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

NCT07379931 | Not Yet Recruiting

• 1 other identifier: UCAMCFE-00037
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Keywords

Prediabetes; Glucose; Carob; Placebo

Outcome Measures

Primary Outcomes (2)

• Area under the curve (AUC) of blood glucose during the oral glucose tolerance test

  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)

  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 Outcomes (5)

• Area under the curve (AUC) of blood insulin during the oral glucose tolerance test

  This assessment will be performed at the start of the study, on day 45, and on day 90.

• Insulin resistance and insulin sensitivity indices

  Both indices will be calculated at baseline, day 45, and day 90.

• Body composition analysis

  These measurements will be taken at the beginning, on day 45, and on day 90.

• Liver safety variables

  These measurements will be performed at baseline, on day 45, and on day 90.

• Adverse events

  At 12 weeks after consumption

Study Arms (2)

Carob Liquid

EXPERIMENTAL

Nutritional product: liquid carob extract.

Dietary Supplement: Carob extract

Control group

PLACEBO COMPARATOR

Nutritional product: placebo

Dietary Supplement: Control product

Interventions

Carob extract DIETARY_SUPPLEMENT

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.

Carob Liquid

Control product DIETARY_SUPPLEMENT

Identical characteristics to the product under study. Consumption for 90 days, twice a day.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

UCAM HiTech, Sport & Health Innovation Hub

Murcia, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Glucose Intolerance

Interventions

locust bean gum; Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Fco Javier López Roman, Medical degree

  Catholic University of Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical degree

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 2, 2026
• Study Start: January 1, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)