Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity

Condition(s) studied

Investigational drug(s) / intervention(s)

transcutaneous auricular vagus nerve stimulation (taVNS): 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.

Standardized lifestyle program (calorie-restricted diet plus aerobic exercise): 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.

Study summary

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).

Eligibility

Primary outcome measure(s)

• Change in visceral fat index (VFI) — Baseline (week 0) and post-intervention (week 4)
  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.

Trial sites (1)

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