Brain and metabolic responses to different macronutrients in people with obesity
Association Between Food Intake-Related Brain Functional Patterns and Metabolic Profiles in Patients With Obesity: A Randomized Crossover Trial
This trial will test whether three small, isocaloric liquid meals (glucose, fat, or protein) change brain activity and blood metabolites in adults with obesity and healthy-weight adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07392905 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, randomized, controlled crossover trial enrolling 60 adults (30 with obesity and 30 healthy-weight controls). Each participant will receive three isocaloric (200 kcal), isovolumetric (300 mL) liquid challenges—glucose, fat (intralipid), and whey protein—on separate days in random order with at least a 7-day washout between visits. Brain function will be measured by fMRI and plasma samples collected for metabolomic profiling before and after each nutrient challenge to link neural responses with metabolic changes. The study aims to identify neuro-metabolic patterns associated with macronutrient responses in obesity compared with healthy controls.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults aged 18–40 who either have obesity (BMI ≥28 kg/m²) or are healthy-weight controls (BMI 18.5–23.9 kg/m²), are free of diabetes and major organ, neurological, or psychiatric conditions, and can undergo fMRI.
Not a fit: People with diabetes, significant liver/kidney/heart disease, uncontrolled psychiatric or neurological disorders, inability to undergo MRI, allergies to study meal ingredients, or those outside the age or BMI ranges are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the findings could help tailor dietary or therapeutic strategies by revealing how different macronutrients drive brain and metabolic responses in obesity.
How similar studies have performed: Previous studies have shown that macronutrients can alter brain activity and blood metabolite profiles, but combining randomized crossover macronutrient challenges with detailed plasma metabolomics and fMRI in obesity remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Yan Bi — Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
- Study coordinator: Yan Bi
- Email: biyan@nju.edu.cn
- Phone: 6-25-83-105302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.