Food Intake-Related Brain and Metabolic Responses in Obesity
Recruiting · NCT07392905 · Interventional (participants receive a specific treatment) · Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Inclusion criteria
- bese participants:
- BMI ≥ 28 kg/m²;
- Age 18-40 years;
- Any gender;
- Right-handed.
- Healthy control participants:
- BMI 18.5-23.9 kg/m²;
- Age 18-40 years;
- Any gender;
- Right-handed.
Exclusion criteria
- Diabetes mellitus;
- Contraindications or allergies to any ingredient in the standardized meal or macronutrient challenges used in this study;
- 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;
- 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;
- Contraindications to MRI, such as implanted metallic devices or claustrophobia;
- Pregnancy or lactation;
- 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;
- History of prior metabolic/bariatric surgery;
- Use of antibiotics or probiotics within the past 1 month;
- 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;
- Unusual dietary habits; daily alcohol intake \>40 grams, smoking \>10 cigarettes per day, or coffee consumption ≥2 cups per day.
Where it is running
1 location listed.
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University - Nanjing, Jiangsu, China