Brain and metabolic responses to different macronutrients in people with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.