NCT05511376

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

August 4, 2022

Last Update Submit

August 22, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (54)

  • Body Analysis

    BIA measurements include (BMI (kg/m2)).

    Study start

  • Body Analysis

    BIA measurements include (BMI (kg/m2)).

    2nd week

  • Body Analysis

    BIA measurements include (BMI (kg/m2)).

    4th week

  • Body Analysis

    BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).

    Study start

  • Body Analysis

    BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).

    2nd week

  • Body Analysis

    BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).

    4th week

  • Body Analysis

    BIA measurements include (Muscle and fat percentage (%) such as).

    Study start

  • Body Analysis

    BIA measurements include (Muscle and fat percentage (%) such as).

    2nd week

  • Body Analysis

    BIA measurements include (Muscle and fat percentage (%) such as).

    4th week

  • Body Analysis

    BIA measurement include (Body density (mg/dl)).

    Study start

  • Body Analysis

    BIA measurement include (Body density (mg/dl)).

    2nd week

  • Body Analysis

    BIA measurement include (Body density (mg/dl)).

    4th week

  • Body Analysis

    BIA measurement include (internal adiposity).

    Study start

  • Body Analysis

    BIA measurement include (internal adiposity).

    2nd week

  • Body Analysis

    BIA measurement include (internal adiposity).

    4th week

  • Anthropometric Measurements

    It includes length (m) measurement.

    Study start

  • Anthropometric Measurements

    It includes length (m) measurement.

    2nd week

  • Anthropometric Measurements

    It includes length (m) measurement.

    4th week

  • Anthropometric Measurements

    It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.

    Study start

  • Anthropometric Measurements

    It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.

    2nd week

  • Anthropometric Measurements

    It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.

    4th week

  • Anthropometric Measurements

    It includes waist-hip ratio measurements.

    Study start

  • Anthropometric Measurements

    It includes waist-hip ratio measurements.

    2nd week

  • Anthropometric Measurements

    It includes waist-hip ratio measurements.

    4th week

  • Biochemical parameters

    It includes fasting blood sugar (mg/dL) value.

    Study start & 4th week

  • Biochemical parameters

    It includes fasting blood sugar (mg/dL) value.

    Study start

  • Biochemical parameters

    It includes HDL (mg/dL), LDL (mg/dL), TG (mg/dL), and Total cholesterol (mg/dL) values.

    4th week

  • Biophysical Methods

    It includes 5 X Sit-to-Stand Up test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)

    Study start

  • Biophysical Methods

    It includes 5 X Sit-to-Stand Up test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)

    2nd week

  • Biophysical Methods

    It includes 5 X Sit-to-Stand Up test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)

    4th week

  • Biophysical Methods

    It includes the Stair Climb test (sec). ( It shows the temporal variation values in performing a particular activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)

    Study start

  • Biophysical Methods

    It includes the Stair Climb test (sec). ( It shows the temporal variation values in performing a particular activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)

    2nd week

  • Biophysical Methods

    It includes the Stair Climb test (sec). ( It shows the temporal variation values in performing a particular activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)

    4th week

  • Biophysical Methods

    It includes The Timed Up and Go Test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)

    Study start

  • Biophysical Methods

    It includes The Timed Up and Go Test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)

    2nd week

  • Biophysical Methods

    It includes The Timed Up and Go Test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)

    4th week

  • 6-Min Walk Test

    The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)

    Study start

  • 6-Min Walk Test

    The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)

    2nd week

  • 6-Min Walk Test

    The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)

    4th week

  • 6-Min Walk Test

    The 6-minute walk test includes value Blood pressure (mmHg) measurements. (High blood pressure measurements approaching the normal value indicate that functional values develop positively.)

    Study start

  • 6-Min Walk Test

    The 6-minute walk test includes value Blood pressure (mmHg) measurements. (High blood pressure measurements approaching the normal value indicate that functional values develop positively.)

    2nd week

  • 6-Min Walk Test

    The 6-minute walk test includes value Blood pressure (mmHg) measurements. (High blood pressure measurements approaching the normal value indicate that functional values develop positively.)

    4th week

  • 6-Min Walk Test

    The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)

    Study start

  • 6-Min Walk Test

    The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)

    2nd week

  • 6-Min Walk Test

    The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)

    4th week

  • 6-Min Walk Test

    The 6-minute walk test includes value Heart Rate. (Heart rate values being within the normal range for age indicate that functional values develop positively.)

    Study start

  • 6-Min Walk Test

    The 6-minute walk test includes value Heart Rate. (Heart rate values being within the normal range for age indicate that functional values develop positively.)

    2nd week

  • 6-Min Walk Test

    The 6-minute walk test includes value Heart Rate. (Heart rate values being within the normal range for age indicate that functional values develop positively.)

    4th week

  • 6-Min Walk Test

    The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)

    Study start

  • 6-Min Walk Test

    The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)

    2nd week

  • 6-Min Walk Test

    The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)

    4th week

  • Handgrip strength test

    The Handgrip strength test (kg) measurement evaluates muscle strength.

    Study start

  • Handgrip strength test

    The Handgrip strength test (kg) measurement evaluates muscle strength.

    2nd week

  • Handgrip strength test

    The Handgrip strength test (kg) measurement evaluates muscle strength.

    4th week

Secondary Outcomes (4)

  • International Physical Activity Questionnaire (Short Form- IPAQ)

    Study start, 2nd & 4th week

  • Quality of Life Questionnaire (Short Form - SF-36)

    Study start, 2nd & 4th week

  • Food Cravings Questionnaire (FCQ)

    Study start & 4th week

  • Visual Analog Scale (VAS)

    Study start, 2nd & 4th week

Study Arms (3)

DIET

ACTIVE COMPARATOR

Personal nutrition programs were prepared according to ideal body weight, with protein intake as 30% of total daily calories or 1-1.2 g/kg.

Behavioral: DIET

EXERCISE

ACTIVE COMPARATOR

A pre-exercise breathing exercise study was planned. Exercise: It was planned to apply the Moderate Resistant Exercise Protocol (3 days a week for 60 minutes) and as aerobic exercise, walking 5 days a week (150 minutes / week) as 30 minutes / day.

Behavioral: EXERCISE

AURICULAR VAGUS NERVE STIMULATION

ACTIVE COMPARATOR

The Vagustim device was applied in Biphasic, Frequency 10 Hz, Modulation mode, with a pulse width of 300 μs, for 30 minutes /3 days/week by keeping the current intensity constant where the participants felt comfortable. It will be applied as bilateral VSS from the tragus and turbinate parts of the ear.

Device: AURICULAR VAGUS NERVE STIMULATION

Interventions

AURICULAR VAGUS NERVE STIMULATIONDEVICE

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.

Also known as: Vagustim
AURICULAR VAGUS NERVE STIMULATION
DIETBEHAVIORAL

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)

Also known as: A Mediterranean-style, protein-based diet program
DIET
EXERCISEBEHAVIORAL

Exercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week)

Also known as: Moderate Resistance Exercise and Aerobic Exercise
EXERCISE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range 18 - 65
  • Being in the stage I, II and III obesity class

You may not qualify if:

  • Those with unstable DM
  • Those with stage II hypertension
  • Those who have had cardiovascular disease (especially those who have had an attack)
  • Those with pulmonary disease
  • Those with kidney disease
  • Orthopedic restrictions
  • Those with MND
  • Those tied to the chair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avicenna Hospital

Istanbul, 34750, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gözde IN

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gözde IN

CONTACT

+905314906736dytgozdein@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
EXPERT PHYSIOTHERAPIST AND DIETICIAN

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 23, 2022

Study Start

July 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 26, 2022

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)