The Postprandial Effects of a Carob-containing Meal

NCT06509750 | Completed

• 1 other identifier: ACM-147
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Plasma ghrelin levels

  Plasma ghrelin levels in the two groups for the comparison of objective satiety between treatments.

  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

  3 hours

Study Arms (2)

Meal_1

EXPERIMENTAL

Bread, butter and carob-beverage

Other: Carob-meal

Meal_2

EXPERIMENTAL

bread, butter and beverage with sugar (orange beverage)

Other: Non-carob-meal

Interventions

Carob-meal OTHER

A meal with carob-beverage

Meal_1

Non-carob-meal OTHER

A meal with orange-beverage

Meal_2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male adults
• normal weight

You may not qualify if:

• 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

Sponsors & Collaborators

• Harokopio University: lead

Study Sites (1)

Andriana Kaliora

Athens, 17671, Greece

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: August 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 4, 2026

Record last verified: 2024-06

Locations

GR (1)