Involvement of the Gut Microbiota-brain Cross-talk in the Loss of Eating Control

Condition(s) studied

Study summary

Overweight and obesity are increasingly prevalent worldwide. These bodyweight disorders are closely related to deficiencies in the control of food intake. A potential yet unexplored mechanism to explain the loss of eating control is the interaction between the gut microbiota and the brain. The mechanisms underlying the communication between the gut microbiome and the host remain largely unexplored. These mechanisms could occur in part through small non-coding RNAs, called microRNAs (miRNAs). miRNAs regulate epigenetic mechanisms to control gene expression.

Two hypotheses have been proposed:

I. The interaction between the gut microbiota and the brain and its associated epigenetic changes play an important role in the overweight-related loss of eating control and metabolic imbalance.

II.The composition and functionality of the gut microbiota are associated with circulating microRNAs and glycemic variability and modify the effect of physical activity on cognitive parameters and brain microstructure (R2\*).

The study includes a cross-sectional design (comparison of subjects with and without obesity) to evaluate parameters associated with food addiction through validated questionnaires. The metabolic and behavioral profiles of the cohort will be characterized. The medial prefrontal cortex connectivity will be studied using functional magnetic resonance imaging (fMRI). The composition and functionality of the gut metagenome of the subjects will be analyzed in association with metabolic and behavioral parameters and imaging data. miRNAs can act as mediators of epigenomics of the effects of the metagenome that impact the brain, therefore it will be analyzed a broad profile of miRNAs circulating in plasma.

Eligibility

Primary outcome measure(s)

• Concentration of advanced glycation end products (AGE) receptor agonists. — 10 days
  Enzyme-linked immunosorbent assay (ELISA).
• Glycemic variability. — 10 days
  Mean and standard deviation of glucose measures in mg/dL using a continuous glucose monitoring during 10 days.
• The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl) — 10 days
• The glycaemic risk measured with low blood glucose index (LBGI) — 10 days
  Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic
• The glycaemic risk measured with high blood glucose index (HBGI). — 10 days
  High blood glucose index (HBGI) is a parameter that quantifies the risk of glycaemic.
• The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE). — 10 days
  measured in mg/dl
• Minutes light sleep — 10 days
  Mean and standard deviation of minutes light sleep measures by activity and sleep tracker device.
• Minutes deep sleep — 10 days
  Mean and standard deviation of minutes deep sleep measures by activity and sleep
• Minutes rapid eye movement (REM) — 10 days
  Mean and standard deviation of minutes REM measures by activity and sleep tracker device.
• Effect on gut microbiota. — 2 months
  Gut microbiota will be analysed by metagenomics and metabolomics.
• Visual memory — 10 days
  It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visual memory.
• Audioverbal memory — 10 days
  It will be measured by California Verbal Learning Test (CVLT). Minimum/maximum scale values (0-16), where 16 is a better audioverbal memory.
• Depressive symptomatology — 10 days
  It will be measured by Patient Health Questionnaire-9 (PHQ-9). Minimum/maximum scale values (0-27), where ≥ 20 is severe depression.
• Impulsivity — 10 days
  It will be measured by Impulsive Behavior 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).
• Food Addiction — 10 days
  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.
• Behavioral inhibition — 10 days
  It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The scale of sensitivity to punishment is related to the behavioral inhibition system. It is made up of two subscales of 24 items each, where the higher the score, the greater the sensitivity to punishment.
• Behavioral activation — 10 days
  It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The reward sensitivity scale is related to the behavioral activation system. It is made up of two subscales of 24 items each, where the higher the score, the greater the sensitivity to reward.
• Visoconstructive function — 10 days
  It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visoconstructive function.
• Selective and alternating attention — 10 days
  It will be measured by Trail making test (Part A y B).
• Attention and working memory — 10 days
  It will be measured by the Digits subtest of Wechsler Adult Intelligence Scales, Fourth Edition (WAIS-IV).
• Inhibition — 10 days
  It will be measured by Stroop Color-Word Test.
• Phonemic verbal fluency — 10 days
  It will be measured by PMR
• Semantic verbal fluency — 10 days
  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.
• Binge eating disorder — 10 days
  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.
• Anxiety — 10 days
  It will be measured by State-Trait 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.
• Facial recognition — 10 days
  It will be measured by Benton Facial Recognition Test. The participant is shown a face and then must recognize it among six faces placed together.
• Emotion recognition — 10 days
  It will be measured by Pictures of Facial Affect. The participant will be shown pictures of people and has to recognize what emotion the subjects of the pictures are expressing ( happiness, sadness, etc.).

Trial sites (1)

More Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta trials in Spain

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