Innovative Functional Product for Overweight and Obesity

NCT ID: NCT07044167

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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

Keywords

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Obesity Overweight Polyphenols Functional food Randomized controlled trial Metabolic health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Polyphenol-enriched functional product

Intervention Type DIETARY_SUPPLEMENT

Polyphenol-enriched functional product

Control

Identically appearing placebo capsules consumed for 60 days.

Group Type PLACEBO_COMPARATOR

Control without active polyphenols

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Polyphenol-enriched functional product

Polyphenol-enriched functional product

Intervention Type DIETARY_SUPPLEMENT

Control without active polyphenols

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role collaborator

Carmen Lucas Abellán

OTHER

Sponsor Role lead

Responsible Party

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Carmen Lucas Abellán

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carmen Lucas Abellán

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio de Murcia

Locations

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

Murcia, , Spain

Site Status

Countries

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Spain

Central Contacts

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Carmen Lucas Abellán

Role: CONTACT

Phone: +349682785523

Email: [email protected]

Universidad Católica San Antonio de Murcia

Role: CONTACT

Phone: +34968278800

Facility Contacts

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San Antonio Catholic University of Murcia UCAM

Role: primary

Other Identifiers

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CE112402

Identifier Type: -

Identifier Source: org_study_id