Healthy DietBIOCRETANCAROBNCT05870930
Bioavailability Study of Cretan Carob
A study testing Carob beverage in people with Healthy Diet, run by Harokopio University at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Carob beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- 10 Feb 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male adults
- normal body fat mass
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage
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.
Read the 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.
- Conditions
- Healthy Diet
- Being tested
- Carob beverage
- Keywords
- carob, phenolic compound bioavailability, metabolites, bioavailability in humans, Imera carob
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carob beverageOther
Volunteers will consume 2 tablespoons of carob powder in 200mL drinking water.
| Study group | Role | What they receive |
|---|---|---|
| Carob beverage | Experimental | Not described Receives: Other: Carob beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of putative polyphenol metabolites related to carob consumption.
Polyphenol metabolites related to carob consumption identified using LC-ESI-MS/MS.
Measured: Six hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start10 Feb 2024
- Primary completion1 Oct 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andriana C. Kaliora, Harokopio University
- Investigators
- Andriana C Kaliora, Principal investigator, Harokopio University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870930
- Sponsor's protocol ID
- CRETAN CAROB_147
- Acronym
- BIOCRETANCAROB
- Status last verified
- Mar 2024
- First submitted
- 12 May 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage
- ClinicalTrials.gov ID
- NCT05870930
- Acronym / sponsor ID
- BIOCRETANCAROB / CRETAN CAROB_147
- Conditions
- Healthy Diet
- Keywords
- carob, phenolic compound bioavailability, metabolites, bioavailability in humans, Imera carob
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carob beverage | Experimental | Other: Carob beverage |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy male adults
- normal body fat mass
Key exclusion criteria (7 listed)
- obesity (according to body fat mass)
- Type 1 Diabetes, cardiovascular diseases, hypertension
- thyroid disorder, liver disease, kidney disease
- gastrointestinal disease
- mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carob beverageVolunteers will consume 2 tablespoons of carob powder in 200mL drinking water. | Other | Carob beverage |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andriana C Kaliora principal investigator
Harokopio University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carob beverage in people with Healthy Diet, run by Harokopio University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of putative polyphenol metabolites related to carob consumption. (time frame: Six hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.