Effect of a Nutritional Product Containing Carob Extract on Carbohydrate Metabolism in Glucose-intolerant Subjects

NCT07420998 | Recruiting DMC

• 1 other identifier: UCAMCFE-00041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, controlled, double-blind clinical trial with two parallel arms based on the product consumed (experimental product and placebo product) and conducted at a single center, to measure the efficacy of the liquid NUTIFOOD product (nutritional product with carob extract) on carbohydrate metabolism.

Conditions

Prediabetes

Keywords

Glucose; Insulin; Carob; Prediabetes

Outcome Measures

Primary Outcomes (2)

• Glycated Hemoglobin (HbA1c)

  Fasting glycated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control.

  Measurements will be performed at baseline, Day 45, and Day 90

• Area Under the Curve (AUC) of Blood Glucose During Oral Glucose Tolerance Test

  The area under the curve (AUC) of blood glucose will be calculated during an oral glucose tolerance test (OGTT) using a 50-g glucose load. Capillary blood glucose levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after glucose ingestion.

  This assessment will be conducted at baseline, Day 45, and Day 90.

Secondary Outcomes (6)

• Fasting and Post-Load Insulinemia

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

• Insulin Resistance

  They will be calculated at the start of the study, on day 45, and on day 90.

• Insulin Sensitivity

  It will be calculated at the start of the study, on day 45, and on day 90.

• Body Composition Analysis

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

• Liver safety variables

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

Study Arms (2)

Carob liquid - GippsNature

EXPERIMENTAL

Participants will consume two daily doses of the experimental product (liquid carob extract) for 90 days.

Dietary Supplement: Experimental Product

Placebo

PLACEBO COMPARATOR

Participants will consume two daily doses of a placebo product with the same organoleptic characteristics as the experimental product for 90 days.

Dietary Supplement: Control product

Interventions

Experimental Product DIETARY_SUPPLEMENT

Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.

Also known as: Carob liquid - GippsNature

Carob liquid - GippsNature

Control product DIETARY_SUPPLEMENT

Participants will consume two daily doses of the placebo product. The product should be taken 30 minutes before the two main meals of the day.

Also known as: Placebo

Placebo

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 18-65 years.
• Diagnosis of glucose intolerance according to the American Diabetes Association (at least one of the following criteria):
• Impaired fasting glucose (100-125 mg/dl)
• Impaired glucose tolerance (oral glucose tolerance test with 2-hour plasma glucose between 140-199 mg/dl)
• Glycated hemoglobin between 5.7% and 6.4%
• Body mass index between 20-35 kg/m².
• Stable dietary habits: no weight gain or loss greater 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 hepatic or renal disease.
• Alcohol consumption greater than 20 g/day.
• History of allergic hypersensitivity or poor tolerance to any component of the study products.
• Participation in another clinical trial within the three months prior to the study.
• Lack of willingness 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, Spain

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Francisco Javier López Román

CONTACT

968278157; jlroman@ucam.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Double-blind study. The organoleptic characteristics of the experimental product and the placebo will be identical.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Controlled, randomized, double-blind clinical trial with two parallel study arms based on the product consumed (placebo or nutritional product containing carob extract) and conducted at a single center.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: February 19, 2026
• Study Start: January 26, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)