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Association Between Food Intake-Related Brain Functional Patterns and Metabolic Profiles in Patients With Obesity: A Randomized Crossover Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
China
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
RECRUITING
Nanjing
Contact Information
Primary
Yan Bi
biyan@nju.edu.cn
6-25-83-105302
Backup
Zhou Zhang
zhangzhou@smail.nju.edu.cn
86-25-83-105302
Time Frame
Start Date: 2025-12-21
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 60
Treatments
Experimental: Glucose Challenge
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.
Experimental: Fat Challenge
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.
Experimental: Protein Challenge
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.
Related Therapeutic Areas
Sponsors
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov