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The Bioavailability of Polyacetylenes From Carrots Study

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ClinicalTrials.gov Identifier: NCT02696473
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : December 6, 2016
Sponsor:
Collaborator:
Newcastle University
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Carrot Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Absorption of Naturally Present Compounds in Carrots and Their Appearance in Blood and Other Biofluids After Consumption (The Carrot Study)
Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696473


Locations
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United Kingdom
Clinical Research Facility, Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE6 5HR
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle University
Investigators
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Study Director: Sarah Warner Newcastle University
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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02696473    
Other Study ID Numbers: Carrot_01
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Bioavailability
Polyacetylenes
Falcarinol
Falcarindiol
Falcarindiol-3-acetate
Carrot
Biological Availability