The Postprandial Effects of a Carob-containing Meal

NCT ID: NCT06509750

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2025-05-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Meal_1

Bread, butter and carob-beverage

Group Type: EXPERIMENTAL

Carob-meal

Intervention Type: OTHER

A meal with carob-beverage

Meal_2

bread, butter and beverage with sugar (orange beverage)

Group Type: EXPERIMENTAL

Non-carob-meal

Intervention Type: OTHER

A meal with orange-beverage

Interventions

Carob-meal

A meal with carob-beverage

Intervention Type: OTHER

Non-carob-meal

A meal with orange-beverage

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Harokopio University

OTHER

Sponsor Role: lead

Responsible Party

Andriana C. Kaliora

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Andriana Kaliora

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Facility Contacts

Andriana C Kaliora, Professor

Role: primary

akaliora@hua.gr

+30 2109549226

Other Identifiers

ACM-147

Identifier Type: -

Identifier Source: org_study_id