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NCT Number: NCT06869941

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut d'Investigació Biomèdica de Girona (IDIBGI)

Girona, 17007, Spain

Location status: Recruiting

Location contact

Yenny Leal

CONTACT

[email protected]

0034 972940200 ext. 2325

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) .

Treatment and study plan

Primary outcomes

  1. Glycemic variability

    Time frame: 36 month

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

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

    Time frame: 36 months

  3. 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.

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

    Time frame: 36 months

    measured in mg/dl

  5. Minutes light sleep

    Time frame: 36 months

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

  6. Minutes deep sleep

    Time frame: 36 months

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

  7. Minutes rapid eye movement (REM)

    Time frame: 36 months

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

Secondary outcomes

  1. 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.

  2. Effect on gut microbiota

    Time frame: 36 months

    Gut microbiota will be analysed by metagenomics and metabolomics.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Selective and alternating attention

    Time frame: 36 months

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

  11. 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.

  12. Inhibition

    Time frame: 36 months

    It will be measured by Stroop Color-Word Test.

  13. Phonemic verbal fluency

    Time frame: 36 months

    It will be measured by PMR.

  14. 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.

  15. Facial recognition

    Time frame: 36 months

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

  16. 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.

  17. 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.

  18. 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.

  19. Effect on brain structure

    Time frame: 36 months

    Brain structure will be assessed using magnetic resonance imaging.

  20. 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.

  21. Brain iron accumulation

    Time frame: 36 months

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

  22. 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.

  23. Insulin resistance

    Time frame: 36 months

    It will be measured by HOMA

  24. 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)

  25. Glycosylated haemoglobin (HbA1c) value

    Time frame: 36 months

    Glycosylated haemoglobin (HbA1c) in % or mmol/mol

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

    Time frame: 36 months

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

    Time frame: 36 months

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

    Time frame: 36 months

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

    Time frame: 36 months

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

    Time frame: 36 months

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

    Time frame: 36 months

  32. Burned calories

    Time frame: 36 months

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

  33. 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.

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

    Time frame: 36 months

  35. Minutes null activity

    Time frame: 36 months

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

  36. Minutes slight activity

    Time frame: 36 months

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

  37. Minutes mean activity

    Time frame: 36 months

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

  38. Minutes high activity

    Time frame: 36 months

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

  39. Calories

    Time frame: 36 months

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

  40. Minutes asleep

    Time frame: 36 months

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

  41. Minutes awake

    Time frame: 36 months

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

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

    Time frame: 36 months

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

    Time frame: 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+34972940200

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study title

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

Acronym: POINSETTIA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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