Evidence map›Paper›PMID 32112501›Full record

Trial reportMolecular nutrition & food research2020

Dose-Dependent Increases in Ellagitannin Metabolites as Biomarkers of Intake in Humans Consuming Standardized Black Raspberry Food Products Designed for Clinical Trials.

Kristen M Roberts, Elizabeth M Grainger, Jennifer M Thomas-Ahner, Alice Hinton, Junnan Gu, Ken Riedl, Yael Vodovotz, Ronney Abaza, Steven J Schwartz, Steven K Clinton

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Molecular nutrition & food research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01823562 (Dietary Fruit Bioactives and Prostate Cancer), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
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.

NCT01823562 phase1completednot on this map

Dietary Fruit Bioactives and Prostate Cancer

TypeinterventionalSponsorOhio State University Comprehensive Cancer CenterRan2012 to 2025Enrolled60ConditionsStage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate CancerArmslyophilized black raspberry confection, laboratory biomarker analysis, dietary intervention, quality-of-life assessment, questionnaire administration
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Biomarkers of Berry Intake: Systematic Review Update.Journal of agricultural and food chemistry · 2023
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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

10 authors at 2 institutions in 1 country.

Kristen M RobertsDepartment of Human Sciences, The Ohio State University, Columbus, OH, USA.ORCID 0000-0001-5619-990X
Elizabeth M GraingerComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Jennifer M Thomas-AhnerComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Alice HintonDivision of Biostatistics, The Ohio State University, Columbus, OH, USA.
Junnan GuDepartment of Human Sciences, The Ohio State University, Columbus, OH, USA.
Ken RiedlComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Yael VodovotzComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Ronney AbazaDepartment of Urology, The Ohio State University, Columbus, OH, USA.
Steven J SchwartzComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Steven K ClintonComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
The Ohio State University · USOhioHealth · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
The Ohio State University Center for clinical and Translational ScienceUL1TR001070 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2013 to 2017
$22.6M
Validation studies for interactive omics: Black raspberry metabolites and the oral microbiome in smokersU01CA188250 · NCI · OHIO STATE UNIVERSITY · PI CLINTON, STEVEN K, KUMAR, PURNIMA · 2014 to 2019
$3.6M
The Ohio State University Center for Clinical and Translational Science (KL2)KL2RR025754 · NCRR · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2008 to 2011
$3.5M
NCATS NIH HHS UL1 TR001070NCI NIH HHS P30 CA016058NCI NIH HHS U01 CA188250NCRR NIH HHS KL2 RR025754
6 · The paper itself

Abstract

scopeBlack raspberry (BRB) phytochemicals demonstrate anti-carcinogenic properties in experimental models, including prostate cancer. Two BRB foods, a confection and nectar, providing a consistent and reproducible product for human clinical studies are designed and characterized. METHODS AND

resultsMen with clinically localized prostate cancer are sequentially enrolled to a control group or one of four intervention groups (confection or nectar, 10 or 20 g dose; n = 8 per group) for 4 weeks prior to prostatectomy. Primary outcomes include: safety, adherence, and ellagitannin metabolism. Adherence to the intervention is >96%. No significant (≥grade II) toxicities are detected. Urinary urolithins (A, B, C, and D) and dimethyl ellagic acid (DMEA) quantified by Ultra high performance liquid chromatography tandem mass spectroscopy (UPLC/MS/MS) indicate a dose-dependent excretion yet heterogeneous patterns among men. Men in the BRB confection groups have greater urinary excretion of the microbial urinary metabolites urolithin A and DMEA, suggesting that this food matrix provides greater colonic microflora exposure.

conclusionFully characterized BRB confections and nectar are ideal for food-based large phase III human clinical studies. BRB products provide a bioavailable source of BRB phytochemicals, however large inter individual variation in polyphenol metabolism suggests that host genetics, microflora, and other factors are critical to understanding bioactivity and metabolism.

Indexed as

RubusAgedBiomarkersDose-Response Relationship, DrugHumansHydrolyzable TanninsMaleMiddle AgedProstatic NeoplasmsBiomarkersellagitanninHydrolyzable Tanninsblack raspberriesellagitanninspolyphenol explorer databasepolyphenolsurolithins

Identifiers

PMID32112501
PMCPMC9496378
OpenAlexW3008095560

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.