Overview
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.
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.
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.