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Investigating the Microbiota-Gut-Brain Axis Mechanisms of Transcutaneous
Auricular Vagus Nerve Stimulation in Patients with Obesity: A Study Protocol for
a Randomized Controlled Trial
#MMPMID41141981
Chen X
; Kong W
; Song Y
; Huang W
; Zhang Y
; Liu Z
; Zhou Z
; Fu C
Diabetes Metab Syndr Obes
2025[]; 18
(?): 3895-3904
PMID41141981
show ga
BACKGROUND: Obesity is a common metabolic disorder affecting nearly one-third of
the global population. Emerging evidence indicates that the microbiota-gut-brain
axis plays a key role in the pathogenesis of obesity. Transcutaneous auricular
vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, may
modulate brain function and gut microbiota via vagal pathways. This study aims to
evaluate the short-term efficacy of taVNS in reducing body weight in patients
with obesity and to explore its underlying mechanisms by assessing changes in
neural activity and gut microbial composition. METHODS: This single-center,
randomized controlled trial will enroll 74 patients with obesity, who will be
randomized in a 1:1 ratio to receive either taVNS (electrical stimulation
delivered to the left cymba conchae) or sham taVNS (stimulation at the tail of
the helix). The primary outcome will be the percentage change in body weight from
baseline to Week 12. Secondary outcomes will include anthropometric measures such
as changes in body mass index (BMI), waist circumference, hip circumference, body
fat percentage, and visceral fat area. Clinical evaluations will be conducted
using validated instruments, including the Impact of Weight on Quality of
Life-Lite (IWQOL-Lite), Perceived Stress Scale (PSS), Hamilton Depression Rating
Scale (HAMD), Dutch Eating Behavior Questionnaire (DEBQ), International Physical
Activity Questionnaire (IPAQ), and the Fatigue Scale-14 (FS-14). To investigate
modulation of the microbiota-gut-brain (MGB) axis, assessments will include serum
brain-gut peptides, gut microbiota composition, and functional magnetic resonance
imaging (fMRI). Adverse events will also be systematically monitored throughout
the study period. DISCUSSION: This study will preliminarily validate the clinical
efficacy of taVNS for obesity. And by integrating measures such as gut peptides,
microbiota profiling, and brain imaging, it seeks to link therapeutic effects
with microbiota-gut-brain axis modulation. The findings may support taVNS as a
safe, non-pharmacological approach for obesity management and inform future
neuromodulation-based strategies. TRIAL REGISTRATION NUMBER: ITMCTR2024000518.
http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=d4ae9741-2788-433a-9242-a5fe78929bce.
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