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Completed

NCT Number: NCT07044167

Innovative Functional Product for 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.

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Key information

Conditions

Obesity and Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Subjects Obesity Overnutrition Overweight Overweight or Obese Overweight or Obese Adults Overweight/Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Murcia, 30107, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polyphenol-enriched functional product

Dietary Supplement

Polyphenol-enriched functional product

Control without active polyphenols

Dietary Supplement

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

Primary outcomes

  1. Change in Body Weight

    Time frame: Day 1 and Day 60

    Evaluation of differences in body weight (kg)

  2. Change in fat mass

    Time frame: Day 1 and Day 60

    Evaluation of differences in fat mass (kg)

  3. Change in fat mass (%)

    Time frame: Day 1 and Day 60

    Evaluation of differences in fat mass percentage (%)

  4. Change in Body Mass Index (BMI)

    Time frame: Day 1 and Day 60

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

Secondary outcomes

  1. Change in fasting glucose

    Time frame: Day 1 and Day 60.

    Assessment of changes in fasting glucose levels (mg/dL)

  2. Change in fasting insulin

    Time frame: Day 1 and Day 60.

    Assessment of changes in insulin levels.

  3. Change in plasma leptin levels

    Time frame: Day 1 and Day 60

    Leptin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).

  4. Change in plasma ghrelin levels

    Time frame: Day 1 and Day 60

    Ghrelin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL).

  5. Change in plasma adiponectin levels

    Time frame: Day 1 and Day 60

    Adiponectin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL).

  6. Change in plasma SOCS3 levels

    Time frame: Day 1 and Day 60

    SOCS3 levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).

  7. Change in plasma interleukin-1 (IL-1β) levels

    Time frame: Day 1 and Day 60

    Interleukin-1 (IL-1β) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).

  8. Change in plasma interleukin-6 (IL-6) levels

    Time frame: Day 1 and Day 60

    Interleukin-6 (IL-6) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).

  9. Change in plasma interleukin-10 (IL-10) levels

    Time frame: Day 1 and Day 60

    Interleukin-10 (IL-10) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).

  10. Change in plasma oxidized LDL (oxLDL) levels

    Time frame: Day 1 and Day 60

    Oxidized LDL (oxLDL) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).

  11. Change in plasma malondialdehyde (MDA) levels

    Time frame: Day 1 and Day 60

    Malondialdehyde (MDA) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL).

  12. Change in plasma superoxide dismutase (SOD) levels

    Time frame: Day 1 and Day 60

    superoxide dismutase (SOD) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).

  13. Changes in C-reactive protein (CRP)

    Time frame: Day 1 and Day 60

    Measurement of changes in C-reactive protein (mg/L)

Sponsors and collaborators

Lead sponsor

Carmen Lucas Abellán

Other

Collaborators

  • Universidad Católica San Antonio de Murcia

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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