell'Istruzione, dell'Università e della Ricerca RBSI14LHMB
6 · The paper itself

Abstract

backgroundInflammatory bowel disease (IBD) is a chronic condition characterized by recurrent episodes of intestinal inflammation and is thought to be related to an autoimmune reaction to genetic and environmental factors. Although evidence indicates that a polyphenolic-rich diet plays an important role in modulating aspects of chronic inflammation, few studies have focused on the effect of ellagitannin (ET)-rich food consumption on long-term remission maintenance in IBD patients with a high risk of clinical relapse. Therefore, we hypothesize that supplementation with a pomegranate juice, a naturally rich source of ETs, could significantly modulate the markers of mucosal and systemic inflammation relative to a control group receiving a placebo. METHODS/

designThis double-blind, randomized controlled trial includes patients with IBD involving the colorectum who have been in stable therapy for at least the three previous months and have a high risk of clinical relapse. Participants are randomly allocated to one of two groups: active supplementation (125 mL of cv. Wonderful pomegranate juice) or placebo (125 mL) taken twice daily for 12 weeks. The primary outcome is changes in the fecal neutrophil-derived protein calprotectin, a surrogate marker of mucosal improvement, between the two groups from baseline to 12 weeks later. The secondary outcomes include transcriptomic changes in peripheral blood mononuclear cells and intestinal biopsies and changes in circulating inflammatory markers and trimethylamine-N-oxide levels. Pomegranate ET-derived metabolites are identified and quantified in plasma and urine samples. DISCUSSION: The results will provide information on the possible reduction of fecal calprotectin levels following the consumption of pomegranate juice. The findings will also show the in vivo metabolism of pomegranate ETs. Finally, the effect of 12-week pomegranate juice consumption on local and systemic inflammatory markers will be elucidated, which will likely provide additional insights into the maintenance of remission in IBD patients.

trial registrationClinicalTrials.gov, NCT03000101 . Registered on 21 December 2016.

Indexed as

Fruit and Vegetable JuicesPomegranateAdolescentAdultAgedAged, 80 and overAnti-Inflammatory AgentsBiomarkersDouble-Blind MethodDown-RegulationFecesFemaleHumansHydrolyzable TanninsInflammation MediatorsInflammatory Bowel DiseasesAnti-Inflammatory AgentsBiomarkersHydrolyzable TanninsInflammation MediatorsLeukocyte L1 Antigen ComplexCrohn’s diseaseEllagitanninsFecal calprotectinIBDInflammationInflammatory bowel diseasePomegranate juicePunica granatum L.Ulcerative colitis

Identifiers

PMID31171016
PMCPMC6554985
OpenAlexW2948210926

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.