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Comparison of Different Weight Loss Methods in Obese Individuals

NCT05511376 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-08-24

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Bahçeşehir University

    lead OTHER

Principal Investigators

  • Gözde IN · Bahçeşehir University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-08-01
Completion
2022-08-26

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05511376 on ClinicalTrials.gov