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

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.

Eligibility

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.

Conditions2

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