Article ; Online: Effect of transcranial direct current stimulation associated with hypocaloric diet on weight loss and metabolic profile in overweight or obesity: study protocol for a double-blind, randomized controlled clinical trial.
2018 Volume 19, Issue 1, Page(s) 386
Abstract: Background: Dietary interventions have limited success in promoting sustainable weight loss; new treatments allowing better compliance with hypocaloric diets should be developed. The aim of this trial is to describe the effects of a protocol combining ... ...
| Abstract | Background: Dietary interventions have limited success in promoting sustainable weight loss; new treatments allowing better compliance with hypocaloric diets should be developed. The aim of this trial is to describe the effects of a protocol combining repetitive active transcranial direct current stimulation (tDCS) with a hypocaloric diet on weight loss and food consumption in overweight or obese adults. Methods/design: Overweight or obese adults between 20 and 50 years of age with stable weight over the last 4 months will be selected for a 4-week randomized clinical trial of fixed-dose tDCS (20 sessions; 5 consecutive weekdays/wk, 2 mA, 20 minutes) over the right dorsolateral prefrontal cortex associated with a weight loss diet. The subjects will be randomly assigned in a 1:1 ratio and stratified by sex to active tDCS + diet or sham tDCS + diet. The study will be conducted at the Endocrine and Metabolism Unit of the Hospital de Clínicas de Porto Alegre, Brazil. The primary outcome is weight loss. Energy and macronutrient consumption, as well as adherence to the diet, will be assessed using 3-day weighed dietary records. Changes in blood glucose and plasma insulin will be assessed, and participants will complete self-report questionnaires to assess changes in mood and food behavior. All analyses will be done on a per-protocol and intention-to-treat basis. Discussion: This study explores the potential role of tDCS as an adjunctive treatment with a hypocaloric diet for obesity management. Trial registration: ClinicalTrials.gov , NCT02683902 . Registered on 11 January 2016. |
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| MeSH term(s) | Adult ; Basal Metabolism ; Blood Glucose/analysis ; Data Interpretation, Statistical ; Diet, Reducing ; Double-Blind Method ; Female ; Humans ; Insulin Resistance ; Male ; Middle Aged ; Obesity/therapy ; Overweight/therapy ; Randomized Controlled Trials as Topic ; Transcranial Direct Current Stimulation/methods ; Weight Loss ; Young Adult |
| Chemical Substances | Blood Glucose |
| Language | English |
| Publishing date | 2018-07-16 |
| Publishing country | England |
| Document type | Clinical Trial Protocol ; Journal Article |
| ZDB-ID | 2040523-6 |
| ISSN | 1745-6215 ; 1468-6694 ; 1745-6215 |
| ISSN (online) | 1745-6215 |
| ISSN | 1468-6694 ; 1745-6215 |
| DOI | 10.1186/s13063-018-2776-3 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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