Abstract

BackgroundDietary 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/designOverweight 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.DiscussionThis study explores the potential role of tDCS as an adjunctive treatment with a hypocaloric diet for obesity management.Trial registrationClinicalTrials.gov, NCT02683902. Registered on 11 January 2016.

Highlights

  • Dietary interventions have limited success in promoting sustainable weight loss; new treatments allowing better compliance with hypocaloric diets should be developed

  • This study explores the potential role of transcranial direct current stimulation (tDCS) as an adjunctive treatment with a hypocaloric diet for obesity management

  • The behavioral drive to find and eat food is closely related to the rewarding feeling that this food provides, resulting in a strong motivation to engage in this behavior again, which frequently results in failure to maintain a hypocaloric diet [5, 6]

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Summary

Discussion

This is the first study to investigate whether sessions of repetitive tDCS over the right DLPFC may add additional benefits to weight loss in subjects undergoing a calorie-restricted diet. Most studies reporting a reduction in food craving have used the AR/CL electrode positioning over the DLPFC, which presumably increases activity in the right DLPFC (F4 position) and inhibits activity in the left DLPFC (F3 position) [10,11,12, 17, 57] This protocol was designed to include a total of 20 tDCS sessions on 20 consecutive weekdays, each lasting 20 minutes. Because eating behavior is an important component that can enhance adherence to prescribed diets, we believe that the potential of tDCS to modulate eating behavior could contribute to better adherence to dietary treatment and to weight loss and better quality of life Trial status This trial is currently ongoing. Abbreviations AR/CL: Anodal right/cathodal left; aRMR: Adjusted resting metabolic rate; BMI: Body mass index; CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration; DLPFC: Dorsolateral prefrontal cortex; EDTA: Ethylenediaminetetraacetic acid; FCI-Br: Food Craving Inventory– Brazilian version; FPG: Fasting plasma glucose; FPI: Fasting plasma insulin; GA: Glycated albumin; GEE: Generalized estimating equation; HDL: Highdensity lipoprotein; HOMA: Homeostatic model assessment; HOMAIR: Homeostatic model assessment of insulin resistance; LMTT: Liquid meal tolerance test; MAGE: Mean amplitude of glycemic excursion; OGTT: Oral glucose tolerance test; RMR: Resting metabolic rate; SF-36: 36-Item Short Form Health Survey; STAI: State-Trait Anxiety Inventory; tDCS: Transcranial direct current stimulation; TSH: Thyroid-stimulating hormone; UV: Ultraviolet; VAS: Visual analogue scale; WDR: Weighed dietary records

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