NCT05511376

Comparison of Different Weight Loss Methods in Obese Individuals

Comparison of Diet, Exercise, and Auricular Vagus Nerve Stimulation Efficacy for Weight Reduction in Obese Individuals

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Bahçeşehir University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Although obesity is a rapidly increasing epidemic worldwide, it is associated with many health-related comorbidities. As a result of the developments in social life and observes the sedentary life in individuals, an effect of the age of technology the fact that this epidemic will cause even massive health problems in the coming period affecting the health systems of countries and indirectly their economies that, This situation necessitates the creation of alternative treatment methods for the prevention of obesity. This study aims to determine the effect of a therapy approach that can be applied to the vagus nervous system, which is associated with many organs and systems, on weight loss and general health. As an alternative treatment against lifestyle changes such as diet and exercise, individuals have made for weight loss.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	AURICULAR VAGUS NERVE STIMULATION	For 4 weeks With the Vagustim device, in Biphasic, Frequency 10 Hz, Modulation mode, the pulse width of 300 μs, where the participants feel comfortable, the current intensity is kept constant for 30 minutes / 3 days/week. It will be applied as bilateral VSS from the tragus and turbinate parts of the ear.
BEHAVIORAL	DIET	For 4 weeks, Protein intake to 30% of total daily calories or 1-1.2 g/kg Personal nutrition program created for ideal body weight (by BMI values for age)
BEHAVIORAL	EXERCISE	Exercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week)

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-08-01
• Completion: 2022-08-26
• First posted: 2022-08-23
• Last updated: 2022-08-24

Locations

1 site across 1 country: Turkey (Türkiye)