Bioavailability Study of Cretan Carob

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-10

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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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, 4-6 h 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

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Healthy Diet

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Carob beverage

Group Type EXPERIMENTAL

Carob beverage

Intervention Type OTHER

Volunteers will consume 2 tablespoons of carob powder in 200mL drinking water.

Interventions

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Carob beverage

Volunteers will consume 2 tablespoons of carob powder in 200mL drinking water.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes