Evidence map›Paper›PMID 26051348›Full record

Trial reportFood and chemical toxicology : an international journal published for the British Industrial Biological Research Association2015

The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial.

Allison M Dostal, Hamed Samavat, Sarah Bedell, Carolyn Torkelson, Renwei Wang, Karen Swenson, Chap Le, Anna H Wu, Giske Ursin, Jian-Min Yuan and 1 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05195918 (Dose Ranging Study of Oral Epigallocatechin-3-gallate), which is not on this map. Cited by 46 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 2 pooled it
5.1field-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.

NCT05195918 phase1completednot on this mapstarted 2023, after this paper: background citation

Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug Effect

TypeinterventionalSponsorHal ChapmanRan2023 to 2026Enrolled50ConditionsIdiopathic Pulmonary FibrosisArmsEGCG 300 mg + Nintedanib, EGCG 300 mg + Pirfenidone, Placebo 2 capsules + Nintedanib or Pirfenidone, EGCG 600 mg + Nintedanib, EGCG 600 mg + Pirfenidone
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 2 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
  2. Green tea (Camellia sinensis) for the prevention of cancer.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. 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

11 authors at 6 institutions in 2 countries.

Allison M DostalDepartment of Food Science and Nutrition, University of Minnesota, 1334 Eckles Ave., St. Paul, MN 55108, USA. Electronic address: dost0022@umn.edu.
Hamed SamavatDepartment of Food Science and Nutrition, University of Minnesota, 1334 Eckles Ave., St. Paul, MN 55108, USA. Electronic address: samav005@umn.edu.
Sarah BedellDepartment of Food Science and Nutrition, University of Minnesota, 1334 Eckles Ave., St. Paul, MN 55108, USA. Electronic address: sbedell@umn.edu.
Carolyn TorkelsonDepartment of Family Medicine, University of Minnesota Medical Center, 420 Delaware St. SE, Minneapolis, MN 55455, USA. Electronic address: tork0004@umn.edu.
Renwei WangUniversity of Pittsburgh Cancer Institute, Division of Cancer Control and Population Sciences, University of Pittsburgh Graduate School of Public Health, Department of Epidemiology, 5150 Centre Ave., Pittsburgh, PA 15232, USA. Electronic address: wangr2@upmc.edu.
Karen SwensonVirginia Piper Cancer Institute, Allina Health System, 800 East 28th St., Suite 602, Minneapolis, MN 55407, USA. Electronic address: karen.swenson2@allina.com.
Chap LeBiostatistics and Informatics Core, Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA. Electronic address: chap@umn.edu.
Anna H WuDepartment of Preventive Medicine, University of Southern California Keck School of Medicine, 1975 Zonal Ave., Los Angeles, CA 90033, USA. Electronic address: anna.wu@med.usc.edu.
Giske UrsinDepartment of Preventive Medicine, University of Southern California Keck School of Medicine, 1975 Zonal Ave., Los Angeles, CA 90033, USA; Cancer Registry of Norway, Oslo, Norway; Department of Nutrition, University of Oslo, Oslo, Norway. Electronic address: Giske.Ursin@kreftregisteret.no.
Jian-Min YuanUniversity of Pittsburgh Cancer Institute, Division of Cancer Control and Population Sciences, University of Pittsburgh Graduate School of Public Health, Department of Epidemiology, 5150 Centre Ave., Pittsburgh, PA 15232, USA. Electronic address: yuanj@upmc.edu.
Mindy S KurzerDepartment of Food Science and Nutrition, University of Minnesota, 1334 Eckles Ave., St. Paul, MN 55108, USA. Electronic address: mkurzer@umn.edu.
University of Minnesota · USUPMC Hillman Cancer Center · USAllina Health · USCancer Registry of Norway · NOUniversity of Minnesota Medical Center · USUniversity of Southern California · US

Funding

Women's CancerP30CA077598 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Douglas Yee · 1998 to 2026
$100.4M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
Green Tea and Reduction of Breast Cancer RiskR01CA127236 · NCI · UNIVERSITY OF MINNESOTA · PI KURZER, MINDY SUSAN · 2008 to 2013
$5.7M
Training Program in Nutrition and CancerT32CA132670 · NCI · UNIVERSITY OF MINNESOTA · PI ANDERSON, KRISTIN ELLEN · 2009 to 2013
$1.6M
NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1TR000114NCI NIH HHS P30 CA077598NCI NIH HHS R01 CA127236NCI NIH HHS T32 CA132670NCI NIH HHS T32CA132670
6 · The paper itself

Abstract

Green tea is thought to provide health benefits, though adverse reactions to green tea extract (GTE) have been reported. We conducted a randomized, double-blind, placebo-controlled study of GTE on breast cancer biomarkers, including mammographic density, in which 1075 postmenopausal women were randomly assigned to consume GTE containing 843 mg (-)-epigallocatechin-3-gallate (EGCG) or placebo daily for one year. There were no significant differences in % of women with adverse events (AEs, 75.6% and 72.8% of the GTE group and placebo group, respectively) or serious AEs (2.2 % and 1.5% of GTE and placebo groups, respectively). Women on GTE reported significantly higher incidence of nausea (P < 0.001) and dermatologic AEs (P = 0.05) and significantly lower diarrhea incidence (P = 0.02). More women in the GTE group experienced an alanine aminotransferase (ALT) elevation compared with placebo group (n = 36, (6.7%) vs. n = 4, (0.7%); P < 0.001). There were no statistically significant differences between groups in frequencies of other AEs. Overall, AEs were mainly mild and transient, indicating that daily consumption of GTE containing 843 mg EGCG is generally well tolerated by a group of predominantly Caucasian postmenopausal women. However, 6.7% of GTE consumers experienced ALT elevations, with 1.3% experiencing ALT-related serious AEs.

Indexed as

AgedAnticarcinogenic AgentsAntioxidantsBiomarkersBreast DensityBreast NeoplasmsCamellia sinensisCatechinDietary SupplementsDouble-Blind MethodFemaleFood HandlingHepatic InsufficiencyHumansMammary Glands, HumanMiddle AgedAnticarcinogenic AgentsAntioxidantsBiomarkersCatechinepigallocatechin gallatePlant ExtractsAdverse eventsBreast cancerEGCGGreen teaHepatotoxicityPostmenopausal

Identifiers

PMID26051348
PMCPMC4540665
OpenAlexW563483670

What OpenQuestion holds

Textmetadata
LicenceTDM
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.