- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509750
The Postprandial Effects of a Carob-containing Meal (ACM)
February 2, 2026 updated by: Andriana C. Kaliora, Harokopio University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Athens, Greece, 17671
- Andriana Kaliora
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy male adults
- normal weight
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meal_1
Bread, butter and carob-beverage
|
A meal with carob-beverage
|
|
Experimental: Meal_2
bread, butter and beverage with sugar (orange beverage)
|
A meal with orange-beverage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma ghrelin levels
Time Frame: 3 hours
|
Plasma ghrelin levels in the two groups for the comparison of objective satiety between treatments.
|
3 hours
|
|
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
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2024
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
July 15, 2024
First Submitted That Met QC Criteria
July 15, 2024
First Posted (Actual)
July 19, 2024
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACM-147
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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