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Clinical Trials/NCT05870930
NCT05870930CompletedNot Applicable

Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage

Harokopio University1 site in 1 country15 target enrollmentStarted: February 10, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Identification of putative polyphenol metabolites related to carob consumption.

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Carob beverage

Experimental

Intervention: Carob beverage (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andriana C. Kaliora

Associate Professor

Harokopio University

Study Sites (1)

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