NCT06906965

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 26, 2025

Last Update Submit

April 4, 2025

Conditions

Keywords

postprandial glucoseglucose regulationcarobcarob powderpostprandial insulin

Outcome Measures

Primary Outcomes (1)

  • Postprandial glucose

    Changes in glucose levels after the consumption of the beverage

    3 hours

Secondary Outcomes (1)

  • Postprandial insulin

    3 hours

Study Arms (2)

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

The participants consumed a carob beverage made with 30gr of Imera carob cultivar powder in water

Carob beverage

The participants consumed a sucrose beverage made with 14gr of sugar in alike concentration with sugars in the experimental beverage

Sucrose beverage

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy male adults of normal body fat mass

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition and Dietetics, HarokopioUniversity of Athens

Kallithea, Attica, 17676, Greece

Location

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

March 26, 2025

First Posted

April 2, 2025

Study Start

January 31, 2024

Primary Completion

May 31, 2024

Study Completion

September 30, 2024

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations