ObesityNCT05511376
Comparison of Different Weight Loss Methods in Obese Individuals
A study testing AURICULAR VAGUS NERVE STIMULATION, DIET and EXERCISE in people with Obesity, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- AURICULAR VAGUS NERVE STIMULATION, DIET and EXERCISE
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 26 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 18 - 65
- Being in the stage I, II and III obesity class
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Avicenna Hospital
Istanbul, 34750
Gözde IN, +905314906736, dytgozdein@gmail.com
About this study
Official title: Comparison of Diet, Exercise, and Auricular Vagus Nerve Stimulation Efficacy for Weight Reduction in Obese Individuals
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
- Being tested
- AURICULAR VAGUS NERVE STIMULATION, DIET, EXERCISE
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AURICULAR VAGUS NERVE STIMULATIONDevice
Also called Vagustim
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.
DIETBehavioural
Also called A Mediterranean-style, protein-based diet program
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)
EXERCISEBehavioural
Also called Moderate Resistance Exercise and Aerobic Exercise
Exercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: AURICULAR VAGUS NERVE STIMULATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Analysis
BIA measurements include (BMI (kg/m2)).
Measured: Study start
Body Analysis
BIA measurements include (BMI (kg/m2)).
Measured: 2nd week
Body Analysis
BIA measurements include (BMI (kg/m2)).
Measured: 4th week
Body Analysis
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Measured: Study start
Body Analysis
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Measured: 2nd week
Body Analysis
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Measured: 4th week
Body Analysis
BIA measurements include (Muscle and fat percentage (%) such as).
Measured: Study start
Body Analysis
BIA measurements include (Muscle and fat percentage (%) such as).
Measured: 2nd week
Body Analysis
BIA measurements include (Muscle and fat percentage (%) such as).
Measured: 4th week
Body Analysis
BIA measurement include (Body density (mg/dl)).
Measured: Study start
Body Analysis
BIA measurement include (Body density (mg/dl)).
Measured: 2nd week
Body Analysis
BIA measurement include (Body density (mg/dl)).
Measured: 4th week
Body Analysis
BIA measurement include (internal adiposity).
Measured: Study start
Body Analysis
BIA measurement include (internal adiposity).
Measured: 2nd week
Body Analysis
BIA measurement include (internal adiposity).
Measured: 4th week
Anthropometric Measurements
It includes length (m) measurement.
Measured: Study start
Anthropometric Measurements
It includes length (m) measurement.
Measured: 2nd week
Anthropometric Measurements
It includes length (m) measurement.
Measured: 4th week
Anthropometric Measurements
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Measured: Study start
Anthropometric Measurements
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Measured: 2nd week
Anthropometric Measurements
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Measured: 4th week
Anthropometric Measurements
It includes waist-hip ratio measurements.
Measured: Study start
Anthropometric Measurements
It includes waist-hip ratio measurements.
Measured: 2nd week
Anthropometric Measurements
It includes waist-hip ratio measurements.
Measured: 4th week
Biochemical parameters
It includes fasting blood sugar (mg/dL) value.
Measured: Study start & 4th week
Biochemical parameters
It includes fasting blood sugar (mg/dL) value.
Measured: Study start
Biochemical parameters
It includes HDL (mg/dL), LDL (mg/dL), TG (mg/dL), and Total cholesterol (mg/dL) values.
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 4th week
Handgrip strength test
The Handgrip strength test (kg) measurement evaluates muscle strength.
Measured: Study start
Handgrip strength test
The Handgrip strength test (kg) measurement evaluates muscle strength.
Measured: 2nd week
Handgrip strength test
The Handgrip strength test (kg) measurement evaluates muscle strength.
Measured: 4th week
Secondary outcomes (4)
International Physical Activity Questionnaire (Short Form- IPAQ)
It has been used to examine physical activity levels. (Weekly physical activity levels are measured by MET value calculations. An increase in MET values indicates an increase in activity.)
Measured: Study start, 2nd & 4th week
Quality of Life Questionnaire (Short Form - SF-36)
It was used to evaluate the effect of weight on quality of life. (It is evaluated in the range of 0 - 100 points. Energy/vitality, physical function, mental health, general health perception, social functionality scores show a positive development as they approach the maximum value. Physical role difficulty, emotional role difficulty and Pain scores show a positive development as they approach the minimum value.)
Measured: Study start, 2nd & 4th week
Food Cravings Questionnaire (FCQ)
It was used to determine the cravings for foods. (In the scale, a scoring system between 39-234 points is used for sub-dimensions.It shows that there is a positive development as the scale approaches the minimum result.)
Measured: Study start & 4th week
Visual Analog Scale (VAS)
It was used to determine the cravings for foods. (A scoring system from 0 to 10 is used.It shows that there is a positive development as the scale approaches the minimum result.)
Measured: Study start, 2nd & 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jul 2021
- Primary completion1 Aug 2022
- Study completion26 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gozde In, Bahçeşehir University
- Investigators
- Gözde IN, Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511376
- Sponsor's protocol ID
- BAUGOZDEIN1318303
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diet, Exercise, and Auricular Vagus Nerve Stimulation Efficacy for Weight Reduction in Obese Individuals
- ClinicalTrials.gov ID
- NCT05511376
- Acronym / sponsor ID
- BAUGOZDEIN1318303
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DIET | Active comparator | Behavioral: DIETPersonal nutrition programs were prepared according to ideal body weight, with protein intake as 30% of total daily calories or 1-1.2 g/kg. |
| EXERCISE | Active comparator | Behavioral: EXERCISEA 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. |
| AURICULAR VAGUS NERVE STIMULATION | Active comparator | Device: AURICULAR VAGUS NERVE STIMULATIONThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age range 18 - 65
- Being in the stage I, II and III obesity class
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AURICULAR VAGUS NERVE STIMULATIONAlso: VagustimFor 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. | Device | AURICULAR VAGUS NERVE STIMULATION |
| DIETAlso: A Mediterranean-style, protein-based diet programFor 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) | Behavioural | DIET |
| EXERCISEAlso: Moderate Resistance Exercise and Aerobic ExerciseExercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week) | Behavioural | EXERCISE |
Primary outcome
Body Analysis
Time frame: Study start
BIA measurements include (BMI (kg/m2)).
Body Analysis
Time frame: 2nd week
BIA measurements include (BMI (kg/m2)).
Body Analysis
Time frame: 4th week
BIA measurements include (BMI (kg/m2)).
Body Analysis
Time frame: Study start
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Body Analysis
Time frame: 2nd week
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Body Analysis
Time frame: 4th week
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Body Analysis
Time frame: Study start
BIA measurements include (Muscle and fat percentage (%) such as).
Body Analysis
Time frame: 2nd week
BIA measurements include (Muscle and fat percentage (%) such as).
Body Analysis
Time frame: 4th week
BIA measurements include (Muscle and fat percentage (%) such as).
Body Analysis
Time frame: Study start
BIA measurement include (Body density (mg/dl)).
Body Analysis
Time frame: 2nd week
BIA measurement include (Body density (mg/dl)).
Body Analysis
Time frame: 4th week
BIA measurement include (Body density (mg/dl)).
Body Analysis
Time frame: Study start
BIA measurement include (internal adiposity).
Body Analysis
Time frame: 2nd week
BIA measurement include (internal adiposity).
Body Analysis
Time frame: 4th week
BIA measurement include (internal adiposity).
Anthropometric Measurements
Time frame: Study start
It includes length (m) measurement.
Anthropometric Measurements
Time frame: 2nd week
It includes length (m) measurement.
Anthropometric Measurements
Time frame: 4th week
It includes length (m) measurement.
Anthropometric Measurements
Time frame: Study start
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Anthropometric Measurements
Time frame: 2nd week
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Anthropometric Measurements
Time frame: 4th week
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Anthropometric Measurements
Time frame: Study start
It includes waist-hip ratio measurements.
Anthropometric Measurements
Time frame: 2nd week
It includes waist-hip ratio measurements.
Anthropometric Measurements
Time frame: 4th week
It includes waist-hip ratio measurements.
Biochemical parameters
Time frame: Study start & 4th week
It includes fasting blood sugar (mg/dL) value.
Biochemical parameters
Time frame: Study start
It includes fasting blood sugar (mg/dL) value.
Biochemical parameters
Time frame: 4th week
It includes HDL (mg/dL), LDL (mg/dL), TG (mg/dL), and Total cholesterol (mg/dL) values.
Biophysical Methods
Time frame: Study start
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.)
Biophysical Methods
Time frame: 2nd week
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.)
Biophysical Methods
Time frame: 4th week
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.)
Biophysical Methods
Time frame: Study start
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.)
Biophysical Methods
Time frame: 2nd week
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.)
Biophysical Methods
Time frame: 4th week
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.)
Biophysical Methods
Time frame: Study start
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.)
Biophysical Methods
Time frame: 2nd week
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.)
Biophysical Methods
Time frame: 4th week
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.)
6-Min Walk Test
Time frame: Study start
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
6-Min Walk Test
Time frame: 2nd week
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
6-Min Walk Test
Time frame: 4th week
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
6-Min Walk Test
Time frame: Study start
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.)
6-Min Walk Test
Time frame: 2nd week
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.)
6-Min Walk Test
Time frame: 4th week
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.)
6-Min Walk Test
Time frame: Study start
The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)
6-Min Walk Test
Time frame: 2nd week
The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)
6-Min Walk Test
Time frame: 4th week
The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)
6-Min Walk Test
Time frame: Study start
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.)
6-Min Walk Test
Time frame: 2nd week
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.)
6-Min Walk Test
Time frame: 4th week
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.)
6-Min Walk Test
Time frame: Study start
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
6-Min Walk Test
Time frame: 2nd week
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
6-Min Walk Test
Time frame: 4th week
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
Handgrip strength test
Time frame: Study start
The Handgrip strength test (kg) measurement evaluates muscle strength.
Handgrip strength test
Time frame: 2nd week
The Handgrip strength test (kg) measurement evaluates muscle strength.
Handgrip strength test
Time frame: 4th week
The Handgrip strength test (kg) measurement evaluates muscle strength.
4 secondary outcomes
International Physical Activity Questionnaire (Short Form- IPAQ)
Time frame: Study start, 2nd & 4th week
Quality of Life Questionnaire (Short Form - SF-36)
Time frame: Study start, 2nd & 4th week
Food Cravings Questionnaire (FCQ)
Time frame: Study start & 4th week
Visual Analog Scale (VAS)
Time frame: Study start, 2nd & 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gözde IN principal investigator
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AURICULAR VAGUS NERVE STIMULATION, DIET and EXERCISE in people with Obesity, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gözde IN (+905314906736, dytgozdein@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Analysis (time frame: Study start). The study lists 54 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.