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

NCT00578396 | Withdrawn Phase 1 DMC

• 1 other identifier: OCRT07046
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer

Keywords

Grapes and colon cancer prevention

Outcome Measures

Primary Outcomes (1)

• 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

  2 yrs

Secondary Outcomes (3)

• Define whether grape supplemented diet affects colonic mucosa cell proliferation. Ki67 staining method will be utilized on the pre- and post-resveratrol biopsy specimens.

  2 yrs

• Define any side-effects associated with the resveratrol-rich dietary program. Laboratory testing is performed at specified timepoints in this protocol, along with history & physical, for the purposes of toxicity monitoring.

  2 yrs

• Monitor resveratrol content of grapes throughout the course of the study. Grapes will be obtained from the same source as participants monthly throughout the study and the content of resveratrol will be measured.

  2 yrs

Study Arms (3)

Dose Level 1

ACTIVE COMPARATOR

1 lb/day fresh red grapes

Dietary Supplement: grapes

Dose Level 2

ACTIVE COMPARATOR

2/3 lb/day fresh red grapes

Dietary Supplement: grapes

Dose Level 3

ACTIVE COMPARATOR

1/3 lb/day fresh red grapes

Dietary Supplement: grapes

Interventions

grapes DIETARY_SUPPLEMENT

1 pound of seedless red grapes

Also known as: dietary

Dose Level 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older, male or female
• Participants must sign informed consent for enrollment
• Participants must have values for tests included in CBC, CMPAN and UA within normal range or no greater than 1.5x ULN or less than 0.75x LLN at prestudy to proceed to registration
• Participants must have normal limited flexible sigmoidoscopic examination on Day 15 to proceed to re-registration
• To receive Day 28 limited flexible sigmoidoscopy, participants must have taken \>80% of prescribed dose of red grapes (based on food diary review)

You may not qualify if:

• Pregnant or lactating (and/or elevated ßHCG at enrollment)
• Known history of diabetes

Sponsors & Collaborators

• University of California, Irvine: lead
• Gateway for Cancer Research: collaborator

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

grp protein, Drosophila; Diet

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Randall F Holcombe, M.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 21, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

US (1)