An interventional study of transcutaneous auricular vagus nerve stimulation (taVNS) and Standardized lifestyle program (calorie-restricted diet plus aerobic exercise) in Overweight and Obesity, sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
This is a single-center, randomized, open-label controlled trial with blinded outcome assessment and data analysis. Fifty adults with overweight or obesity (body mass index [BMI] >= 24 kg/m2) and a sedentary lifestyle will be randomly assigned in a 1:1 ratio to one of two groups: (1) a transcutaneous auricular vagus nerve stimulation (taVNS) group, in which participants self-administer taVNS at the cymba conchae of both ears on alternating days (20 Hz, dense-disperse mode, twice daily, 30 minutes per session, 5 days per week for 4 weeks) in addition to a standardized lifestyle program; or (2) a control group receiving the lifestyle program alone. The lifestyle program prescribes a daily energy intake of 1,000-1,500 kcal (55-60% carbohydrate, 25-30% fat, 20% protein) plus aerobic exercise of at least 30 minutes per session, 3 times per week. The primary outcome is the change in visceral fat index (VFI) from baseline to week 4. Secondary outcomes include changes in body weight, BMI and body fat percentage, as well as changes in thalamocortical functional connectivity, effective (directed) connectivity, and whole-brain functional network topological properties assessed by resting-state functional magnetic resonance imaging (fMRI), and their associations with changes in obesity-related indicators. Assessments are performed at baseline (week 0) and after the 4-week intervention (week 4).
Obesity is a major public health burden, and there is growing interest in neuromodulation approaches that may facilitate weight management beyond conventional lifestyle intervention. The vagus nerve plays a key role in the regulation of appetite, energy homeostasis and visceral function. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that targets the auricular branch of the vagus nerve (ABVN) at the cymba conchae, and prior studies suggest it may aid weight reduction and metabolic improvement. The neural mechanisms underlying the effects of taVNS on visceral fat reduction remain unclear; thalamocortical circuitry and whole-brain functional network organization are plausible substrates linking vagal afferent input to eating behavior and energy regulation.
In this trial, 50 adults aged 18-49 years with overweight or obesity (BMI 24-32.5 kg/m2) and a habitual sedentary lifestyle will be recruited. After baseline evaluation, eligible participants will be randomly assigned in a 1:1 ratio to the taVNS group or the control group using a computer-generated block randomization sequence (fixed block size of 4, SPSS 26.0). All participants will follow the same standardized lifestyle program throughout the 4-week intervention period: a calorie-restricted diet (1,000-1,500 kcal/day; 55-60% carbohydrate, 25-30% fat, 20% protein) and aerobic exercise of at least 30 minutes per session, 3 times per week. Participants in the taVNS group will additionally self-administer taVNS using an electronic acupuncture stimulator (SDZ-II, Huatuo, Suzhou, China) in dense-disperse mode at 20 Hz; stimulation will be delivered to the cymba conchae of the left and right ears on alternating days at the maximum intensity tolerable without pain, twice daily (morning and afternoon), 30 minutes per session, 5 days per week for 4 consecutive weeks. All treatments are home-administered after standardized training, with real-time adherence monitoring through electronic diaries. Adverse events are recorded by participants in electronic diaries and reviewed weekly by study personnel.
Outcome assessors and data analysts are blinded to group allocation. Anthropometric and body-composition measures (height, weight, BMI, body fat percentage, visceral fat index by bioelectrical impedance analysis, BCA-2A, Tsinghua Tongfang, China) and resting-state fMRI (3.0-T scanner, Discovery MR750, GE Healthcare) are acquired at baseline (week 0) and post-intervention (week 4). The primary outcome is the change in visceral fat index (VFI) from baseline to week 4. Secondary outcomes include changes in body weight, BMI and body fat percentage; group-by-time changes in thalamocortical functional connectivity (network-based statistic); changes in effective connectivity among identified network nodes (spectral dynamic causal modeling with parametric empirical Bayes); changes in global and nodal topological properties of whole-brain functional networks (clustering coefficient, shortest path length, nodal degree, nodal efficiency; Schaefer-400 atlas); and associations between brain network changes and changes in obesity-related indicators.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 50 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Guangdong Provincial Hospital of Traditional Chinese Medicine is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants self-administer transcutaneous auricular vagus nerve stimulation (taVNS) at the cymba conchae of both ears on alternating days (electronic acupuncture stimulator SDZ-II, Huatuo, Suzhou, China; dense-disperse mode, 20 Hz; intensity individualized to the maximum tolerable without pain; two 30-minute sessions per day, morning and afternoon, 5 days per week for 4 weeks) in addition to the standardized lifestyle program. The lifestyle program prescribes a daily energy intake of 1,000-1,500 kcal (55-60% carbohydrate, 25-30% fat, 20% protein) plus aerobic exercise of at least 30 minutes per session, 3 times per week. Home-based treatment is performed after standardized training, with real-time adherence monitoring through electronic diaries. Adverse events are recorded in the diaries and reviewed weekly by study personnel.
Device: transcutaneous auricular vagus nerve stimulation (taVNS) · Behavioral: Standardized lifestyle program (calorie-restricted diet plus aerobic exercise)
Participants receive the standardized lifestyle program only: a calorie-restricted diet (1,000-1,500 kcal/day; 55-60% carbohydrate, 25-30% fat, 20% protein) plus aerobic exercise of at least 30 minutes per session, 3 times per week, for 4 weeks. No electrical stimulation is administered.
Behavioral: Standardized lifestyle program (calorie-restricted diet plus aerobic exercise)
taVNS is delivered with an electronic acupuncture stimulator (SDZ-II, Huatuo, Suzhou, China) in dense-disperse mode at 20 Hz. Stimulation is applied to the cymba conchae of the left and right ears on alternating days, at an intensity individualized to the maximum level tolerable without pain. Treatment consists of two 30-minute sessions per day (morning and afternoon), 5 days per week for 4 consecutive weeks, self-administered at home after standardized training with real-time adherence monitoring through electronic diaries.
Also known as: transcutaneous vagus nerve stimulation
The lifestyle program prescribes a daily energy intake of 1,000-1,500 kcal (55-60% carbohydrate, 25-30% fat, 20% protein) plus aerobic exercise of at least 30 minutes per session, 3 times per week.
Change in visceral fat index (VFI)
VFI is assessed by bioelectrical impedance analysis (BCA-2A, Tsinghua Tongfang, China), and the outcome is the within-participant change from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 4)
Change in body weight
Body weight is measured with participants in light clothing without shoes, and the outcome is the within-participant change in body weight (kg) from baseline to post-intervention, compared between groups.
Time frame: Baseline (week 0) and post-intervention (week 4)
Change in body mass index (BMI)
BMI is calculated as body weight (kg) divided by height (m) squared, and the outcome is the within-participant change in BMI (kg/m2) from baseline to post-intervention, compared between groups.
Time frame: Baseline (week 0) and post-intervention (week 4)
Change in body fat percentage (BFP)
Body composition is assessed by bioelectrical impedance analysis (BCA-2A, Tsinghua Tongfang, China), and the outcome is the within-participant change in body fat percentage (%) from baseline to post-intervention, compared between groups.
Time frame: Baseline (week 0) and post-intervention (week 4)
Group-by-time change in thalamocortical functional connectivity
Thalamocortical functional connectivity is computed from resting-state fMRI data using the AAL3 atlas, and the outcome is the group-by-time change in thalamocortical connectivity from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 4)
Change in effective (directed) connectivity among network nodes
Effective (directed) connectivity among the nodes showing significant connectivity changes is estimated from resting-state fMRI, and the outcome is the change in directed connectivity from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 4)
Change in global and nodal topological properties of whole-brain functional networks
Global (clustering coefficient, shortest path length) and nodal (nodal degree, nodal efficiency) topological properties of whole-brain functional networks are derived from resting-state fMRI using the Schaefer-400 atlas, and the outcome is the change in each network property from baseline to post-intervention.
Time frame: Baseline (week 0) and post-intervention (week 4)
Partial correlation coefficient between changes in brain network measures and changes in obesity-related indicators
For brain network measures showing significant between-group differences in change, the partial correlation coefficient between the change in each brain network measure and the change in each obesity-related indicator (visceral fat index, body weight, BMI, body fat percentage) will be computed within the taVNS group, adjusting for relevant baseline covariates. Unit of measure: correlation coefficient (range -1 to 1).
Time frame: Baseline (week 0) and post-intervention (week 4)
Plan to share: Yes — De-identified individual participant data that underlie the results reported in publications will be shared beginning 9 months and ending 36 months following article publication, with researchers who provide a methodologically sound proposal and appropriate ethical approval. Proposals should be directed to the corresponding author.
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 36 months following article publication
Access criteria: Available to researchers who provide a methodologically sound proposal and appropriate ethical approval. Proposals should be directed to the corresponding author. Data requestors will be required to sign a data access agreement.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 3 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial Hospital of Traditional Chinese Medicine