ObesityACMNCT06509750
The Postprandial Effects of a Carob-containing Meal
A study testing Carob-meal and Non-carob-meal in people with Obesity, run by Harokopio University at 1 site in Greece.
Trial summary
In an era where malnutrition and unhealthy eating patterns are salient contributors to global health deterioration, the urge for better access to nutritious alimentation is striking. Native to the Mediterranean region, the carob tree holds significant promise in this regard. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Carob-meal and Non-carob-meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 30 Aug 2024to 30 Sep 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male adults
- normal weight
Who cannot join
- high 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
In an era where malnutrition and unhealthy eating patterns are salient contributors to global health deterioration, the urge for better access to nutritious alimentation is striking. Native to the Mediterranean region, the carob tree holds significant promise in this regard. With its rich nutritional profile, containing high levels of dietary fiber, polyphenols, and essential minerals, carob has been increasingly exploited by the food industry. Carob flour, derived from the pod after seed removal, is widely used as a cocoa substitute. The carob tree's fruit comprises 10% seeds and 90% pulp, containing numerous bioactive components such as dietary fiber, cyclitols, phenolic compounds, amino acids, and minerals. These components have been associated with beneficial effects on the gastrointestinal system and glucose absorption, with small-scale clinical studies indicating a hypolipidemic effect in patients with hypolipidemia. Nevertheless, comprehensive data from randomized controlled trials on the biological actions of carob remain restricted. This study explores the postprandial effects of incorporating carob into a Western-style meal, focusing on regulating glucose, insulin, and appetite hormones. The hypothesis is that a carob-enriched breakfast meal could positively influence satiety and appetite regulation, potentially offering a nutritious and sustainable dietary option for improving metabolic health. The high fiber and polyphenol content in carob are expected to modulate these postprandial responses, contributing to a better understanding of carob's role in dietary interventions. This study supports international initiatives to combat malnutrition and encourage a healthy diet, especially in light of the growing world population and the requirement for sustainable food supplies. By investigating the impact of carob on postprandial metabolic responses, this study seeks to contribute valuable insights into its potential benefits as part of a healthy diet.
- Conditions
- Obesity
- Being tested
- Carob-meal, Non-carob-meal
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carob-mealOther
A meal with carob-beverage
Non-carob-mealOther
A meal with orange-beverage
| Study group | Role | What they receive |
|---|---|---|
| Meal_1 | Experimental | Bread, butter and carob-beverage Receives: Other: Carob-meal |
| Meal_2 | Experimental | bread, butter and beverage with sugar (orange beverage) Receives: Other: Non-carob-meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma ghrelin levels
Plasma ghrelin levels in the two groups for the comparison of objective satiety between treatments.
Measured: 3 hours
Changes in visual analogue scale
Changes in visual analogue scale for the comparison of subjective satiety between the two groups. Values range 0-10, the higher the value the higher satiety
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start30 Aug 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andriana C. Kaliora, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509750
- Sponsor's protocol ID
- ACM-147
- Acronym
- ACM
- Status last verified
- Jun 2024
- First submitted
- 15 Jul 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postprandial Effects of a Carob-containing Meal
- ClinicalTrials.gov ID
- NCT06509750
- Acronym / sponsor ID
- ACM / ACM-147
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 19 Jul 2024 (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.
In an era where malnutrition and unhealthy eating patterns are salient contributors to global health deterioration, the urge for better access to nutritious alimentation is striking. Native to the Mediterranean region, the carob tree holds significant promise in this regard. With its rich nutritional profile, containing high levels of dietary fiber, polyphenols, and essential minerals, carob has been increasingly exploited by the food industry. Carob flour, derived from the pod after seed removal, is widely used as a cocoa substitute. The carob tree's fruit comprises 10% seeds and 90% pulp, containing numerous bioactive components such as dietary fiber, cyclitols, phenolic compounds, amino acids, and minerals. These components have been associated with beneficial effects on the gastrointestinal system and glucose absorption, with small-scale clinical studies indicating a hypolipidemic effect in patients with hypolipidemia. Nevertheless, comprehensive data from randomized controlled trials on the biological actions of carob remain restricted. This study explores the postprandial effects of incorporating carob into a Western-style meal, focusing on regulating glucose, insulin, and appetite hormones. The hypothesis is that a carob-enriched breakfast meal could positively influence satiety and appetite regulation, potentially offering a nutritious and sustainable dietary option for improving metabolic health. The high fiber and polyphenol content in carob are expected to modulate these postprandial responses, contributing to a better understanding of carob's role in dietary interventions. This study supports international initiatives to combat malnutrition and encourage a healthy diet, especially in light of the growing world population and the requirement for sustainable food supplies. By investigating the impact of carob on postprandial metabolic responses, this study seeks to contribute valuable insights into its potential benefits as part of a healthy diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal_1 | Experimental | Other: Carob-mealBread, butter and carob-beverage |
| Meal_2 | Experimental | Other: Non-carob-mealbread, butter and beverage with sugar (orange beverage) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy male adults
- normal weight
Key exclusion criteria (1 listed)
- high 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
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-mealA meal with carob-beverage | Other | Meal_1 |
| Non-carob-mealA meal with orange-beverage | Other | Meal_2 |
Primary outcome
Plasma ghrelin levels
Time frame: 3 hours
Plasma ghrelin levels in the two groups for the comparison of objective satiety between treatments.
Changes in visual analogue scale
Time frame: 3 hours
Changes in visual analogue scale for the comparison of subjective satiety between the two groups. Values range 0-10, the higher the value the higher satiety
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 4 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-meal and Non-carob-meal in people with Obesity, 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 1 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 4 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?
Plasma ghrelin levels (time frame: 3 hours). The study lists 2 primary outcomes in all. 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 4 Feb 2026.