NCT07907029Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
A Single-Center, Randomized, Open-Label Controlled Trial With Blinded Outcome Assessment of Transcutaneous Auricular Vagus Nerve Stimulation Plus Lifestyle Intervention Versus Lifestyle Intervention Alone for Visceral Fat Reduction and Brain Functional Network Modulation in Adults With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 15 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Diseases
- Obesity
- NCT number
- NCT07907029
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Nov 2026 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to MRI (e.g., metallic implants, orthodontic appliances or braces, claustrophobia)
- Prior use of hormonal medications
Other illness
- History of neurological or psychiatric disorders
Other
- Intracranial lesions
- Current pregnancy or lactation
Who the study is looking for
- Aged 18-49 years
- Overweight or obesity, defined as BMI 24-32.5 kg/m2 according to Chinese criteria
- Habitual sedentary lifestyle (less than 2 hours of daily walking and fewer than 3 exercise sessions per month on average over the past 6 months)
- No metabolic diseases detected on routine physical examination
- Right-handed
Age in the registry: 18 years to 49 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhuhai Hospital, Guangdong Provincial Hospital of Chinese Medicin Coordinator of this site? Confirm its status | Zhuhai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.