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

Condition(s) studied

Investigational drug(s) / intervention(s)

Experimental Product: Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.

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.

Study 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

Primary outcome measure(s)

• Glycated Hemoglobin (HbA1c) — Measurements will be performed at baseline, Day 45, and Day 90
  Fasting glycated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control.
• Area Under the Curve (AUC) of Blood Glucose During Oral Glucose Tolerance Test — This assessment will be conducted at baseline, Day 45, and Day 90.
  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.

Trial sites (1)

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