Development of a Biomarker for Dietary Furanocoumarins

Certain plant foods are high in furanocoumarins. Test tube and animal studies suggest that furanocoumarins may help prevent cancer. It is difficult to determine in humans if furanocoumarins do prevent cancer because there isn't an objective way to tell who has eaten these compounds. This study will develop a urine test to determine if an individual ate foods that contain furanocoumarins.

Study Overview

• Status: Completed
• Conditions: Healthy; Cancer
• Intervention / Treatment: Dietary supplement: Cooked parsnips with parsley

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • St. Paul, Minnesota, United States, 55108
      • Department of Food Science and Nutrition, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be at least 18 years of age
• Healthy

Exclusion Criteria:

• History of gastrointestinal, hepatic or renal disorder
• Currently taking any prescription or over-the-counter medication
• Currently taking any herbal supplement
• Pregnant or lactating
• Allergies to foods that will be used (parsnips and parsley)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Furanocoumarin; Includes participants first refraining from eating foods with furanocoumarins for one week, followed by 2 weeks of increasing furanocoumarin consumption. Participants will be asked to consume cooked parsnips and parsley.	Dietary supplement: Cooked parsnips with parsley; Beginning on Day 9 participants will be given cooked parsnips with parsley at a dose of 2 grams total apiaceous vegetable/kilogram body weight for period 1, and 4 gram/kilogram body weight for period 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Biomarker Results for Dietary Furanocoumarins	determine the optimal conditions for furanocoumarin identification and quantification in human urine	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Concentration of Dietary Furanocoumarin in Urine	Determine dose response of dietary furanocoumarin in urine - Comparison of Pre-Dose, Low-Dose and High Dose diet of furanocoumarin in subjects' urine collected (ng/ml).	Week 1, 2 and 3

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sabrina Peterson, Ph.D., University of Minnesota

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (Estimate): June 11, 2010

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Healthy volunteer
• Other Study ID Numbers: 2009NTLS107; 0909M72358 (Other Identifier: IRB, University of Minnesota); 1K07CA128952-01A2 (U.S. NIH Grant/Contract)