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

Randomized Clinical Trial on the Effect of a Nutritional Product Containing Carob Extract (NUTIFOOD) on Carbohydrate Metabolism in Glucose-intolerant Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Prediabetes
• Intervention / Treatment: Dietary supplement: Experimental Product; Dietary supplement: Control product

Detailed Description

This study evaluates the effects of NUTIFOOD (liquid nutritional product with carob extract) on insulin sensitivity and carbohydrate metabolism in subjects with abnormal glucose or HbA1c levels not on antidiabetic medication, over 90 days.

Key assessments include: Glucose response (AUC and peak levels) during an oral glucose tolerance test. Changes in fasting glucose, HbA1c, and basal insulin. Insulin resistance measured by HOMA-IR and QUICKI. Effects on body composition. Safety and tolerability of the product.

The study aims to determine the potential of NUTIFOOD as a nutritional intervention to improve glucose regulation and metabolic health.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisco Javier López Román; Phone Number: 157 968278157; Email: jlroman@ucam.edu

Study Locations

• Spain
  • Murcia, Spain
    • Recruiting
    • UCAM HiTech, Sport & Health Innovation Hub
    • Contact: Francisco Javier López Román; Phone Number: 157 968278157; Email: jlroman@ucam.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carob liquid - GippsNature; Participants will consume two daily doses of the experimental product (liquid carob extract) for 90 days.	Dietary supplement: Experimental Product; Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.; Other Names: Carob liquid - GippsNature
Placebo Comparator: Placebo; 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; 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.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	It will be evaluated at each of the visits.	At 12 weeks after consumption
Liver safety variables	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.
Fasting and Post-Load Insulinemia	Fasting venous insulin levels will be measured at baseline. Post-load venous insulin concentrations will be determined at 45 and 90 minutes during the oral glucose tolerance test (50-g glucose load).	These measurements will be performed at baseline, Day 45, and Day 90.
Insulin Resistance	Peripheral insulin resistance will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)	They will be calculated at the start of the study, on day 45, and on day 90.
Insulin Sensitivity	Insulin sensitivity will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: QUICKI (Quantitative Insulin Sensitivity Check Index).	It will be calculated at the start of the study, on day 45, and on day 90.
Body Composition Analysis	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 performed at baseline, Day 45, and Day 90.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Insulin; Prediabetes; Glucose; Carob
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Nutritional and Metabolic Diseases; Insulin Resistance; Prediabetic State; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: UCAMCFE-00041

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