Actively Recruiting
Involvement of the Gut Microbiota-brain Cross-talk in the Loss of Eating Control
Led by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Updated on 2026-03-31
116
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Involvement of the Gut Microbiota-brain Cross-talk in the Loss of Eating Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 30-65 years
- Signed informed consent to participate in the study
You will not qualify if you...
- Serious systemic diseases unrelated to obesity such as cancer, severe kidney or liver disease, and type 1 or type 2 diabetes
- Systemic diseases with intrinsic inflammatory activity including rheumatoid arthritis, Crohn's disease, asthma, chronic infections like HIV or tuberculosis, or other infections
- Pregnancy and lactation
- Severe eating behavior disorders
- Legal or administrative restrictions on liberty
- Signs or symptoms of infection in the past month
- Antibiotic, antifungal, or antiviral treatment within the last 3 months
- Chronic treatment with steroidal or non-steroidal anti-inflammatory drugs
- Major psychiatric history
- Excessive alcohol use or drug abuse
- Liver enzyme activity over twice the normal limit
- History of iron balance disorders
- Creatinine over 1.2 or glomerular filtration rate less than 40
- Immunosuppressant treatments
- Chronic constipation with bowel movements every 7 days or more
- Kidney failure, kidney transplant history, or dialysis treatment
- Use of slimming products in the past 2 months
- Severe heart failure (Class III or IV) or ischemic cardiovascular disease
- Current treatment for malignant neoplasm
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institut d'Investigació Biomèdica de Girona (IDIBGI)
Girona, Girona, Spain, 17007
Actively Recruiting
Research Team
J
José Manuel Fernández-Real, M.D., Ph.D.
CONTACT
M
Marisel Rosell Díaz, M.D., MSc.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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