ObesityNCT07392905
Food Intake-Related Brain and Metabolic Responses in Obesity
A study testing Glucose Liquid Meal, Fat Liquid Meal and Protein Liquid Meal in people with Obesity and Brain Function, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Brain Function, Metabolomics
- What is being tested?
- Glucose Liquid Meal, Fat Liquid Meal and Protein Liquid Meal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obese participants:
- BMI ≥ 28 kg/m²;
- Age 18-40 years;
- Any gender;
- Right-handed.
- Healthy control participants:
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- BMI 18.5-23.9 kg/m²;
- Age 18-40 years;
- Any gender;
- Right-handed.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China 210008
Yan Bi, 6-25-83-105302, biyan@nju.edu.cn
Zhou Zhang, 86-25-83-105302, zhangzhou@smail.nju.edu.cn
About this study
Official title: Association Between Food Intake-Related Brain Functional Patterns and Metabolic Profiles in Patients With Obesity: A Randomized Crossover 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.
Read the detailed description
This study is a prospective, single-center, randomized, controlled, crossover intervention trial enrolling 60 participants, including 30 obese patients and 30 healthy control volunteers. Each participant will be randomly assigned to one of the six possible sequences of three macronutrient interventions (A: glucose, B: fat, C: protein)-namely ABC, ACB, BAC, BCA, CAB, or CBA-to ensure balanced allocation across intervention orders. Each participant will undergo one nutrient challenge on each of three separate experimental days, with at least a 7-day washout period between visits to minimize carryover effects from prior interventions. During the washout periods, participants are required to maintain stable habitual dietary patterns and avoid extreme diets, high-intensity exercise, irregular sleep schedules, and intake of additional nutritional supplements; adherence will be monitored via brief diet and activity logs.
The intervention consists of isocaloric (200 kcal) and isovolumetric (300 mL) liquid meals, specifically formulated as follows: Glucose arm: 50 g glucose powder dissolved in water to a final volume of 300 mL; Fat arm: 100 mL intralipid emulsion diluted with water to a final volume of 300 mL; Protein arm: 54 g whey protein powder dissolved in water to a final volume of 300 mL. On each experimental day, participants must arrive in a fasting state. Prior to nutrient administration, they will complete clinical laboratory tests, body composition assessment, hepatic fat quantification, and eating behavior questionnaires. During and after the intervention, participants will provide dynamic postprandial satiety ratings, multi-timepoint blood and stool samples (for untargeted metabolomic analysis), and undergo functional magnetic resonance imaging (fMRI) within a predefined postprandial time window. Finally, neuroimaging metrics, peripheral metabolomic profiles, and subjective satiety scores will be integrated through multidimensional correlation analyses to explore the neuro-metabolic coupling responses to different macronutrient challenges in obesity, thereby providing theoretical insights and potential targets for precision nutrition interventions.
- Conditions
- Obesity, Brain Function, Metabolomics, Feeding Behavior, Macronutrients
- Being tested
- Glucose Liquid Meal, Fat Liquid Meal, Protein Liquid Meal
- Keywords
- obesity, macronutrient, fMRI, Cross-over trial, Plasma metabolome, Satiety, Nutrient challenge
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose Liquid MealDietary 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.
Fat Liquid MealDietary 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.
Protein Liquid MealDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Protein Liquid Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: Approximately 24 hours before intervention and approximately 24 hours after intervention on each experimental day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start21 Dec 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Bi, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yan Bi, Principal investigator, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392905
- Sponsor's protocol ID
- 2025-0875-02
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Food Intake-Related Brain Functional Patterns and Metabolic Profiles in Patients With Obesity: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07392905
- Acronym / sponsor ID
- 2025-0875-02
- Conditions
- Obesity, Brain Function, Metabolomics, Feeding Behavior, Macronutrients
- Keywords
- obesity, macronutrient, fMRI, Cross-over trial, Plasma metabolome, Satiety, Nutrient challenge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 21 Dec 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, single-center, randomized, controlled, crossover intervention trial enrolling 60 participants, including 30 obese patients and 30 healthy control volunteers. Each participant will be randomly assigned to one of the six possible sequences of three macronutrient interventions (A: glucose, B: fat, C: protein)-namely ABC, ACB, BAC, BCA, CAB, or CBA-to ensure balanced allocation across intervention orders. Each participant will undergo one nutrient challenge on each of three separate experimental days, with at least a 7-day washout period between visits to minimize carryover effects from prior interventions. During the washout periods, participants are required to maintain stable habitual dietary patterns and avoid extreme diets, high-intensity exercise, irregular sleep schedules, and intake of additional nutritional supplements; adherence will be monitored via brief diet and activity logs.
The intervention consists of isocaloric (200 kcal) and isovolumetric (300 mL) liquid meals, specifically formulated as follows: Glucose arm: 50 g glucose powder dissolved in water to a final volume of 300 mL; Fat arm: 100 mL intralipid emulsion diluted with water to a final volume of 300 mL; Protein arm: 54 g whey protein powder dissolved in water to a final volume of 300 mL. On each experimental day, participants must arrive in a fasting state. Prior to nutrient administration, they will complete clinical laboratory tests, body composition assessment, hepatic fat quantification, and eating behavior questionnaires. During and after the intervention, participants will provide dynamic postprandial satiety ratings, multi-timepoint blood and stool samples (for untargeted metabolomic analysis), and undergo functional magnetic resonance imaging (fMRI) within a predefined postprandial time window. Finally, neuroimaging metrics, peripheral metabolomic profiles, and subjective satiety scores will be integrated through multidimensional correlation analyses to explore the neuro-metabolic coupling responses to different macronutrient challenges in obesity, thereby providing theoretical insights and potential targets for precision nutrition interventions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose Challenge | Experimental | Dietary Supplement: Glucose Liquid MealParticipants 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. |
| Fat Challenge | Experimental | Dietary Supplement: Fat Liquid MealParticipants 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. |
| Protein Challenge | Experimental | Dietary Supplement: Protein Liquid MealParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- BMI ≥ 28 kg/m²;
- Age 18-40 years;
- Any gender;
- Right-handed.
- BMI 18.5-23.9 kg/m²;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose Liquid MealA standardized, isocaloric (200 kcal), isovolumetric (300 mL) liquid meal containing 50 g pure glucose. Administered orally 6 hours after a standardized pre-load meal. | Dietary supplement | Glucose Challenge |
| Fat Liquid MealA 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. | Dietary supplement | Fat Challenge |
| Protein Liquid MealA 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. | Dietary supplement | Protein Challenge |
Primary outcome
Acute Brain Functional Response to Macronutrient Challenges
Time frame: Baseline (pre-challenge) and within 0-20 minutes post-challenge on each experimental day
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.
Dynamic Plasma Metabolomic Response to Macronutrient Challenges
Time frame: Baseline (pre-challenge), 30 minutes post-challenge, and 120 minutes post-challenge on each experimental day.
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.
3 secondary outcomes
Temporal Changes in Subjective Satiety and Hunger Ratings
Time frame: 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
Time frame: 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
Time frame: Approximately 24 hours before intervention and approximately 24 hours after intervention on each experimental day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Bi principal investigator
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose Liquid Meal, Fat Liquid Meal and Protein Liquid Meal in people with Obesity and Brain Function, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Bi (6-25-83-105302, biyan@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Brain Functional Response to Macronutrient Challenges (time frame: Baseline (pre-challenge) and within 0-20 minutes post-challenge on each experimental day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.