Food Intake-Related Brain and Metabolic Responses in Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About this trial
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
This trial accepts healthy volunteersQualifiers
BMI ≥ 28 kg/m²;
Age 18-40 years;
Any gender;
Right-handed.
Disqualifiers
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;
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;
Trial design
Design model
Crossover
Treatments tested in this trial
Glucose Liquid Meal
Dietary supplementA standardized, isocaloric (200 kcal), isovolumetric (300 mL) liquid meal containing 50 g pure glucose. Administered orally 6 hours after a standardized pre-load meal.
Fat Liquid Meal
Dietary supplementA standardized, isocaloric (200 kcal), isovolumetric (300 mL) liquid meal prepared from 100 mL of intralipid emulsion diluted with water. Administered orally 6 hours after a standardized pre-load meal.
Protein Liquid Meal
Dietary supplementA standardized, isocaloric (200 kcal), isovolumetric (300 mL) liquid meal containing 54 g whey protein isolate powder. Administered orally 6 hours after a standardized pre-load meal.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Glucose ChallengeExperimental treatment 1 intervention
Group B: Fat ChallengeExperimental treatment 1 intervention
Group C: Protein ChallengeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute Brain Functional Response to Macronutrient Challenges
Changes in whole-brain functional activation patterns assessed by blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI), comparing pre-challenge baseline with post-challenge scans acquired within 20 minutes after ingestion of glucose, fat, or protein.
Time frame
Baseline (pre-challenge) and within 0-20 minutes post-challenge on each experimental day2
Dynamic Plasma Metabolomic Response to Macronutrient Challenges
Temporal changes in plasma metabolic profiles characterized by untargeted metabolomic profiling, evaluating the evolution of metabolite concentrations across three time points: before intervention, 30 minutes post-intervention, and 120 minutes post-intervention, following single-dose challenges with glucose, fat, or protein.
Time frame
Baseline (pre-challenge), 30 minutes post-challenge, and 120 minutes post-challenge on each experimental day.Secondary outcomes
1
Temporal Changes in Subjective Satiety and Hunger Ratings
Subjective levels of satiety and hunger assessed using a standardized visual analog scale (VAS), with ratings collected at four time points: before nutrient challenge, immediately after ingestion (0 minutes), 30 minutes post-challenge, and 120 minutes post-challenge.
Time frame
Pre-challenge, 0 minutes, 30 minutes, and 120 minutes post-challenge on each experimental day.2
Inter-group Differences in Brain Functional and Metabolic Responses Between Obese and Healthy Participants
Comparison of whole-brain fMRI activation patterns and plasma metabolomic profiles between obese participants and healthy controls following glucose, fat, or protein challenges, to evaluate group-level differences in neuro-metabolic responsiveness.
Time frame
Baseline, within 0-20 minutes (fMRI), and 30/120 minutes (metabolomics) post-challenge on each experimental day3
Changes in Gut Microbiota Composition and Alpha/Beta Diversity Following Macronutrient Challenges
Fecal samples collected approximately 24 hours before and 24 hours after each macronutrient challenge are analyzed via 16S rRNA gene sequencing (or metagenomic sequencing) to assess changes in gut microbial composition, alpha diversity (within-sample), and beta diversity (between-sample).
Time frame
Approximately 24 hours before intervention and approximately 24 hours after intervention on each experimental daySponsors and contacts
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Source ClinicalTrials.gov