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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Francisco Javier López Román
• Email: jlroman@ucam.edu
• Phone: 968278157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.