Evidence map›Paper›PMID 31799477›Full record

ArticleContemporary clinical trials communications2020

Intestinal-level anti-inflammatory bioactivities of catechin-rich green tea: Rationale, design, and methods of a double-blind, randomized, placebo-controlled crossover trial in metabolic syndrome and healthy adults.

Joanna K Hodges, Jiangjiang Zhu, Zhongtang Yu, Yael Vodovotz, Guy Brock, Geoffrey Y Sasaki, Priyankar Dey, Richard S Bruno

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03973996 (Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 13% 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.

NCT03973996 nacompletednot on this map

Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome

TypeinterventionalSponsorOhio State UniversityRan2019 to 2021Enrolled46ConditionsDysbiosis, Endotoxemia, Metabolic Syndrome, InflammationArmsGreen Tea Extract, Placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Dietary Inflammatory Index in relation to bone mineral density, osteoporosis risk and fracture risk: a systematic review and meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Pooled it
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Catechins and Proanthocyanidins Involvement in Metabolic Syndrome.International journal of molecular sciences · 2023
    Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Materials today. Bio · 2022
    Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Joanna K HodgesHuman Nutrition Program, The Ohio State University, Columbus, OH, USA.
Jiangjiang ZhuHuman Nutrition Program, The Ohio State University, Columbus, OH, USA.
Zhongtang YuDepartment of Animal Sciences, The Ohio State University, Columbus, OH, USA.
Yael VodovotzDepartment of Food Science and Technology, The Ohio State University, Columbus, OH, USA.
Guy BrockDepartment of Biomedical Informatics, The Ohio State University, Columbus, OH, USA.
Geoffrey Y SasakiHuman Nutrition Program, The Ohio State University, Columbus, OH, USA.
Priyankar DeyHuman Nutrition Program, The Ohio State University, Columbus, OH, USA.
Richard S BrunoHuman Nutrition Program, The Ohio State University, Columbus, OH, USA.
The Ohio State University · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · US

Funding

The OSU Center for Clinical and Translational Science: Advancing Today's Discoveries to Improve HealthUL1TR002733 · NCATS · OHIO STATE UNIVERSITY · PI RINGEL, MATTHEW D · 2018 to 2022
$28.9M
The Ohio State University Center for clinical and Translational ScienceUL1TR001070 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2013 to 2017
$22.6M
NCATS NIH HHS UL1 TR001070NCATS NIH HHS UL1 TR002733
6 · The paper itself

Abstract

Metabolic endotoxemia initiates low-grade chronic inflammation in metabolic syndrome (MetS) and provokes the progression towards more advanced cardiometabolic disorders. Our recent works in obese rodent models demonstrate that catechin-rich green tea extract (GTE) improves gut barrier integrity to alleviate the translocation of gut-derived endotoxin and its consequent pro-inflammatory responses mediated through Toll-like receptor-4/nuclear factor κB (TLR4/NFκB) signaling. The objective of this clinical trial is to establish the efficacy of GTE to alleviate metabolic endotoxemia-associated inflammation in persons with MetS by improving gut barrier function. We plan a double-blind, placebo-controlled cross-over trial in persons with MetS and age- and gender-matched healthy persons (18-65 y; n = 20/group) who will receive a low-energy GTE-rich (1 g/day; 890 mg total catechins) confection snack food while following a low-polyphenol diet for 28 days. Assessments will include measures of circulating endotoxin (primary outcome) and secondary outcomes including biomarkers of endotoxin exposure, region-specific measures of intestinal permeability, gut microbiota composition, diversity, and functions, intestinal and systemic inflammatory responses, and catechins and microbiota-derived catechin metabolites. Study outcomes will provide the first report of the GTE-mediated benefits that alleviate gut barrier dysfunction in relation to endotoxemia-associated inflammation in MetS persons. This is expected to help establish an effective dietary strategy to mitigate the growing burden of MetS that currently affects ~35% of Americans.

Indexed as

BMI, body mass indexCatechinEndotoxemiaGTE, green tea extractGut barrier functionGut dysbiosisGut microbiotaInflammationLBP, LPS binding proteinLPS, lipopolysaccharidesMetabolic syndromeMetS, metabolic syndromeNFκB, nuclear factor κBPCoA, principal coordinates analysisSCFA, short chain fatty acidTeaTLR4, Toll-like receptor-4TNF- α, tumor necrosis factor-α

Identifiers

PMID31799477
PMCPMC6881604
OpenAlexW2991423319

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.