Bioavailability Trial

NCT ID: NCT06686004

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-09-30

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.

Detailed Description

The occurrence of PA and carotenoids in carrot is not a guaranteed that they have potential health benefits and biological activity in humans, as there is still insufficient knowledge as to whether they can be absorbed in human bio-fluids (blood, urine and faeces) after the food (carrot) is consumed in the literature. The bioavailability of compounds depends upon both the chemical forms and physical structures which enable a certain proportion of such compounds into circulation when introduced into the body and so are able to have an active effect.

The main goal of this trial is to investigate determine the fate of (PAs and carotenoids) found in carrots human plasma, urine and faeces.

To achieve this goal, health adult volunteers will be instructed to restrict their diet (To avoid eating food that contain the compounds of interest) for 48hrs and complete 24hr food diary.

They will fast overnight and collect urine and faecal samples on the morning of the test session. Once they arrive in the research facility, they will have fasted blood taken before eating a portion of carrots (either 100 or 300g) with bread and butter. Further blood samples will be taken at 1, 2, 4, 6, 8 and 24 hours. Urine sample will be collected at 4, 8, 12 and 24hr and up to 48hr after the carrot consumption, and faecal samples will be collected at any time the participants feel bowel movement during the study duration up to 48hr, noting the time when each sample was generated.

The participants will attend two test sessions and will be randomised to receive high (300g) and normal (100g) doses of carrot. The washout period separating the two testing sessions is at least a week.

The specific compounds of interest in this trial include PA (falcarinol, falcarindiol, and falcarindiol 3-acetate), carotenoids (α-carotene, β-carotene and lutein) and their concentrations at various time points after consumption and baseline will be measured using HPLC (for carotenoids) and LC-MS (for PA). The concentrations of the compounds at time points after ingestion will be compared with the baseline and also in relation to, normal and high carrot doses.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

Carrots

Intervention Type: DIETARY_SUPPLEMENT

Detection of polyacetylene and carotenoids in human biofluids

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

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.

Group Type: ACTIVE_COMPARATOR

Carrots

Intervention Type: DIETARY_SUPPLEMENT

Detection of polyacetylene and carotenoids in human biofluids

Interventions

Carrots

Detection of polyacetylene and carotenoids in human biofluids

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

PA: falcarinol, falcarindiol, falcarindiol-3-acetate; Carotenoids: α-carotene, β-carotene, lutein

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Newcastle University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nutrtition Suite, DMBB Newcastle University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Countries

United Kingdom

Other Identifiers

Not funded

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Carrot-01

Identifier Type: -

Identifier Source: org_study_id