The Postprandial Effects of a Carob-containing Meal

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Other: Carob-meal; Other: Non-carob-meal

• Registration Number: NCT06509750
• Lead Sponsor: Harokopio University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Study Start: 2024-08-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-02
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meal_1	Carob-meal	Bread, butter and carob-beverage
Meal_2	Non-carob-meal	bread, butter and beverage with sugar (orange beverage)

Primary Outcome Measures

Name	Time	Method
Plasma ghrelin levels	3 hours	Plasma ghrelin levels in the two groups for the comparison of objective satiety between treatments.
Changes in visual analogue scale	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

Trial Locations

Locations (1)

Andriana Kaliora; 🇬🇷 Athens, Greece