Liquid nutritional product with carob extract to improve carbohydrate metabolism in people with prediabetes.

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

This 90-day test will see if a liquid nutritional product containing carob extract can help improve blood sugar control in adults with prediabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Universidad Católica San Antonio de Murcia (Academic / other)
• Locations: 1 site (Murcia)
• Trial ID: NCT07420998 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled trial will compare a liquid nutritional product containing carob extract to a matching placebo over 90 days in adults with glucose intolerance. Eligible participants are 18–65 years old with impaired fasting glucose, impaired glucose tolerance, or HbA1c 5.7–6.4% and BMI 20–35 kg/m², and are not taking antidiabetic medications. Primary outcomes include glucose response during an oral glucose tolerance test (AUC and peak), changes in fasting glucose, HbA1c, basal insulin, and insulin resistance indices (HOMA-IR, QUICKI); body composition and safety/tolerability will also be recorded. The single-center study is conducted at UCAM HiTech in Murcia, Spain with scheduled metabolic testing and follow-up visits.

Who should consider this trial

Good fit: Adults aged 18–65 with prediabetes (impaired fasting glucose, impaired glucose tolerance, or HbA1c 5.7–6.4%), BMI 20–35 kg/m², stable weight, and not taking antidiabetic medications are the intended participants.

Not a fit: People taking medications that affect glucose metabolism, those with liver or kidney disease, heavy alcohol use, known allergy to product components, recent trial participation, or who fall outside the age/BMI limits are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this could offer a safe, non-drug option to help lower blood sugar and reduce insulin resistance in people with prediabetes.

How similar studies have performed: Small human and animal studies of carob extracts or fiber-rich carob products have suggested modest improvements in postprandial glucose, but large randomized trials in prediabetes are limited.

Eligibility criteria

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.

Where this trial is running

Murcia

• UCAM HiTech, Sport & Health Innovation Hub — Murcia, Spain (Recruiting)

Study contacts

• Study coordinator: Francisco Javier López Román

Conditions Prediabetes; Glucose; Insulin; Carob