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Ear nerve stimulation plus diet and exercise to reduce belly fat in overweight adults

Tests ear nerve stimulation added to diet and exercise in overweight or obese adults.

Plain-language title generated from the registry record
Registry title: Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity

Key facts

Where
Zhuhai, ChinaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 49 years old?

Source: NCT07907029, who can take part

Where in China

  • Zhuhai Hospital, Guangdong Provincial Hospital of Chinese MedicinZhuhai, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Guangdong Provincial Hospital of Traditional Chinese Medicine
Trial code
NCT07907029
Record updated
30 October 2026
Original description
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).Read full original descriptionShow less

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

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).

Inclusion: 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.

Exclusion: Contraindications to MRI (e.g., metallic implants, orthodontic appliances or braces, claustrophobia); Prior use of hormonal medications; History of neurological or psychiatric disorders; Intracranial lesions; Current pregnancy or lactation.

ClinicalTrials.gov NCT07907029