Food Intake-Related Brain and Metabolic Responses in Obesity (NCT07392905) | Clinical Trial Compass
RecruitingNot Applicable
Food Intake-Related Brain and Metabolic Responses in Obesity
China60 participantsStarted 2025-12-21
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. BMI ≥ 28 kg/m²;
✓. Age 18-40 years;
✓. Any gender;
✓. Right-handed.
✓. 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;
What they're measuring
1
Acute Brain Functional Response to Macronutrient Challenges
Timeframe: Baseline (pre-challenge) and within 0-20 minutes post-challenge on each experimental day
2
Dynamic Plasma Metabolomic Response to Macronutrient Challenges
Timeframe: Baseline (pre-challenge), 30 minutes post-challenge, and 120 minutes post-challenge on each experimental day.
Trial details
NCT IDNCT07392905
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
✕. 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;