Innovative Functional Product for Overweight and Obesity

NCT07044167 | Completed

• 1 other identifier: CE112402
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Obesity; Overweight; Polyphenols; Functional food; Randomized controlled trial; Metabolic health

Outcome Measures

Primary Outcomes (4)

• Change in Body Weight

  Evaluation of differences in body weight (kg)

  Day 1 and Day 60

• Change in fat mass

  Evaluation of differences in fat mass (kg)

  Day 1 and Day 60

• Change in fat mass (%)

  Evaluation of differences in fat mass percentage (%)

  Day 1 and Day 60

• Change in Body Mass Index (BMI)

  BMI will be calculated from measured weight and height using the formula weight (kg) / height² (m²).

  Day 1 and Day 60

Secondary Outcomes (13)

• Change in fasting glucose

  Day 1 and Day 60.

• Change in fasting insulin

  Day 1 and Day 60.

• Change in plasma leptin levels

  Day 1 and Day 60

• Change in plasma ghrelin levels

  Day 1 and Day 60

• Change in plasma adiponectin levels

  Day 1 and Day 60

Study Arms (2)

Experimental

EXPERIMENTAL

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

Dietary Supplement: Polyphenol-enriched functional product

Control

PLACEBO COMPARATOR

Identically appearing placebo capsules consumed for 60 days.

Dietary Supplement: Control without active polyphenols

Interventions

Polyphenol-enriched functional product DIETARY_SUPPLEMENT

Polyphenol-enriched functional product

Experimental

Control without active polyphenols DIETARY_SUPPLEMENT

Product with identical characteristics to the experimental product, but without active polyphenols.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carmen Lucas Abellán: lead
• Universidad Católica San Antonio de Murcia: collaborator

Study Sites (1)

UCAM San Antonio Catholic University of Murcia, Murcia, Murcia 30107

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmen Lucas Abellán

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 29, 2025
• Study Start: September 7, 2025
• Primary Completion: November 24, 2025
• Study Completion: December 19, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

ES (1)