NCT01142037

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

4 months

First QC Date

June 9, 2010

Last Update Submit

August 21, 2014

Conditions

CancerHealthy

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Urinary Biomarker Results for Dietary Furanocoumarins

    determine the optimal conditions for furanocoumarin identification and quantification in human urine

    Week 1

Secondary Outcomes (1)

  • Mean Concentration of Dietary Furanocoumarin in Urine

    Week 1, 2 and 3

Study Arms (1)

Furanocoumarin

EXPERIMENTAL

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

Interventions

Cooked parsnips with parsleyDIETARY_SUPPLEMENT

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.

Furanocoumarin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be at least 18 years of age
  • Healthy

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science and Nutrition, University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Sabrina Peterson, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 11, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations

US(1)