Institut d'Investigació Biomèdica de Girona (IDIBGI)
Girona, 17007, Spain
Location status: Recruiting
NCT Number: NCT06869941
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.
Interested in participating?
Request Info20 year and older
All sexes
Observational
Girona, 17007, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 36 month
Mean and standard deviation of glucose measures in mg/dL using a CGM 10 days.
Time frame: 36 months
Time frame: 36 months
Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic.
Time frame: 36 months
measured in mg/dl
Time frame: 36 months
Mean and standard deviation of minutes' light sleep measures by activity and sleep tracker device.
Time frame: 36 months
Mean and standard deviation of minutes' deep sleep measures by activity and sleep tracker device.
Time frame: 36 months
Mean and standard deviation of minutes REM measures by activity and sleep tracker device.
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.
Time frame: 36 months
Gut microbiota will be analysed by metagenomics and metabolomics.
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.
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.
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).
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.
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.
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.
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.
Time frame: 36 months
It will be measured by Trail making test (Part A and B).
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.
Time frame: 36 months
It will be measured by Stroop Color-Word Test.
Time frame: 36 months
It will be measured by PMR.
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.
Time frame: 36 months
It will be measured by Picture of Facial Recognition Test (POFA).
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.
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.
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.
Time frame: 36 months
Brain structure will be assessed using magnetic resonance imaging.
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.
Time frame: 36 months
It will be assessed using magnetic resonance imaging using (R2*)
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.
Time frame: 36 months
It will be measured by HOMA
Time frame: 36 months
Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR)
Time frame: 36 months
Glycosylated haemoglobin (HbA1c) in % or mmol/mol
Time frame: 36 months
Time frame: 36 months
Time frame: 36 months
Time frame: 36 months
Time frame: 36 months
Time frame: 36 months
Time frame: 36 months
Mean and standard deviation of burned calories 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.
Time frame: 36 months
Time frame: 36 months
Mean and standard deviation of minutes' null activity measures by activity and sleep
Time frame: 36 months
Mean and standard deviation of minutes slight activity measures by activity and sleep
Time frame: 36 months
Mean and standard deviation of minutes mean activity measures by activity and sleep tracker device.
Time frame: 36 months
Mean and standard deviation of minutes high activity measures by activity and sleep tracker device.
Time frame: 36 months
Mean and standard deviation of calories measures by activity and sleep tracker device.
Time frame: 36 months
Mean and standard deviation of minutes asleep measures by activity and sleep tracker.
Time frame: 36 months
Mean and standard deviation of minutes awake measures by activity and sleep tracker.
Time frame: 36 months
Time frame: 36 months
Contact information is provided by the study sponsor or research team.
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Other
Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis (POINSETTIA Study)
Acronym: POINSETTIA
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.
Published trials that share one or more normalized conditions with this study.
NCT06619041
Behavior, Body Weight
Aurora, Colorado, United States
View Trial DetailsNCT06858761
Body Weight, Nutrition Disorders
Bordeaux, France
View Trial DetailsNCT06374875
Body Weight, Digestive System Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT06325722
Body Weight, Body Weight Changes
Bethesda, Maryland, United States
View Trial Details