NCT05870930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

February 10, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 18, 2026

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

May 12, 2023

Last Update Submit

February 16, 2026

Conditions

Healthy Diet

Keywords

carobphenolic compound bioavailabilitymetabolitesbioavailability in humansImera carob

Outcome Measures

Primary Outcomes (1)

  • Identification of putative polyphenol metabolites related to carob consumption.

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

    Six hours

Study Arms (1)

Carob beverage

EXPERIMENTAL
Other: Carob beverage

Interventions

Carob beverageOTHER

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

Carob beverage

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy male adults
  • normal body fat mass

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andriana Kaliora

Athens, 17671, Greece

Location

Study Officials

  • Andriana C Kaliora

    Harokopio University of Athens, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 12, 2023

First Posted

May 23, 2023

Study Start

February 10, 2024

Primary Completion

October 1, 2024

Study Completion

March 1, 2025

Last Updated

February 18, 2026

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)