Innovative Functional Product for Overweight and Obesity

Development of a Novel Polyphenol-Enriched Functional Product for the Treatment of Overweight and Obesity

The aim of this randomized, parallel, two-arm, placebo-controlled, quadruple-blind clinical trial is to evaluate the efficacy of a polyphenol-enriched functional product in individuals with overweight or obesity, focusing primarily on body composition, insulin sensitivity, inflammatory markers, and other metabolic health parameters.

The duration of the study will be 60 days during which the investigational product or placebo will be consumed daily according to the assignment.

Subjects will be randomized to each of the study arms (consumption of the polyphenol-enriched product or control product).

Inclusion Criteria:

• Individuals of both sexes, aged 18 years or older.
• Body Mass Index (BMI) between 25 and 35.
• Clinical diagnosis of overweight or obesity according to established criteria.
• Ability to understand and sign the informed consent form.

Exclusion Criteria:

• Presence of severe or terminal chronic diseases.
• Current treatment with antioxidants or similar dietary supplements.
• Known allergies to any of the product components.
• Pregnancy or breastfeeding.
• Participation in another clinical trial within the past 3 months.