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NCT05870930 | RECRUITING | Healthy Diet


Bioavailability Study of Cretan Carob
Sponsor:

Harokopio University

Information provided by (Responsible Party):

Andriana C Kaliora

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.

Condition or disease

Healthy Diet

Intervention/treatment

Carob beverage

Phase

NA

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, 4-6 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage
Actual Study Start Date : 2024-02-10
Estimated Primary Completion Date : 2024-10-01
Estimated Study Completion Date : 2025-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: 1
Criteria
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

Bioavailability Study of Cretan Carob

Location Details

NCT05870930


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Locations


RECRUITING

Greece,

Andriana Kaliora

Athens, Greece, 17671

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