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OpenTrials
Completed

NCT Number: NCT05870930

Bioavailability Study of Cretan Carob

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Andriana Kaliora

Athens, 17671, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carob beverage

Other

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

Primary outcomes

  1. Identification of putative polyphenol metabolites related to carob consumption.

    Time frame: Six hours

    Polyphenol metabolites related to carob consumption identified using LC-ESI-MS/MS.

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Registry information

Official study title

Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage

Acronym: BIOCRETANCAROB

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 23, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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