Innovative Functional Product for Overweight and Obesity

Carmen Lucas Abellán

Status: Not yet enrolling

Conditions: Overweight/Obesity; Obesity and Overweight; Overweight or Obese Adults; Obese Subjects; Overweight or Obese

Treatments: Dietary Supplement: Polyphenol-enriched functional product; Dietary Supplement: Control without active polyphenols

Study type: Interventional

Funder types: Other

Identifiers

NCT07044167

CE112402

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Daily consumption of the polyphenol-enriched functional product for 60 days.

Treatment:

Dietary Supplement: Polyphenol-enriched functional product

Control

Placebo Comparator group

Description:

Identically appearing placebo capsules consumed for 60 days.

Treatment:

Dietary Supplement: Control without active polyphenols