Clinical Trials Directory

Trials / Completed

CompletedNCT05870930

Bioavailability Study of Cretan Carob

Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Harokopio University · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Accepted

Summary

This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of phenolic compounds of a beverage prepared with Cretan carob powder of the Imera cultivar in healthy individuals after consumption.

Detailed description

This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of active constituents of a beverage with carob powder in healthy individuals after consumption. Fifteen apparently healthy male adults of normal body fat mass (non-obese) will be enrolled based on certain inclusion and exclusion criteria. After enrollment, the volunteers will undergo a medical and dietary assessment and will be instructed to follow a low-phytochemical diet (washout) for five consecutive days, excluding from their diet sources of phytochemicals, i.e., fruits, vegetables, legumes, coffee, tea. Compliance with the low-phytochemical diet will be assessed with a 24 h recall during and at the end of the washout period. On the day of the experiment following washout, volunteers will be given a carob beverage (blood samples will be collected 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0h postprandially). Time intervals 0-6h will be used for LC-ESI-MS/MS approach in order to identify putative polyphenol metabolites related to carob consumption.

Conditions

Interventions

TypeNameDescription
OTHERCarob beverageVolunteers will consume 2 tablespoons of carob powder in 200mL drinking water.

Timeline

Start date
2024-02-10
Primary completion
2024-10-01
Completion
2025-03-01
First posted
2023-05-23
Last updated
2026-02-18

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT05870930. Inclusion in this directory is not an endorsement.