Obesity Clinical Trial
— taVNSOfficial title:
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals: a Randomized, Sham-controlled, Double Blind Clinical Trial.
Background: Obesity is one of the most important diseases around the globe; with a continuous
increase and public health concern. Current treatments present some limitations. Craving is a
symptom usually noticeable and has been described as a "strong desire or urge to use",
especially with foods. The vagus nerve and its relations to the neurocircuitry of the reward
system play essential roles in food intake regulation and this can be done transcutaneously
trough the auricular branch of the vagus nerve (taVNS). Based on the neurobiology of food
craving and on the initial data on taVNS demonstrating safety and efficacy in open-label and
randomized sham controlled trials, the investigators propose the first randomized, sham
controlled, triple-blind trial on taVNS for food craving in obesity.
Methods: This will be a two-arm, triple-blinded, randomized controlled trial with 54 subjects
with food craving assigned to either: 1) a 10-session treatment protocol of real taVNS, or 2)
a 10-session treatment protocol of sham taVNS, besides qualitative electroencephalogram
(qEEG) and heart rate variability (HRV). Participants will be evaluated for primary outcome
measures (Food Craving Questionnaire - State [FCQ-S] and Food Craving Questionnaire - Trait
[FCQ-T]) before and after intervention, with a follow-up visit of 30 days after the end of
treatment. A comparison between sham and active groups will be performed in three occasions
[baseline (T1), at the end of the stimulation protocol (T2) and 30 days after the last day of
stimulation (T3)].
Discussion: Given the epidemiological situation and economic and social burdens, the
possibility of modulating the reward system neurocircuitry trough the vagus nerve with an
easy-to-use, low-cost, safe and potential at-home use could represent a breakthrough in
treating obesity. The investigators hypothesized that food craving in obese individuals would
decrease at least 50%, as well as their intake of high fat, high sugar and processed food,
commonly described as palatable foods. Beyond that, the investigators expect that these
individuals would improve anxiety symptoms.
Status | Not yet recruiting |
Enrollment | 54 |
Est. completion date | October 2019 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Body mass index (BMI)>29 - Age between 18 and 55 years old - Food Craving Questionnaire-State and Trait (FCQ-S and FCQ-T)>108 - Agreement to participate and sign the informed consent term before any procedure is conducted. Exclusion Criteria: - History of head injury or epilepsy - Body metallic implants and pacemaker - Current use or in the previous six months of psychotropic or anorexigenic medications, recreational drugs and/or participation in weight-loss programs - Pregnancy or breastfeeding - Indication of hospitalization - Substance dependence - Psychiatric disorder, except for anxiety disorders - Personality disorders - Suicidal ideation - Non-controlled clinical comorbidities. |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of São Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of 40% of food craving symptoms | Changes in food craving will be evaluated by the Brazilian version of the FCQ-S and FCQ-T. A comparison between sham and active groups will be performed in three occasions. | Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation. | |
Secondary | Decrease of 10% of BMI and hip/waist ratio | Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation. | ||
Secondary | Improve metabolic profile. | Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation. | ||
Secondary | Improve anxiety symptoms evaluated by the Inventory for Depressive Symptoms (Self-Report version). | Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation. |
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