Bioavailability Study of Cretan Carob (BIOCRETANCAROB)

Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage

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.

Study Overview

• Status: Completed
• Conditions: Healthy Diet
• Intervention / Treatment: Other: Carob beverage

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 17671
    • Andriana Kaliora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy male adults
• normal body fat mass

Exclusion Criteria:

• obesity (according to body fat mass)
• Type 1 Diabetes, cardiovascular diseases, hypertension
• thyroid disorder, liver disease, kidney disease
• gastrointestinal disease
• mental illness
• use of nutraceutical supplements or natural products for weight loss
• dietitians/nutritionists

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carob beverage	Other: Carob beverage; Volunteers will consume 2 tablespoons of carob powder in 200mL drinking water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of putative polyphenol metabolites related to carob consumption.	Polyphenol metabolites related to carob consumption identified using LC-ESI-MS/MS.	Six hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigation of the associations of the metabolic profile of the volunteers to the appetite modulation and satiety.	Metabolic profile of the volunteers as assessed by LC-ESI-MS/MS will be evaluated for potential associations with appetite modulation and satiety.	Three hours
Weight/quantity of food remaining after consumption.	The weight/quantity of food remaining after consumption for the comparison of objective satiety between the two groups.	Three hours
Plasma ghrelin levels	Plasma ghrelin levels in the two groups for the comparison of objective satiety between treatments.	Three hours
Identification of putative polyphenol metabolites related to carob consumption.	Polyphenol metabolites related to carob consumption identified using LC-ESI-MS/MS.	Three hours

Collaborators and Investigators

• Sponsor: Harokopio University
• Investigators: Principal Investigator: Andriana C Kaliora, Harokopio University of Athens, Greece

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: metabolites; carob; phenolic compound bioavailability; bioavailability in humans; Imera carob
• Other Study ID Numbers: CRETAN CAROB_147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No