The Bioavailability of Polyacetylenes From Carrots Study

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Carrot

• Registration Number: NCT02696473
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-02-25
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-02
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Carrot Dose	Carrot	The volunteer will eat 250g carrot for breakfast with 2 slices of bread and 10g butter
Low Carrot Dose	Carrot	The volunteer will eat 100g of carrot for breakfast with 2 slices of bread and 10g butter

Primary Outcome Measures

Name	Time	Method
Detection of polyacetylene in biofluids	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

Name	Time	Method
Detection of a difference between doses of polyacetylene in biofluids	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.

Trial Locations

Locations (1)

Clinical Research Facility, Royal Victoria Infirmary; 🇬🇧 Newcastle upon Tyne, United Kingdom