Bioavailability Study of Cretan Carob (BIOCRETANCAROB)

Harokopio University

Status: Enrolling

Conditions: Healthy Diet

Treatments: Other: Carob beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT05870930

CRETAN CAROB_147

Details and patient eligibility

About

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.

Full 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, 4-6 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.

Enrollment: 15 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Carob beverage

Experimental group

Treatment:

Other: Carob beverage