The Bioavailability of Polyacetylenes From Carrots Study

December 5, 2016 updated by: Newcastle-upon-Tyne Hospitals NHS Trust

Absorption of Naturally Present Compounds in Carrots and Their Appearance in Blood and Other Biofluids After Consumption (The Carrot Study)

Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether the polyacetylenes could have an effect in vivo, this study aims to determine whether they are detectible in human biofluids after the consumption of a portion of carrots and whether a difference is seen between a large and small portion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Volunteers will collect urine samples 24 hours prior to the 'test' day and a stool sample either the night before or the morning of the test session. They will have fasted blood taken before eating a portion of carrots with bread and butter. Further blood samples will be taken at 0.5, 1, 2, 3, 4, 6, 8 and 24 hours. All urine and all stool samples (after 4 hours) will be collected up to 48 hours after the carrot dose. They volunteers will attend two test sessions and will be randomised to receive high and low doses of carrot. At least a week will separate testing sessions.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE6 5HR
        • Clinical Research Facility, Royal Victoria Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults, BMI between 18.5 and 30

Exclusion Criteria:

  • Metabolic or gastrointestinal conditions, allergies to carrot or bread, taking any medication that affects metabolism or digestion, smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Carrot Dose
The volunteer will eat 250g carrot for breakfast with 2 slices of bread and 10g butter
Dietary supplement: Carrot
Other Names:
  • polyacetylene
  • falcarinol
  • falcarindiol
  • falcarindiol-3-acetate
Experimental: Low Carrot Dose
The volunteer will eat 100g of carrot for breakfast with 2 slices of bread and 10g butter
Dietary supplement: Carrot
Other Names:
  • polyacetylene
  • falcarinol
  • falcarindiol
  • falcarindiol-3-acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of polyacetylene in biofluids
Time Frame: 72 hours
The primary outcome will be whether a change in concentration of polyacetylene is seen between baseline and various time points in the biofluids after eating carrots.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of a difference between doses of polyacetylene in biofluids
Time Frame: 72 hours
The secondary outcome will be whether there is a difference between the high and low dose concentrations of polyacetylenes at various time points after eating carrots.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Collaborators

Newcastle University

Investigators

  • Study Director: Sarah Warner, Newcastle University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Carrot_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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