Innovative Functional Product for Overweight and Obesity

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07044167
• Lead Sponsor: Carmen Lucas Abellán

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2025-05-20
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Study Start: 2025-09-01
• Primary Completion: 2025-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	Day 1 and Day 60	Evaluation of differences in body weight (kg)
Change in fat mass	Day 1 and Day 60	Evaluation of differences in fat mass (kg)
Change in fat mass (%)	Day 1 and Day 60	Evaluation of differences in fat mass percentage (%)
Change in Body Mass Index (BMI)	Day 1 and Day 60	BMI will be calculated from measured weight and height using the formula weight (kg) / height² (m²).

Secondary Outcome Measures

Name	Time	Method
Change in plasma adiponectin levels	Day 1 and Day 60	Adiponectin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL).
Change in plasma SOCS3 levels	Day 1 and Day 60	SOCS3 levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).
Change in fasting glucose	Day 1 and Day 60.	Assessment of changes in fasting glucose levels (mg/dL)
Change in fasting insulin	Day 1 and Day 60.	Assessment of changes in insulin levels.
Change in plasma leptin levels	Day 1 and Day 60	Leptin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).
Change in plasma ghrelin levels	Day 1 and Day 60	Ghrelin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL).
Change in plasma interleukin-1 (IL-1β) levels	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).
Change in plasma interleukin-6 (IL-6) levels	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).
Change in plasma interleukin-10 (IL-10) levels	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).
Change in plasma oxidized LDL (oxLDL) levels	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).
Change in plasma malondialdehyde (MDA) levels	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).
Change in plasma superoxide dismutase (SOD) levels	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).
Changes in C-reactive protein (CRP)	Day 1 and Day 60	Measurement of changes in C-reactive protein (mg/L)

Trial Locations

Locations (1)

UCAM San Antonio Catholic University of Murcia, Murcia, Murcia 30107; 🇪🇸 Murcia, Spain