NCT02696473

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

February 25, 2016

Last Update Submit

December 5, 2016

Conditions

Healthy

Keywords

BioavailabilityPolyacetylenesFalcarinolFalcarindiolFalcarindiol-3-acetateCarrotBiological Availability

Outcome Measures

Primary Outcomes (1)

  • Detection of polyacetylene in biofluids

    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 Outcomes (1)

  • Detection of a difference between doses of polyacetylene in biofluids

    72 hours

Study Arms (2)

High Carrot Dose

EXPERIMENTAL

The volunteer will eat 250g carrot for breakfast with 2 slices of bread and 10g butter

Dietary Supplement: Carrot

Low Carrot Dose

EXPERIMENTAL

The volunteer will eat 100g of carrot for breakfast with 2 slices of bread and 10g butter

Dietary Supplement: Carrot

Interventions

CarrotDIETARY_SUPPLEMENT
Also known as: polyacetylene, falcarinol, falcarindiol, falcarindiol-3-acetate
High Carrot DoseLow Carrot Dose

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults, BMI between 18.5 and 30

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Facility, Royal Victoria Infirmary

Newcastle upon Tyne, NE6 5HR, United Kingdom

Location

MeSH Terms

Interventions

Polyynesfalcarinolfalcarindiol

Intervention Hierarchy (Ancestors)

AlkynesHydrocarbons, AcyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sarah Warner

    Newcastle University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 2, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)