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ObesityPOINSETTIANCT06869941

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

An observational study of Obesity, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Obesity
How many people
100 participants
Where
1 siteSpain
Study dates
5 Aug 2025to 31 Jan 2027
How long will I take part?
1 Month
Phase
Observational
Are there results?
Not yet: the study is under way

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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) .

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

José Manuel Fernández-Real, M.D., Ph.D. contact

+34972940200

jmfreal@idibgi.org

Spain1 site, 1 recruiting

  • Institut d'Investigació Biomèdica de Girona (IDIBGI)

    Girona, Girona, 17007

    Yenny Leal, 0034 972940200 ext. 2325, yleal@idibgi.org

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Conditions
Obesity
Keywords
Continous Glucose Monitoring, Cognition, Gut-microbiota-brain axis
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06869941
Study groupRoleWhat they receive
OBESITYWith 2 subgroups * Man with obesity * Women with obesity
WITHOUT OBESITYWith 2 subgroups: * Man without obesity * Women without obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic variability

    Mean and standard deviation of glucose measures in mg/dL using a CGM 10 days.

    Measured: 36 month

  2. The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl)

    Measured: 36 months

  3. The glycaemic risk measured with the low blood glucose index (LBGI)

    Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic.

    Measured: 36 months

  4. The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)

    measured in mg/dl

    Measured: 36 months

  5. Minutes light sleep

    Mean and standard deviation of minutes' light sleep measures by activity and sleep tracker device.

    Measured: 36 months

  6. Minutes deep sleep

    Mean and standard deviation of minutes' deep sleep measures by activity and sleep tracker device.

    Measured: 36 months

  7. Minutes rapid eye movement (REM)

    Mean and standard deviation of minutes REM measures by activity and sleep tracker device.

    Measured: 36 months

Secondary outcomes (43)

  1. Audioverbal memory

    It will be measured by California Verbal Learning Test (CVLT). Minimum/maximum scale values (0-16), where 16 is a better audioverbal memory.

    Measured: 36 months

  2. Effect on gut microbiota

    Gut microbiota will be analysed by metagenomics and metabolomics.

    Measured: 36 months

  3. Visual memory

    It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visual memory.

    Measured: 36 months

  4. Depressive symptomatology

    It will be measured by Patient Health Questionnaire-9 (PHQ-9). Minimum/maximum scale values (0-27), where ≥ 20 is severe depression.

    Measured: 36 months

  5. Impulsivity

    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).

    Measured: 36 months

  6. Food Addiction

    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.

    Measured: 36 months

  7. Behavioural inhibition

    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.

    Measured: 36 months

  8. Behavioural activation

    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.

    Measured: 36 months

  9. Visoconstructive function

    It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visoconstructive function.

    Measured: 36 months

  10. Selective and alternating attention

    It will be measured by Trail making test (Part A and B).

    Measured: 36 months

  11. Attention and working memory

    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.

    Measured: 36 months

  12. Inhibition

    It will be measured by Stroop Color-Word Test.

    Measured: 36 months

  13. Phonemic verbal fluency

    It will be measured by PMR.

    Measured: 36 months

  14. Semantic verbal fluency

    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.

    Measured: 36 months

  15. Facial recognition

    It will be measured by Picture of Facial Recognition Test (POFA).

    Measured: 36 months

  16. Emotion recognition

    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.

    Measured: 36 months

  17. Binge eating disorder

    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.

    Measured: 36 months

  18. Anxiety state

    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.

    Measured: 36 months

  19. Effect on brain structure

    Brain structure will be assessed using magnetic resonance imaging.

    Measured: 36 months

  20. Diffusion Tensor Imaging brain sequences

    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.

    Measured: 36 months

  21. Brain iron accumulation

    It will be assessed using magnetic resonance imaging using (R2*)

    Measured: 36 months

  22. Resting-state functional brain sequences

    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.

    Measured: 36 months

  23. Insulin resistance

    It will be measured by HOMA

    Measured: 36 months

  24. Markers of chronic inflammation (C-reactive protein, IL-6, adiponectin and soluble, tumour necrosis factor-α receptor fractions)

    Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR)

    Measured: 36 months

  25. Glycosylated haemoglobin (HbA1c) value

    Glycosylated haemoglobin (HbA1c) in % or mmol/mol

    Measured: 36 months

  26. The percentage of time in hyperglycaemia (glucose level above 250 mg/dl)

    Measured: 36 months

  27. The percentage of time in hypoglycaemia (glucose level below 70mg/dl)

    Measured: 36 months

  28. The percentage of time in glucose range (glucose level below 100 mg/dl)

    Measured: 36 months

  29. The percentage of time in glucose range (glucose level between 126-139 mg/dl)

    Measured: 36 months

  30. The percentage of time in glucose range (glucose level between 140-199 mg/dl)

    Measured: 36 months

  31. The percentage of time in glucose range (glucose level above 200 mg/dl)

    Measured: 36 months

  32. Burned calories

    Mean and standard deviation of burned calories measures by activity and sleep tracker device.

    Measured: 36 months

  33. Steps Mean and standard deviation of steps measures by activity and sleep tracker device.

    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.

    Measured: 36 months

  34. Distance Mean and standard deviation of distance measures by activity and sleep tracker device.

    Measured: 36 months

  35. Minutes null activity

    Mean and standard deviation of minutes' null activity measures by activity and sleep

    Measured: 36 months

  36. Minutes slight activity

    Mean and standard deviation of minutes slight activity measures by activity and sleep

    Measured: 36 months

  37. Minutes mean activity

    Mean and standard deviation of minutes mean activity measures by activity and sleep tracker device.

    Measured: 36 months

  38. Minutes high activity

    Mean and standard deviation of minutes high activity measures by activity and sleep tracker device.

    Measured: 36 months

  39. Calories

    Mean and standard deviation of calories measures by activity and sleep tracker device.

    Measured: 36 months

  40. Minutes asleep

    Mean and standard deviation of minutes asleep measures by activity and sleep tracker.

    Measured: 36 months

  41. Minutes awake

    Mean and standard deviation of minutes awake measures by activity and sleep tracker.

    Measured: 36 months

  42. Bed time Mean and standard deviation of bed time measures by activity and sleep tracker device.

    Measured: 36 months

  43. Number time awake Mean and standard deviation of number time awake measures by activity and sleep

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start5 Aug 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT06869941
Sponsor's protocol ID
POINSETTIA-2024.200
Acronym
POINSETTIA
Status last verified
Mar 2026
First submitted
5 Mar 2025
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mayneris-Perxachs J, Arnoriaga-Rodriguez M, Garre-Olmo J, Puig J, Ramos R, Trelis M, Burokas A, Coll C, Zapata-Tona C, Pedraza S, Perez-Brocal V, Ramio L, Ricart W, Moya A, Jove M, Sol J, Portero-Otin M, Pamplona R, Maldonado R, Fernandez-Real JM. Presence of Blastocystis in gut microbiota is associated with cognitive traits and decreased executive function. ISME J. 2022 Sep;16(9):2181-2197. doi: 10.1038/s41396-022-01262-3. Epub 2022 Jun 21.

    PubMed 35729225

  • Bier E. Drosophila, the golden bug, emerges as a tool for human genetics. Nat Rev Genet. 2005 Jan;6(1):9-23. doi: 10.1038/nrg1503.

    PubMed 15630418

  • Douglas AE. The Drosophila model for microbiome research. Lab Anim (NY). 2018 Jun;47(6):157-164. doi: 10.1038/s41684-018-0065-0. Epub 2018 May 23.

    PubMed 29795158

  • Quesada-Vazquez S, Castells-Nobau A, Latorre J, Oliveras-Canellas N, Puig-Parnau I, Tejera N, Tobajas Y, Baudin J, Hildebrand F, Beraza N, Burcelin R, Martinez-Gili L, Chilloux J, Dumas ME, Federici M, Hoyles L, Caimari A, Del Bas JM, Escote X, Fernandez-Real JM, Mayneris-Perxachs J. Potential therapeutic implications of histidine catabolism by the gut microbiota in NAFLD patients with morbid obesity. Cell Rep Med. 2023 Dec 19;4(12):101341. doi: 10.1016/j.xcrm.2023.101341.

    PubMed 38118419

  • Mayneris-Perxachs J, Moreno-Navarrete JM, Ballanti M, Monteleone G, Alessandro Paoluzi O, Mingrone G, Lefebvre P, Staels B, Federici M, Puig J, Garre J, Ramos R, Fernandez-Real JM. Lipidomics and metabolomics signatures of SARS-CoV-2 mediators/receptors in peripheral leukocytes, jejunum and colon. Comput Struct Biotechnol J. 2021;19:6080-6089. doi: 10.1016/j.csbj.2021.11.007. Epub 2021 Nov 8.

    PubMed 34777716

  • Lin H, Peddada SD. Analysis of compositions of microbiomes with bias correction. Nat Commun. 2020 Jul 14;11(1):3514. doi: 10.1038/s41467-020-17041-7.

    PubMed 32665548

  • Albanese D, Donati C. Strain profiling and epidemiology of bacterial species from metagenomic sequencing. Nat Commun. 2017 Dec 22;8(1):2260. doi: 10.1038/s41467-017-02209-5.

    PubMed 29273717

  • Zhao S, Li H, Han W, Chan W, Li L. Metabolomic Coverage of Chemical-Group-Submetabolome Analysis: Group Classification and Four-Channel Chemical Isotope Labeling LC-MS. Anal Chem. 2019 Sep 17;91(18):12108-12115. doi: 10.1021/acs.analchem.9b03431. Epub 2019 Sep 5.

    PubMed 31441644

  • Arnoriaga-Rodriguez M, Mayneris-Perxachs J, Burokas A, Contreras-Rodriguez O, Blasco G, Coll C, Biarnes C, Miranda-Olivos R, Latorre J, Moreno-Navarrete JM, Castells-Nobau A, Sabater M, Palomo-Buitrago ME, Puig J, Pedraza S, Gich J, Perez-Brocal V, Ricart W, Moya A, Fernandez-Real X, Ramio-Torrenta L, Pamplona R, Sol J, Jove M, Portero-Otin M, Maldonado R, Fernandez-Real JM. Obesity Impairs Short-Term and Working Memory through Gut Microbial Metabolism of Aromatic Amino Acids. Cell Metab. 2020 Oct 6;32(4):548-560.e7. doi: 10.1016/j.cmet.2020.09.002.

    PubMed 33027674

  • Mayneris-Perxachs J, Castells-Nobau A, Arnoriaga-Rodriguez M, Garre-Olmo J, Puig J, Ramos R, Martinez-Hernandez F, Burokas A, Coll C, Moreno-Navarrete JM, Zapata-Tona C, Pedraza S, Perez-Brocal V, Ramio-Torrenta L, Ricart W, Moya A, Martinez-Garcia M, Maldonado R, Fernandez-Real JM. Caudovirales bacteriophages are associated with improved executive function and memory in flies, mice, and humans. Cell Host Microbe. 2022 Mar 9;30(3):340-356.e8. doi: 10.1016/j.chom.2022.01.013. Epub 2022 Feb 16.

    PubMed 35176247

  • Mayneris-Perxachs J, Castells-Nobau A, Arnoriaga-Rodriguez M, Martin M, de la Vega-Correa L, Zapata C, Burokas A, Blasco G, Coll C, Escrichs A, Biarnes C, Moreno-Navarrete JM, Puig J, Garre-Olmo J, Ramos R, Pedraza S, Brugada R, Vilanova JC, Serena J, Gich J, Ramio-Torrenta L, Perez-Brocal V, Moya A, Pamplona R, Sol J, Jove M, Ricart W, Portero-Otin M, Deco G, Maldonado R, Fernandez-Real JM. Microbiota alterations in proline metabolism impact depression. Cell Metab. 2022 May 3;34(5):681-701.e10. doi: 10.1016/j.cmet.2022.04.001.

    PubMed 35508109

  • Oliveras-Canellas N, Castells-Nobau A, de la Vega-Correa L, Latorre-Luque J, Motger-Alberti A, Arnoriaga-Rodriguez M, Garre-Olmo J, Zapata-Tona C, Coll-Martinez C, Ramio-Torrenta L, Moreno-Navarrete JM, Puig J, Villarroya F, Ramos R, Casado-Anguera V, Martin-Garcia E, Maldonado R, Mayneris-Perxachs J, Fernandez-Real JM. Adipose tissue coregulates cognitive function. Sci Adv. 2023 Aug 11;9(32):eadg4017. doi: 10.1126/sciadv.adg4017. Epub 2023 Aug 11.

    PubMed 37566655

  • Xia D, Kelleher RJ 3rd, Shen J. Loss of Abeta43 Production Caused by Presenilin-1 Mutations in the Knockin Mouse Brain. Neuron. 2016 Apr 20;90(2):417-22. doi: 10.1016/j.neuron.2016.03.009.

    PubMed 27100200

  • Wechsler, D. WAIS IV: Escala de Inteligencia de Wechsler para Adultos-IV. Madrid: TEA. 2012

  • Guo DH, Yamamoto M, Hernandez CM, Khodadadi H, Baban B, Stranahan AM. Beige adipocytes mediate the neuroprotective and anti-inflammatory effects of subcutaneous fat in obese mice. Nat Commun. 2021 Jul 30;12(1):4623. doi: 10.1038/s41467-021-24540-8.

    PubMed 34330904

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta 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 3 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 31 Mar 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact José Manuel Fernández-Real, M.D., Ph.D. (+34972940200, jmfreal@idibgi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic variability (time frame: 36 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06869941, which also lists 32 linked publications.

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 31 Mar 2026.

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