Development of a Biomarker for Dietary Furanocoumarins

Healthy Clinical Trial

Official title:

Development of a Biomarker for Dietary Furanocoumarins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142037
• Other study ID #: 2009NTLS107
• Secondary ID: 0909M723581K07CA
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: August 21, 2014
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Food Science and Nutrition, University of Minnesota	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Biomarker Results for Dietary Furanocoumarins	determine the optimal conditions for furanocoumarin identification and quantification in human urine	Week 1	No
Secondary	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	No