Obesity
Conditions
Brief summary
Trans Cutanous Electric Nerve Stimulation of Auricular Vagus Nerve
Interventions
DEVICETranscutanous Auricular vagus nerve stimulation
Non-invasive Auricular Vagus Stimulation
DEVICESham
Non working device
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
25 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Sixty male * Age ranges from 25 to 35 * All them are medically stable with no chronic disease * waist circumference more than 94 * Body Mass Index more than or equal 30
Exclusion criteria
* Individuals with metabolic diseases * Individuals taking cholesterol lowering drugs, Anti-hypertensive drugs, Oral-hypoglycemic drugs * smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum Interleukin-6 (IL-6) | Baseline and after 4 weeks of intervention | serum Interleukin-6 levels will be measured using (ELIZA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | Baseline and after 4 weeks of intervention | Measurement of waist circumference in centimeters as an indicator of central adiposity |
| Body Shape Index (ABSI) | Baseline and after 4 weeks of intervention | Assessment of body shape using A Body Shape Index calculated from waist circumference, height, and weight. |
| Depression Anxiety Stress Scale (DASS-21) Score | Baseline and after 4 weeks of intervention | Evaluation of psychological status including depression, anxiety, and stress using the validated Depression Anxiety Stress Scale -21 questionnaire Higher scores indicate greater severity of emotional state The total score represents the sum of all 21 items multiplied by two. Sub scale scores for depression, anxiety and stress will be calculated and analyzed separately. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline and after 4 weeks of intervention | Assessment of sleep quality using the Pittsburgh Sleep Quality Index questionnaire. The total score ranges from 0 to 21 Score greater than 5 indicate poor sleep quality. |
| Gut Feeling Questionnaire Score | Baseline and after 4 weeks of intervention | Evaluation of gut-related symptoms and gut-brain interaction using a gut feeling questionnaire The total score is calculated by summing all questionnaire items, with higher scores indicating worse gut feelings. |
Contacts
CONTACTLamiaa Z Salama, MSc
PRINCIPAL_INVESTIGATORNessreen G Al-Nahas, Professor
Cairo University
Outcome results
None listed