Food Intake-Related Brain and Metabolic Responses in Obesity

NCT07392905 | Recruiting

• 1 other identifier: 2025-0875-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Brain Function; Metabolomics; Feeding Behavior; Macronutrients

Keywords

obesity; macronutrient; fMRI; Cross-over trial; Plasma metabolome; Satiety; Nutrient challenge

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (pre-challenge) and within 0-20 minutes post-challenge on each experimental day

• 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.

  Baseline (pre-challenge), 30 minutes post-challenge, and 120 minutes post-challenge on each experimental day.

Secondary Outcomes (3)

• Temporal Changes in Subjective Satiety and Hunger Ratings

  Pre-challenge, 0 minutes, 30 minutes, and 120 minutes post-challenge on each experimental day.

• Inter-group Differences in Brain Functional and Metabolic Responses Between Obese and Healthy Participants

  Baseline, within 0-20 minutes (fMRI), and 30/120 minutes (metabolomics) post-challenge on each experimental day

• Changes in Gut Microbiota Composition and Alpha/Beta Diversity Following Macronutrient Challenges

  Approximately 24 hours before intervention and approximately 24 hours after intervention on each experimental day

Study Arms (3)

Glucose Challenge

EXPERIMENTAL

Participants receive a single 200 kcal liquid meal consisting of 50 g glucose powder dissolved in water to a final volume of 300 mL, administered 6 hours after consuming a standardized pre-load meal.

Dietary Supplement: Glucose Liquid Meal

Fat Challenge

EXPERIMENTAL

Participants receive a single 200 kcal liquid meal consisting of 100 mL intralipid emulsion diluted with water to a final volume of 300 mL, administered 6 hours after consuming a standardized pre-load meal.

Dietary Supplement: Fat Liquid Meal

Protein Challenge

EXPERIMENTAL

Participants receive a single 200 kcal liquid meal consisting of 54 g whey protein isolate powder dissolved in water to a final volume of 300 mL, administered 6 hours after consuming a standardized pre-load meal.

Dietary Supplement: Protein Liquid Meal

Interventions

Glucose Liquid Meal DIETARY_SUPPLEMENT

A standardized, isocaloric (200 kcal), isovolumetric (300 mL) liquid meal containing 50 g pure glucose. Administered orally 6 hours after a standardized pre-load meal.

Glucose Challenge

Fat Liquid Meal DIETARY_SUPPLEMENT

A 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.

Fat Challenge

Protein Liquid Meal DIETARY_SUPPLEMENT

A 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.

Protein Challenge

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Obese participants:
• BMI ≥ 28 kg/m²;
• Age 18-40 years;
• Any gender;
• Right-handed.
• Healthy control participants:
• BMI 18.5-23.9 kg/m²;
• Age 18-40 years;
• Any gender;
• Right-handed.

You may not qualify if:

• 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;
• Contraindications to MRI, such as implanted metallic devices or claustrophobia;
• Pregnancy or lactation;
• 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;
• History of prior metabolic/bariatric surgery;
• Use of antibiotics or probiotics within the past 1 month;
• 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;
• Unusual dietary habits; daily alcohol intake \>40 grams, smoking \>10 cigarettes per day, or coffee consumption ≥2 cups per day.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China 210008, China

RECRUITING

MeSH Terms

Conditions

Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Yan Bi

  Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Bi

CONTACT

6-25-83-105302; biyan@nju.edu.cn

Zhou Zhang

CONTACT

86-25-83-105302; zhangzhou@smail.nju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: December 21, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)