Obesity and OverweightNCT07044167
Innovative Functional Product for Overweight and Obesity
A study testing Polyphenol-enriched functional product in people with Obesity and Overweight and Overweight or Obese, run by Carmen Lucas Abellán at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Overweight, Overweight or Obese, Overweight or Obese Adults
- What is being tested?
- Polyphenol-enriched functional product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 7 Sep 2025to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
UCAM San Antonio Catholic University of Murcia, Murcia, Murcia 30107
Murcia, 30107
About this study
Official title: Development of a Novel Polyphenol-Enriched Functional Product for the Treatment of 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.
Read the 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).
- Conditions
- Obesity and Overweight, Overweight or Obese, Overweight or Obese Adults, Obese Subjects, Overweight/Obesity
- Being tested
- Polyphenol-enriched functional product, Control without active polyphenols
- Keywords
- Obesity, Overweight, Polyphenols, Functional food, Randomized controlled trial, Metabolic health
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol-enriched functional productDietary supplement
Polyphenol-enriched functional product
Control without active polyphenolsDietary supplement
Product with identical characteristics to the experimental product, but without active polyphenols.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Daily consumption of the polyphenol-enriched functional product for 60 days. Receives: Dietary Supplement: Polyphenol-enriched functional product |
| Control | Placebo comparator | Identically appearing placebo capsules consumed for 60 days. Receives: Dietary Supplement: Control without active polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Evaluation of differences in body weight (kg)
Measured: Day 1 and Day 60
Change in fat mass
Evaluation of differences in fat mass (kg)
Measured: Day 1 and Day 60
Change in fat mass (%)
Evaluation of differences in fat mass percentage (%)
Measured: 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).
Measured: Day 1 and Day 60
Secondary outcomes (13)
Change in fasting glucose
Assessment of changes in fasting glucose levels (mg/dL)
Measured: Day 1 and Day 60.
Change in fasting insulin
Assessment of changes in insulin levels.
Measured: Day 1 and Day 60.
Change in plasma leptin levels
Leptin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).
Measured: Day 1 and Day 60
Change in plasma ghrelin levels
Ghrelin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL).
Measured: Day 1 and Day 60
Change in plasma adiponectin levels
Adiponectin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL).
Measured: Day 1 and Day 60
Change in plasma SOCS3 levels
SOCS3 levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).
Measured: Day 1 and Day 60
Change in plasma interleukin-1 (IL-1β) levels
Interleukin-1 (IL-1β) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).
Measured: Day 1 and Day 60
Change in plasma interleukin-6 (IL-6) levels
Interleukin-6 (IL-6) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).
Measured: Day 1 and Day 60
Change in plasma interleukin-10 (IL-10) levels
Interleukin-10 (IL-10) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).
Measured: Day 1 and Day 60
Change in plasma oxidized LDL (oxLDL) levels
Oxidized LDL (oxLDL) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).
Measured: Day 1 and Day 60
Change in plasma malondialdehyde (MDA) levels
Malondialdehyde (MDA) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL).
Measured: Day 1 and Day 60
Change in plasma superoxide dismutase (SOD) levels
superoxide dismutase (SOD) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL).
Measured: Day 1 and Day 60
Changes in C-reactive protein (CRP)
Measurement of changes in C-reactive protein (mg/L)
Measured: Day 1 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start7 Sep 2025
- Primary completion24 Nov 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmen Lucas Abellán
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia
- Responsible party
- Sponsor-investigator, Carmen Lucas Abellán, Universidad Católica San Antonio de Murcia
- Investigators
- Carmen Lucas Abellán, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044167
- Sponsor's protocol ID
- CE112402
- Status last verified
- Feb 2026
- First submitted
- 20 May 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Polyphenol-Enriched Functional Product for the Treatment of Overweight and Obesity
- ClinicalTrials.gov ID
- NCT07044167
- Acronym / sponsor ID
- CE112402
- Conditions
- Obesity and Overweight, Overweight or Obese, Overweight or Obese Adults, Obese Subjects, Overweight/Obesity
- Keywords
- Obesity, Overweight, Polyphenols, Functional food, Randomized controlled trial, Metabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Carmen Lucas AbellánUniversity, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia
- Study start
- 7 Sep 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Polyphenol-enriched functional productDaily consumption of the polyphenol-enriched functional product for 60 days. |
| Control | Placebo comparator | Dietary Supplement: Control without active polyphenolsIdentically appearing placebo capsules consumed for 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyphenol-enriched functional productPolyphenol-enriched functional product | Dietary supplement | Experimental |
| Control without active polyphenolsProduct with identical characteristics to the experimental product, but without active polyphenols. | Dietary supplement | Control |
Primary outcome
Change in Body Weight
Time frame: Day 1 and Day 60
Evaluation of differences in body weight (kg)
Change in fat mass
Time frame: Day 1 and Day 60
Evaluation of differences in fat mass (kg)
Change in fat mass (%)
Time frame: Day 1 and Day 60
Evaluation of differences in fat mass percentage (%)
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).
13 secondary outcomes
Change in fasting glucose
Time frame: Day 1 and Day 60.
Change in fasting insulin
Time frame: Day 1 and Day 60.
Change in plasma leptin levels
Time frame: Day 1 and Day 60
Change in plasma ghrelin levels
Time frame: Day 1 and Day 60
Change in plasma adiponectin levels
Time frame: Day 1 and Day 60
Change in plasma SOCS3 levels
Time frame: Day 1 and Day 60
Change in plasma interleukin-1 (IL-1β) levels
Time frame: Day 1 and Day 60
Change in plasma interleukin-6 (IL-6) levels
Time frame: Day 1 and Day 60
Change in plasma interleukin-10 (IL-10) levels
Time frame: Day 1 and Day 60
Change in plasma oxidized LDL (oxLDL) levels
Time frame: Day 1 and Day 60
Change in plasma malondialdehyde (MDA) levels
Time frame: Day 1 and Day 60
Change in plasma superoxide dismutase (SOD) levels
Time frame: Day 1 and Day 60
Changes in C-reactive protein (CRP)
Time frame: Day 1 and Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Lucas Abellán principal investigator
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol-enriched functional product in people with Obesity and Overweight and Overweight or Obese, run by Carmen Lucas Abellán at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Day 1 and Day 60). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.