Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis (POINSETTIA)

March 26, 2026 updated by: José Manuel Fernández-Real, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis (POINSETTIA Study)

This study aims to understand how adipose tissue (fat) and the gut microbiota (the bacteria in the gut) may influence brain function and cognition. It has been observed that changes in adipose tissue in animals such as mice and Drosophila (a type of insect) affect memory and other brain functions. Additionally, it is believed that the gut microbiota also plays an important role in cognition.

This study will explore how gene expression in adipose tissue, blood metabolites, and the gut microbiota are related to cognitive function, such as memory and thinking, in individuals with and without obesity. The investigation will also assess whether these factors can predict changes in the brain over time and how they influence sleep, physical activity, and blood sugar regulation.

Advanced technologies will be used to analyze samples of tissue, blood, and microbiota, with the goal of identifying new mechanisms through which obesity affects the brain. This research may contribute to the development of new diagnostic and therapeutic strategies for cognitive problems in individuals with obesity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: José Manuel Fernández-Real, M.D., Ph.D.
  • Phone Number: +34972940200
  • Email: jmfreal@idibgi.org

Study Locations

  • Spain
    • Girona
      • Girona, Girona, Spain, 17007
        • Recruiting
        • Institut d'Investigació Biomèdica de Girona (IDIBGI)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We will make use of the existing samples from the FATBANK cohort (a platform driven by CIBEROBN, managed by the IDIBGI Biobank, and part of the Spanish National Biobank Network). Participants in this cohort had previously signed informed consent to be contacted again. Therefore, the selected participants will be reappointed at the Endocrinology, Diabetes, and Nutrition Service (UDENTG) of the Dr. Josep Trueta Hospital.

Description

Inclusion Criteria:

  • Men and women >20 years old.
  • Scheduled for surgical intervention to extract adipose tissue.
  • Signed informed consent for study participation.

Exclusion Criteria:

  • Not meeting inclusion criteria.
  • Non-obesity-related systemic diseases (cancer, severe kidney/liver disease).
  • Systemic diseases with intrinsic inflammation (rheumatoid arthritis, Crohn's disease, asthma, chronic infections (HIV/tuberculosis)) or any type of infectious disease.
  • Pregnant/breastfeeding women.
  • Persons under legal/administrative restrictions.
  • Those with infection symptoms in the past month.
  • Use of antibiotics/antifungals/antivirals (previous 3 months).
  • Chronic steroidal/anti-inflammatory drug use.
  • Major psychiatric history.
  • Excessive alcohol intake, acute or chronic (>40g/day (women), >80g/day (men)) or drug abuse.
  • Immunosuppressants treatment.
  • Participants with severe eating disorders.
  • Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
  • History of iron balance disorders (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
  • Creatinine greater than 1.2 and glomerular filtration rate below 40.
  • Current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer.
  • Heart disease classified as class III or IV, known ischemic cardiovascular disease.
  • Renal failure, history of kidney transplant, or current dialysis treatment.
  • Chronic constipation (bowel movement frequency ≥ 7 days) .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
OBESITY

With 2 subgroups

  • Man with obesity
  • Women with obesity
WITHOUT OBESITY

With 2 subgroups:

  • Man without obesity
  • Women without obesity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic variability
Time Frame: 36 month
Mean and standard deviation of glucose measures in mg/dL using a CGM 10 days.
36 month
The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl)
Time Frame: 36 months
36 months
The glycaemic risk measured with the low blood glucose index (LBGI)
Time Frame: 36 months
Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic.
36 months
The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)
Time Frame: 36 months
measured in mg/dl
36 months
Minutes light sleep
Time Frame: 36 months
Mean and standard deviation of minutes' light sleep measures by activity and sleep tracker device.
36 months
Minutes deep sleep
Time Frame: 36 months
Mean and standard deviation of minutes' deep sleep measures by activity and sleep tracker device.
36 months
Minutes rapid eye movement (REM)
Time Frame: 36 months
Mean and standard deviation of minutes REM measures by activity and sleep tracker device.
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Audioverbal memory
Time Frame: 36 months
It will be measured by California Verbal Learning Test (CVLT). Minimum/maximum scale values (0-16), where 16 is a better audioverbal memory.
36 months
Effect on gut microbiota
Time Frame: 36 months
Gut microbiota will be analysed by metagenomics and metabolomics.
36 months
Visual memory
Time Frame: 36 months
It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visual memory.
36 months
Depressive symptomatology
Time Frame: 36 months
It will be measured by Patient Health Questionnaire-9 (PHQ-9). Minimum/maximum scale values (0-27), where ≥ 20 is severe depression.
36 months
Impulsivity
Time Frame: 36 months
It will be measured by Impulsive Behaviour Scale (UPPS-P). The test evaluates: Negative urgency (tendency to act rashly under extreme negative emotions), Lack of Premeditation (tendency to act without thinking), Lack of Perseverance (inability to remain focused on a task) and Sensation Seeking (tendency to seek out novel and thrilling experiences). All items are rated on a four point scale from 1 (strongly agree) to 4 (strongly disagree).
36 months
Food Addiction
Time Frame: 36 months
It will be measured by Yale Food Addiction Scale. It is a symptom score from 0-11, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, for substance dependence. Food addiction is diagnosed if ≥3 symptoms are reported.
36 months
Visoconstructive function
Time Frame: 36 months
It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visoconstructive function.
36 months
Selective and alternating attention
Time Frame: 36 months
It will be measured by Trail making test (Part A and B).
36 months
Inhibition
Time Frame: 36 months
It will be measured by Stroop Color-Word Test.
36 months
Phonemic verbal fluency
Time Frame: 36 months
It will be measured by PMR.
36 months
Semantic verbal fluency
Time Frame: 36 months
It will be measured by Animals test. The person must name as many animals as possible in 1 minute. The result is corrected by standard scores, according to age and level of education.
36 months
Facial recognition
Time Frame: 36 months
It will be measured by Picture of Facial Recognition Test (POFA).
36 months
Emotion recognition
Time Frame: 36 months
It will be measured by Benton Facial Recognition Test (BFRT). This test evaluates the recognition of the five basic emotions: happiness, sadness, surprise, disgust, and anger.
36 months
Binge eating disorder
Time Frame: 36 months
It will be measured by Binge Eating Scale (BES). The BES is one of the most widely used measures to assess binge eating disorder symptomatology. The BES score ranges from 0 to 46 and its cut-off point is greater than or equal to 27. Subjects with scores higher than 27 are more likely to suffer from binge eating disorder.
36 months
Anxiety state
Time Frame: 36 months
It will be measured by State-Trate Anxiety Inventory (STAI). This questionnaire evaluates state anxiety (S) and trait anxiety (R) through 20 items each, with a likert-type response scale of four alternatives. In the case of state anxiety, the scale goes from 0 (not at all) to 3 (a lot), while for trait anxiety it goes from 0 (almost never) to 3 (almost always). The higher the score, the greater the anxiety in both concepts.
36 months
Effect on brain structure
Time Frame: 36 months
Brain structure will be assessed using magnetic resonance imaging.
36 months
Diffusion Tensor Imaging brain sequences
Time Frame: 36 months
Diffusion Tensor Imaging was acquired at 1.5 T (Philips ingenia) using a single-shot spin echo sequence with echo-planar imaging (EPI), 50 contiguous slices, voxel size 2x2x2.5 mm3, TE/TR of 72/3581 ms/ms, a diffusion-weighting factor b = 800 s/mm2 and diffusion encoding along 32 directions.
36 months
Brain iron accumulation
Time Frame: 36 months
It will be assessed using magnetic resonance imaging using (R2*)
36 months
Resting-state functional brain sequences
Time Frame: 36 months
It will be assessed using magnetic resonance imaging (T2*-weighted echo-planar imaging). T2 * relaxation data will be acquired with a multi-echo gradient sequence with 10 equidistant echoes (first echo = 4.6ms; echo spacing = 4.6ms; repetition time = 1300ms). The value of T2 * will be calculated by adjusting the simple exponential terms for the signal decay of the respective echo time values.
36 months
Insulin resistance
Time Frame: 36 months
It will be measured by HOMA
36 months
Markers of chronic inflammation (C-reactive protein, IL-6, adiponectin and soluble, tumour necrosis factor-α receptor fractions)
Time Frame: 36 months
Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR)
36 months
Glycosylated haemoglobin (HbA1c) value
Time Frame: 36 months
Glycosylated haemoglobin (HbA1c) in % or mmol/mol
36 months
The percentage of time in hyperglycaemia (glucose level above 250 mg/dl)
Time Frame: 36 months
36 months
The percentage of time in hypoglycaemia (glucose level below 70mg/dl)
Time Frame: 36 months
36 months
The percentage of time in glucose range (glucose level below 100 mg/dl)
Time Frame: 36 months
36 months
The percentage of time in glucose range (glucose level between 126-139 mg/dl)
Time Frame: 36 months
36 months
The percentage of time in glucose range (glucose level between 140-199 mg/dl)
Time Frame: 36 months
36 months
The percentage of time in glucose range (glucose level above 200 mg/dl)
Time Frame: 36 months
36 months
Burned calories
Time Frame: 36 months
Mean and standard deviation of burned calories measures by activity and sleep tracker device.
36 months
Steps Mean and standard deviation of steps measures by activity and sleep tracker device.
Time Frame: 36 months
The mean and standard deviation of steps refer to the average number of steps taken by a participant and how much those steps vary from the average, as measured by an activity and sleep tracker device. The mean is the average, while the standard deviation shows the variation or consistency in step count.
36 months
Distance Mean and standard deviation of distance measures by activity and sleep tracker device.
Time Frame: 36 months
36 months
Minutes null activity
Time Frame: 36 months
Mean and standard deviation of minutes' null activity measures by activity and sleep
36 months
Minutes slight activity
Time Frame: 36 months
Mean and standard deviation of minutes slight activity measures by activity and sleep
36 months
Minutes mean activity
Time Frame: 36 months
Mean and standard deviation of minutes mean activity measures by activity and sleep tracker device.
36 months
Minutes high activity
Time Frame: 36 months
Mean and standard deviation of minutes high activity measures by activity and sleep tracker device.
36 months
Calories
Time Frame: 36 months
Mean and standard deviation of calories measures by activity and sleep tracker device.
36 months
Minutes asleep
Time Frame: 36 months
Mean and standard deviation of minutes asleep measures by activity and sleep tracker.
36 months
Minutes awake
Time Frame: 36 months
Mean and standard deviation of minutes awake measures by activity and sleep tracker.
36 months
Bed time Mean and standard deviation of bed time measures by activity and sleep tracker device.
Time Frame: 36 months
36 months
Number time awake Mean and standard deviation of number time awake measures by activity and sleep
Time Frame: 36 months
36 months
Behavioural inhibition
Time Frame: 36 months
It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The scale of Sensitivity to Punishment is related to the behavioural inhibition system. It is made up of two subscales of 24 items each. For each subscale, the minimum score is 0 and the maximum score is 24, with higher scores indicating greater sensitivity to punishment or reward, respectively.
36 months
Behavioural activation
Time Frame: 36 months
It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The reward sensitivity scale is related to the behavioural activation system. The questionnaire consists of two subscales of 24 items each. Each subscale ranges from 0 (minimum) to 24 (maximum), where a higher score indicates greater sensitivity to reward or punishment, respectively.
36 months
Attention and working memory
Time Frame: 36 months
It will be measured by the Digits subtest of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). This subtest includes two parts: Digits Forward (measuring attention) and Digits Backward (measuring working memory). The total raw score ranges from 0 (minimum) to 30 (maximum), with higher scores indicating better attention and working memory capacity.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: José Manuel Fernández-Real, M.D., Ph.D., Institut d'Investigacio Biomedica de Girona Dr. Josep Trueta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POINSETTIA-2024.200

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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