Food Intake-Related Brain and Metabolic Responses in Obesity
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study is a prospective, single-center, randomized, controlled, crossover intervention trial. A total of 60 participants, including 30 patients with obesity and 30 healthy controls, will be enrolled. Each participant will receive an isocaloric liquid meal challenge (glucose, fat, or protein) on three separate experimental days, with a washout period of at least 7 days between visits to eliminate carryover effects from the previous intervention. The primary objective is to investigate the association between brain functional patterns and plasma metabolic profiles following the ingestion of different macronutrients in patients with obesity, aiming to uncover potential neuro-metabolic imbalance features.
Eligibility Criteria
Inclusion Criteria: Obese participants: 1. BMI ≥ 28 kg/m²; 2. Age 18-40 years; 3. Any gender; 4. Right-handed. Healthy control participants: 1. BMI 18.5-23.9 kg/m²; 2. Age 18-40 years; 3. Any gender; 4. Right-handed. Exclusion Criteria: 1. Diabetes mellitus; 2. Contraindications or allergies to any ingredient in the standardized meal or macronutrient challenges used in this study; 3. Central nervous system disorders (e.g., traumatic brain injury, acute cerebral infarction, epilepsy) or psychiatric disorders (e.g., depression, schizophrenia); use of medications acting on the central nervous system within the past 3 months or long-term use; 4. Severe impairment of liver, kidney, heart, or gastrointestinal function, including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2 times the upper limit of normal; estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m² calculated by the CKD-EPI equation; history of unstable angina or myocardial infarction