Obese Subjects, Obesity and Overweight, Overweight/Obesity, Overweight or Obese, Overweight or Obese Adults
Conditions
Keywords
Obesity, Overweight, Polyphenols, Functional food, Randomized controlled trial, Metabolic health
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).
Interventions
DIETARY_SUPPLEMENTPolyphenol-enriched functional product
Polyphenol-enriched functional product
DIETARY_SUPPLEMENTControl without active polyphenols
Product with identical characteristics to the experimental product, but without active polyphenols.
Sponsors
Carmen Lucas Abellán
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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) |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORCarmen Lucas Abellán
Universidad Católica San Antonio de Murcia
Outcome results
None listed