Effect of the Imera Cultivar Carob in Postprandial Glycemia (IMERACAROBGLUC)

Impact of the Imera Carob Cultivar in Postprandial Glycemia

An acute randomized crossover study on the effect of a carob beverage on postprandial glycemic response

Study Overview

• Status: Completed
• Conditions: Postprandial Glucose Regulation
• Intervention / Treatment: Other: Carob beverage; Other: Sucrose beverage

Detailed Description

This is an acute randomized crossover study on the effect of an Imera cultivar carob beverage on postprandial glycemic response in healthy individuals as opposed to sucrose-based beverage containing sugar in alike concentration

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Kallithea, Attica, Greece, 17676
      • Department of Nutrition and Dietetics, HarokopioUniversity of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy male adults of normal body fat mass

Exclusion Criteria:

• obesity (according to body fat mass), type 1 Diabetes, hypertension and other cardiovascular diseases, thyroid disorder, liver, kidney, gastrointestinal disease, mental illness, use of nutraceutical supplements or natural products for weight loss and the background of dietitian/nutritionist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carob beverage; The participants consumed a carob beverage prepared with 30 g of Imera cultivar carob powder dissolved in water	Other: Carob beverage; The participants consumed a carob beverage made with 30gr of Imera carob cultivar powder in water
Active Comparator: Sucrose beverage; The participants consumed a sucrose beverage made containing 14 g of sugar, matched to the sugar concentration of the experimental beverage	Other: Sucrose beverage; The participants consumed a sucrose beverage made with 14gr of sugar in alike concentration with sugars in the experimental beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glucose	Changes in glucose levels after the consumption of the beverage	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial insulin	Changes in insulin levels after consuming the beverage	3 hours

Collaborators and Investigators

• Sponsor: Harokopio University

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: carob powder; postprandial glucose; glucose regulation; carob; postprandial insulin
• Other Study ID Numbers: CAROB_GLUCOSE_147; 016713 (Other Grant/Funding Number: Hellenic Foundation for Research and Innovation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No