Actively Recruiting
Association Between Food Intake-Related Brain Functional Patterns and Metabolic Profiles in Patients With Obesity: A Randomized Crossover Trial
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2026-02-06
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how different macronutrients affect brain activity and metabolism in people with obesity compared to healthy individuals. This study enrolls 60 adults aged 18 to 40 years, including 30 with obesity and 30 healthy controls. It is a randomized, controlled, crossover trial designed to understand possible neuro-metabolic imbalances related to food intake in obesity. Participants receive three different liquid meal challenges containing glucose, fat, or protein on separate days, with at least a 7-day break between visits to prevent overlap effects. Each meal is standardized to provide 200 kcal and 300 mL volume and is given 6 hours after a standardized pre-load meal. The order of nutrient challenges is randomized across participants to balance treatment sequences. During each visit, participants fast beforehand and undergo clinical tests, body composition analysis, liver fat measurement, and eating behavior questionnaires. They provide blood and stool samples at multiple times after the meal and have brain scans using fMRI to assess brain function related to the nutrient intake. Researchers measure brain responses, blood metabolic profiles, and feelings of fullness to explore the connection between brain activity and metabolism in response to different nutrients. The study includes careful monitoring and detailed data collection over the three experimental days.
CONDITIONS
Brief Title
Food Intake-Related Brain and Metabolic Responses in Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Obese participants must have a body mass index (BMI) of 28 kg/m2 or higher
- Healthy control participants must have a BMI between 18.5 and 23.9 kg/m2
- Participants must be aged between 18 and 40 years
- Participants can be of any gender
- Participants must be right-handed
You will not qualify if you...
- Diagnosis of diabetes mellitus
- Allergies or contraindications to ingredients in the standardized meal or macronutrient challenges
- Central nervous system disorders or psychiatric disorders, or use of related medications within the past 3 months
- Severe liver, kidney, heart, or gastrointestinal problems
- Contraindications to MRI, like metallic implants or claustrophobia
- Pregnancy or breastfeeding
- Participation in another clinical trial or use of nutritional supplements within the past 3 months
- History of metabolic or bariatric surgery
- Use of antibiotics, probiotics, or metabolism-affecting medications within the past month
- Body weight changes over 3 kg in the month before screening
- Unusual dietary habits or excessive alcohol, smoking, or coffee intake
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - At least 3 experimental days separated by minimum 7-day washout periods
Participants undergo three separate experimental days receiving different macronutrient liquid meals (glucose, fat, protein) in a randomized order. Each day includes fasting, clinical tests, body composition assessment, hepatic fat quantification, questionnaires, postprandial satiety ratings, blood and stool sample collections, and brain imaging (fMRI). There is a washout period of at least 7 days between each intervention day.
3 visits (in-person), one for each macronutrient challenge, with at least 7 days between visits
Trial Site Locations
Total: 1 location
1
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China, China 210008
Actively Recruiting
Research Team
Y
Yan Bi
Z
Zhou Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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