Evidence map›Paper›PMID 29466429›Full record

Trial reportPloS one2018

Population nutrikinetics of green tea extract.

Catharina Scholl, Anna Lepper, Thorsten Lehr, Nina Hanke, Katharina Luise Schneider, Jürgen Brockmöller, Thomas Seufferlein, Julia Carolin Stingl

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

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01360320 (Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
5.0field-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.

NCT01360320 phase2completednot on this map

Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

TypeinterventionalSponsorMartin-Luther-Universität Halle-WittenbergRan2011 to 2019Enrolled1,001ConditionsColorectal Serrated Adenomas, Colorectal Tubular Adenomas, Colorectal Villous Adenomas, Colorectal Tubulovillous AdenomasArmsGreen tea extract of Camellia Sinensis, Green tea extract of Camellia Sinensis followed by placebo
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. Rutin andPharmaceutics · 2024
    Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Therapeutic potential of green tea catechin, (-)-epigallocatechin-3-Phytomedicine plus : international journal of phytotherapy and phytopharmacology · 2023
    Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. 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 4 institutions in 1 country.

Catharina SchollResearch Division, Federal Institute of Drugs and Medical Devices (BfArM), Bonn, Germany.ORCID 0000-0002-1463-5619
Anna LepperInstitute of Pharmacology of Natural Products and Clinical Pharmacology, University of Ulm, Ulm, Germany.
Thorsten LehrClinical Pharmacy, Department of Pharmacy, Saarland University, Saarbrücken, Germany.
Nina HankeClinical Pharmacy, Department of Pharmacy, Saarland University, Saarbrücken, Germany.
Katharina Luise SchneiderResearch Division, Federal Institute of Drugs and Medical Devices (BfArM), Bonn, Germany.
Jürgen BrockmöllerInstitute for Clinical Pharmacology, University Medical Center Göttingen, Georg-August University, Göttingen, Germany.
Thomas SeufferleinDepartment of Internal Medicine I, University of Ulm, Ulm, Germany.
Julia Carolin StinglResearch Division, Federal Institute of Drugs and Medical Devices (BfArM), Bonn, Germany.
Federal Institute for Drugs and Medical Devices · DESaarland University · DEUniversität Ulm · DEUniversitätsmedizin Göttingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Green tea polyphenols may contribute to the prevention of cancer and other diseases. To learn more about the pharmacokinetics and interindividual variation of green tea polyphenols after oral intake in humans we performed a population nutrikinetic study of standardized green tea extract. 84 healthy participants took green tea extract capsules standardized to 150 mg epigallocatechin-gallate (EGCG) twice a day for 5 days. On day 5 catechin plasma concentrations were analyzed using non-compartmental and population pharmacokinetic methods. A strong between-subject variability in catechin pharmacokinetics was found with maximum plasma concentrations varying more than 6-fold. The AUCs of EGCG, EGC and ECG were 877.9 (360.8-1576.5), 35.1 (8.0-87.4), and 183.6 (55.5-364.6) h*μg/L respectively, and the elimination half lives were 2.6 (1.8-3.8), 3.9 (0.9-10.7) and 1.8 (0.8-2.9) h, respectively. Genetic polymorphisms in genes of the drug transporters MRP2 and OATP1B1 could at least partly explain the high variability in pharmacokinetic parameters. The observed variability in catechin plasma levels might contribute to interindividual variation in benefical and adverse effects of green tea polyphenols. Our data could help to gain a better understanding of the causes of variability of green tea effects and to improve the design of studies on the effects of green tea polyphenols in different health conditions.

trial registrationClinicalTrials.gov: NCT01360320.

Indexed as

Pharmacogenomic TestingPlant ExtractsPolymorphism, GeneticPolyphenolsAdultATP-Binding Cassette, Sub-Family C ProteinsCatechinFemaleHumansMaleMultidrug Resistance-Associated Protein 2Organic Anion TransportersTeaABCC2 protein, humanATP-Binding Cassette, Sub-Family C ProteinsCatechinepigallocatechin gallateMultidrug Resistance-Associated Protein 2Organic Anion TransportersPlant ExtractsPolyphenolsSLCO1A2 protein, humanTea

Identifiers

PMID29466429
PMCPMC5821365
OpenAlexW2790644401

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.