Effect of the Imera Cultivar Carob in Postprandial Glycemia | NCT06906965

Studies
Effect of the Imera Cultivar Carob in Postprandial Glycemia

NCT06906965

Sponsor

Harokopio University

Status

Completed

Last Update Posted

Apr 6, 2025Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Postprandial Glucose Regulation

Interventions

Carob beverage
Sucrose beverage

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
016713	Other Grant/Funding Number	Hellenic Foundation for Research and Innovation

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2024Actual

Primary Completion Date

May 31, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

Mar 26, 2025

First Submission Date that Met QC Criteria

Mar 26, 2025

First Posted Date

Apr 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2025

Last Update Posted Date

Apr 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carob beverage	Experimental	The participants consumed a carob beverage prepared with 30 g of Imera cultivar carob powder dissolved in water	Other: Carob beverage
Sucrose beverage	Active Comparator	The participants consumed a sucrose beverage made containing 14 g of sugar, matched to the sugar concentration of the experimental beverage	Other: Sucrose beverage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carob beverage	Other	The participants consumed a carob beverage made with 30gr of Imera carob cultivar powder in water	Carob beverage

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nutrition and Dietetics, HarokopioUniversity of Athens		Kallithea	Attica	17676	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided