NCT07392905 Food Intake-Related Brain and Metabolic Responses in Obesity
| NCT ID | NCT07392905 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-21 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-12-21 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Yan Bi
PRINCIPAL INVESTIGATOR
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Frequently Asked Questions
Who can join the NCT07392905 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07392905 currently recruiting?
Yes, NCT07392905 is actively recruiting participants. Contact the research team at biyan@nju.edu.cn for enrollment information.
Where is the NCT07392905 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07392905 clinical trial?
NCT07392905 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Yan Bi at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University. The trial plans to enroll 60 participants.
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