Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870930
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-05-12
Brief Title:
Bioavailability Study of Cretan Carob
Sponsor:
Harokopio University
Organization:
Harokopio University
Study Overview
Official Title:
Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOCRETANCAROB
Brief 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 ie 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 05 10 15 20 25 30 4-6 h postprandially Time intervals 0-6h will be used for LC-ESI-MSMS approach in order to identify putative polyphenol metabolites related to carob consumption
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None