Recruiting nowNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 40 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Brain Function, Metabolomics, Feeding Behavior, Macronutrients
Full registry 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 within the past 3 months, or heart failure classified as New York Heart Association (NYHA) class II or higher; history of gastrointestinal stoma, bowel resection, intestinal obstruction, or peptic ulcer disease; 5. Contraindications to MRI, such as implanted metallic devices or claustrophobia; 6. Pregnancy or lactation; 7. Participation in another clinical trial currently or within the past 3 months; use of nutritional supplements within the past 3 months or long-term use; 8. History of prior metabolic/bariatric surgery; 9. Use of antibiotics or probiotics within the past 1 month; 10. Use of medications affecting metabolism or causing weight loss within the past 1 month; body weight fluctuation exceeding 3 kg during the month prior to screening; 11. Unusual dietary habits; daily alcohol intake \>40 grams, smoking \>10 cigarettes per day, or coffee consumption ≥2 cups per day.
Treatments and study arms
Glucose Liquid Meal
Dietary Supplement
A standardized, isocaloric (200 kcal), isovolumetric (300 mL) liquid meal containing 50 g pure glucose. Administered orally 6 hours after a standardized pre-load meal.
Fat Liquid Meal
Dietary Supplement
A standardized, isocaloric (200 kcal), isovolumetric (300 mL) liquid meal prepared from 100 mL of intralipid emulsion diluted with water. Administered orally 6 hours after a standardized pre-load meal.
Protein Liquid Meal
Dietary Supplement
A standardized, isocaloric (200 kcal), isovolumetric (300 mL) liquid meal containing 54 g whey protein isolate powder. Administered orally 6 hours after a standardized pre-load meal.
Primary outcomes
Acute Brain Functional Response to Macronutrient ChallengesBaseline (pre-challenge) and within 0-20 minutes post-challenge on each experimental dayChanges in whole-brain functional activation patterns assessed by blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI), comparing pre-challenge baseline with post-challenge scans acquired within 20 minutes after ingestion of glucose, fat, or protein.
Dynamic Plasma Metabolomic Response to Macronutrient ChallengesBaseline (pre-challenge), 30 minutes post-challenge, and 120 minutes post-challenge on each experimental day.Temporal changes in plasma metabolic profiles characterized by untargeted metabolomic profiling, evaluating the evolution of metabolite concentrations across three time points: before intervention, 30 minutes post-intervention, and 120 minutes post-intervention, following single-dose challenges with glucose, fat, or protein.
