NCT00578396

Phase I Biomarker Study of Dietary Grape-derived Low Dose Resveratrol for Colon Cancer Prevention

Withdrawn Phase 1 Last updated 22 January 2021

What this trial tests

Phase 1 trial testing grapes in Colon Cancer. Withdrawn.

Timeline

1 December 2007

Primary endpoint
1 December 2007

1 December 2007

Quick facts

Lead sponsor	University of California, Irvine
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Start date	1 December 2007
Primary completion	1 December 2007
Estimated completion	1 December 2007
Sites	1 location across United States

Drugs / interventions tested

• grapes
• grapes
• grapes

Conditions studied

• Colon Cancer — all drugs for Colon Cancer →

Sponsor

University of California, Irvine

Who can join

18 and older, any sex, with Colon Cancer. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Expression and cellular localization of beta-catenin in intestinal mucosa: localization of β-catenin. Expression of Wnt pathway target genes in intestinal mucosa: Wnt target gene expression
  Time frame: 2 yrs

Sponsor's own description

This study is designed to investigate the dietary influence of grapes in colon cancer prevention. A natural compound found in the skin of grapes, resveratrol, may protect against cancer by acting as an antioxidant (a chemical compound or substance that helps reduce damages due to oxygen). This compound is known to block colon cancer cell lines from growing in the laboratory. The purpose of this study is to determine the minimum amount of resveratrol-rich fresh red grapes needed to exhibit such signs of prevention.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perspectives for cancer prevention with natural compounds.
   Amin AR, Kucuk O, Khuri FR, Shin DM. · · 2009 · cited 330× · PMID 19414669 · DOI 10.1200/jco.2008.20.6235
2. Plant-Derived Anticancer Compounds as New Perspectives in Drug Discovery and Alternative Therapy.
   Dehelean CA, Marcovici I, Soica C, Mioc M, et al · · 2021 · cited 244× · PMID 33669817 · DOI 10.3390/molecules26041109
3. Anticancer Molecular Mechanisms of Resveratrol.
   Varoni EM, Lo Faro AF, Sharifi-Rad J, Iriti M. · · 2016 · cited 231× · PMID 27148534 · DOI 10.3389/fnut.2016.00008
4. Emerging role of lipid metabolism alterations in Cancer stem cells.
   Yi M, Li J, Chen S, Cai J, et al · · 2018 · cited 182× · PMID 29907133 · DOI 10.1186/s13046-018-0784-5
5. Resveratrol and cancer: Challenges for clinical translation.
   Singh CK, Ndiaye MA, Ahmad N. · · 2015 · cited 176× · PMID 25446990 · DOI 10.1016/j.bbadis.2014.11.004
6. Wnt signaling and colon carcinogenesis: beyond APC.
   Najdi R, Holcombe RF, Waterman ML. · · 2011 · cited 146× · PMID 21483657 · DOI 10.4103/1477-3163.78111
7. Resveratrol suppresses growth of cancer stem-like cells by inhibiting fatty acid synthase.
   Pandey PR, Okuda H, Watabe M, Pai SK, et al · · 2011 · cited 142× · PMID 21188630 · DOI 10.1007/s10549-010-1300-6
8. Phytochemicals in Cancer Treatment and Cancer Prevention-Review on Epidemiological Data and Clinical Trials.
   Rudzińska A, Juchaniuk P, Oberda J, Wiśniewska J, et al · · 2023 · cited 89× · PMID 37111115 · DOI 10.3390/nu15081896