Evaluating a Liquid Extract of Carob to Improve Blood Sugar in People With Prediabetes (GLIA)

January 23, 2026 updated by: Francisco Javier López Román, Universidad Católica San Antonio de Murcia

Randomized Clinical Trial to Analyze the Efficacy of a Liquid Carob Extract on the Glucose Metabolism of Subjects With Prediabetes.

This study evaluates whether a liquid carob extract can improve blood glucose levels in individuals with prediabetes. Participants are selected according to predefined health criteria and randomly assigned to two groups: one group receives the carob extract and the other receives an inert liquid (placebo). Blood samples are collected and glucose-related parameters are measured throughout the study to assess changes over time. The objective is to determine whether this extract may contribute to better glycemic control and help prevent progression to diabetes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed to assess the efficacy of a carob extract on glucose metabolism in individuals presenting impaired fasting glucose or elevated glycated hemoglobin levels, without current antidiabetic pharmacological treatment. Participants will consume the extract for 90 days, and metabolic outcomes will be compared with baseline values.

Secondary objectives include assessing changes in glucose area under the curve and peak glucose levels following an oral glucose tolerance test; evaluating variations in fasting glucose and fasting insulin levels after 90 days of intake; and determining changes in peripheral insulin resistance using the HOMA-IR and QUICKI indices. Additionally, potential effects on body composition will be assessed in individuals with abnormal fasting glucose or HbA1c values. Product safety will be monitored and analyzed throughout the study period.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • Murcia, Murcia, Spain, 30107
        • UCAM HiTech, Sport & Health Innovation Hub

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects of both sexes aged between 18 and 65.
  • Diagnosis of prediabetes according to the American Diabetes Association (at least one of the following criteria):
  • Impaired fasting glucose (100-125 mg/dL)
  • Glucose intolerance (oral glucose tolerance test with blood glucose between 140-199 mg/dL after 2 hours).
  • Glycated hemoglobin between 5.7 and 6.4%
  • Subjects with a body mass index between 20-35 kg/m2.
  • Stable eating habits: no weight gain or loss of more than 5 kg in the last ten weeks.
  • Volunteers capable of understanding the clinical study and willing to comply with the study procedures and requirements.

Exclusion Criteria:

  • Use of medications that may interfere with glucose metabolism.
  • Subjects with a history of any type of liver or kidney disease.
  • Alcohol consumption greater than 20 g/day.
  • History of allergic hypersensitivity or poor tolerance to any component of the products under study.
  • Participation in another clinical trial in the three months prior to the study.
  • Unwillingness or inability to comply with clinical trial procedures.
  • Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carob Liquid
Nutritional product: liquid carob extract.
Dietary supplement: Carob extract
Consumo durante 90 días. La dosis diaria del producto es de 6,66 g/día, dividida en dos dosis de 3,33 g/dosis al día. El producto debe tomarse 30 minutos antes de las dos comidas principales del día.
Placebo Comparator: Control group
Nutritional product: placebo
Dietary supplement: Control product
Identical characteristics to the product under study. Consumption for 90 days, twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve (AUC) of blood glucose during the oral glucose tolerance test
Time Frame: This assessment will be performed at baseline, on day 45, and on day 90.
The area under the curve (AUC) of blood glucose during an oral glucose tolerance test (OGTT) with a glucose load of 50 g will be calculated. Capillary blood glucose levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after glucose ingestion.
This assessment will be performed at baseline, on day 45, and on day 90.
Glycosylated hemoglobin (HbA1c)
Time Frame: Measurements will be taken at baseline, on day 45, and on day 90.
Fasting glycosylated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control.
Measurements will be taken at baseline, on day 45, and on day 90.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: At 12 weeks after consumption
It will be evaluated at each of the visits.
At 12 weeks after consumption
Area under the curve (AUC) of blood insulin during the oral glucose tolerance test
Time Frame: This assessment will be performed at the start of the study, on day 45, and on day 90.
The area under the curve (AUC) of insulinemia will be calculated during an oral glucose tolerance test (OGTT) with a glucose load of 50 g. Serum insulin levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after glucose ingestion.
This assessment will be performed at the start of the study, on day 45, and on day 90.
Insulin resistance and insulin sensitivity indices
Time Frame: Both indices will be calculated at baseline, day 45, and day 90.
Peripheral insulin resistance and insulin sensitivity will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) QUICKI (Quantitative Insulin Sensitivity Quotient).
Both indices will be calculated at baseline, day 45, and day 90.
Body composition analysis
Time Frame: These measurements will be taken at the beginning, on day 45, and on day 90.
Body composition will be assessed using bioelectrical impedance analysis (BIA), providing estimates of fat mass, lean mass, and total body water.
These measurements will be taken at the beginning, on day 45, and on day 90.
Liver safety variables
Time Frame: These measurements will be performed at baseline, on day 45, and on day 90.
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
These measurements will be performed at baseline, on day 45, and on day 90.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Investigators

  • Principal Investigator: Fco Javier López Roman, Medical degree, Catholic University of Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCAMCFE-00037

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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