Bioavailability Trial

NCT06686004 | Completed

• 2 other identifiers: Protocol Carrot-01Not funded
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Carrot is a unique vegetable owing to the availability of bioactive compounds polyacetylenes (PA) as well as carotenoids present in it. These compounds have been shown to be associated with reduced cancer risk in epidemiological-based studies, and also showed anticancer properties in vitro studies and in vivo in mouse and rat models. To investigate whether the PA and carotenoids could have beneficial effects in humans, the present study is designed to determine whether they are detectible in human biofluids after the ingestion of a portion of carrots and whether there is a difference in the magnitude of detection after eating a large (300g) and normal (100g) portion.

Conditions

Absorption, Metabolism and Excretion in Healthy Volunteers; Bioavailability and AUC

Keywords

bioavailability; metabolism; carrots; carotenoids; polyacetylenes; Falcarinol; Falcarindiol; Falcarindiol-3-acetate; α-carotene; β-carotene; lutein; absorption

Outcome Measures

Primary Outcomes (1)

• Absorption of PA and carotenoids

  The primary outcome is testing whether a change in concentration of PA and carotenoids is seen between baseline and various time points in the biofluids after ingesting carrots.

  48hr

Secondary Outcomes (1)

• Dose-effect between the absorption of PA and carotenoids from 100g and 300g carrots

  48hr

Study Arms (2)

High dose (300g) carrot with 2 slices of bread and 10g butter

ACTIVE COMPARATOR

Test Session 2: The participants will consume the 300g carrots with bread and butter. This is considered a reasonable high enough dose that detection of the compounds must occur. This dose would be compared with the normal dose (100g) to see if there is more absorption of the compound when eaten a hiher dose.

Dietary Supplement: Carrots

Experimental: Normal dose (100g) carrot with 2 slices of bread and 10g butter

ACTIVE COMPARATOR

Test session 1: This is a normal dose (100g) which would be compared with the high dose to see if there dose-dependent effect in the magnitude of absorption. Test Session 2: All the process as in the test session 1 will be repeated for the 300g dose carrot.

Dietary Supplement: Carrots

Interventions

Carrots DIETARY_SUPPLEMENT

Detection of polyacetylene and carotenoids in human biofluids

Also known as: PA: falcarinol, falcarindiol, falcarindiol-3-acetate, Carotenoids: α-carotene, β-carotene, lutein

Experimental: Normal dose (100g) carrot with 2 slices of bread and 10g butter; High dose (300g) carrot with 2 slices of bread and 10g butter

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults 20+ years old.
• Having body mass index (BMI) between ≥18.5 - ≤30 kg/m2.
• Must be willing to eat a portion (100g) of carrot in the test session 1, alongside 2 slices of bread with 10g butter.
• Must be willing to eat a portion (300g) of carrot in the test session 2, alongside 2 slices of bread with 10g butter.

You may not qualify if:

• Having any metabolic or gastrointestinal conditions.
• Having allergies to carrot or bread or butter.
• Taking any medication that affects metabolism or digestion.
• Smokers.

Sponsors & Collaborators

• Newcastle University: lead

Study Sites (1)

Nutrtition Suite, DMBB Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE2 4HH, United Kingdom

Location

MeSH Terms

Interventions

falcarindiol; Lutein

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active comparator: orange carrot 100g or 300g Placebo comparator: baseline - before ingestion

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 13, 2024
• Study Start: August 1, 2022
• Primary Completion: August 10, 2023
• Study Completion: September 30, 2024
• Last Updated: November 13, 2024

Record last verified: 2022-08

Locations

GB (1)