The Effect of Hypocaloric Diet Associated With tDCS on Weight Loss and Metabolic Profile

NCT02683902 | Unknown

• 1 other identifier: 15-0119
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To compare four weeks of transcranial direct current stimulation (tDCS) versus placebo associated with a reduced caloric diet on weight loss, glycemic control and regulators of hunger and satiety in overweight or obese subjects with different degrees of glucose tolerance, submitted to hypocaloric diet.

Conditions

Prediabetes; Obesity; Weight Loss; Diabetes; Overweight

Keywords

prediabetes; tDCS; transcranial direct current stimulation; obesity; diabetes

Outcome Measures

Primary Outcomes (1)

• Weight loss

  3% weight loss

  4 weeks

Secondary Outcomes (7)

• Changes in hormone levels after 4 week treatment

  baseline and 4 weeks

• Glycated Albumin

  baseline and 4 weeks

• Fasting Plasma Glucose

  baseline and 4 weeks

• Homeostatic Model Assessment (HOMA)

  4 weeks

• Body Mass Index (BMI)

  4 weeks

Study Arms (2)

Active tDCS + Diet

ACTIVE COMPARATOR

The participants will receive active tDCS treatment every day for 5 days per week, a total of 20 sessions. They will also be prescribed a hypocaloric dietary during these 4-week treatment.

Device: Active tDCS; Behavioral: Hypocaloric diet

Sham tDCS + Diet

SHAM COMPARATOR

The participants will receive sham tDCS treatment every day for 5 days per week, a total of 20 sessions. They will also be prescribed a hypocaloric dietary during these 4-week treatment.

Behavioral: Hypocaloric diet; Device: Sham tDCS

Interventions

Active tDCS DEVICE

The anode electrode will be placed over F4 position and the cathode electrode over F3, right and left respectively (using EEG 10/20 system). The electric current will be ramped up until it reaches 2 milliampere (mA), and subjects will be stimulated for 20 min.

Also known as: Active

Active tDCS + Diet

Hypocaloric diet BEHAVIORAL

A hypocaloric dietary prescription and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment.

Also known as: Diet

Active tDCS + Diet; Sham tDCS + Diet

Sham tDCS DEVICE

The electrodes will be placed at the same positions as in active stimulation; however, the device will be turned off after 30 s of stimulation.

Also known as: Placebo

Sham tDCS + Diet

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women of childbearing potential who are using medically approved birth control methods (eg hormonal contraceptives, intra uterine device (IUDs), barrier contraception) and who agree to use the same methods of contraception throughout the course of the study.
• BMI 25 ≥ 35 Kg/m2 at screening
• Stable weight for at least 12 weeks prior to screening
• Able and willing to provide written informed consent and to comply with the requirements of the study protocol

You may not qualify if:

• Pregnant or intend to become pregnant during the study period or who are currently breastfeeding.
• Women in perimenopause / menopause, or postmenopausal status, or who have had early menopause (under 40 years) or have had a hysterectomy or oophorectomy.
• Diagnosis or history of diabetes Mellitus type 1, diabetes resulting from pancreatic injury or secondary forms of diabetes, such as, for example, Cushing's syndrome and acromegaly.
• Metabolic and acute complications of diabetes such as ketoacidosis and hyperosmolar coma within the past six months.
• Gastrointestinal disease clinically symptomatic including, among others, inflammatory bowel disease and/or malabsorption diseases.
• Have received nutritional counseling in the last six months by a nutritionist.
• History of severe depression or other serious psychiatric comorbidities.
• History of gastric bypass, antrectomy or small bowel resection.
• History of chronic pancreatitis or idiopathic acute pancreatitis
• Myocardial infarction (MI), coronary arteries bypass surgery, post-transplant cardiomyopathy or stroke in the last 6 months
• Any abnormality in clinical laboratory tests which might prevent safe participation in the study
• Diagnosed and / or treated tumor (except basal cell skin cancer, carcinoma in situ of the cervix or prostate cancer in situ) in the last five years.
• History of known hemoglobinopathy and chronic anemia.
• Donation of one unit (500 ml) of blood or more, significant blood loss equivalent to at least one unit of blood within the last 2 weeks or blood transfusion in the past 8 weeks.
• Treatment with any oral antidiabetic drugs and / or herbal preparations or medications that do not require a prescription and can affect glycemic control within 12 weeks prior to screening.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (21)

• Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.

  PMID: 22029981 BACKGROUND

• Schur EA, Kleinhans NM, Goldberg J, Buchwald D, Schwartz MW, Maravilla K. Activation in brain energy regulation and reward centers by food cues varies with choice of visual stimulus. Int J Obes (Lond). 2009 Jun;33(6):653-61. doi: 10.1038/ijo.2009.56. Epub 2009 Apr 14.

  PMID: 19365394 BACKGROUND

• Boggio PS, Zaghi S, Villani AB, Fecteau S, Pascual-Leone A, Fregni F. Modulation of risk-taking in marijuana users by transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC). Drug Alcohol Depend. 2010 Dec 1;112(3):220-5. doi: 10.1016/j.drugalcdep.2010.06.019. Epub 2010 Aug 21.

  PMID: 20729009 BACKGROUND

• Fregni F, Orsati F, Pedrosa W, Fecteau S, Tome FA, Nitsche MA, Mecca T, Macedo EC, Pascual-Leone A, Boggio PS. Transcranial direct current stimulation of the prefrontal cortex modulates the desire for specific foods. Appetite. 2008 Jul;51(1):34-41. doi: 10.1016/j.appet.2007.09.016. Epub 2007 Dec 23.

  PMID: 18243412 BACKGROUND

• Goldman RL, Borckardt JJ, Frohman HA, O'Neil PM, Madan A, Campbell LK, Budak A, George MS. Prefrontal cortex transcranial direct current stimulation (tDCS) temporarily reduces food cravings and increases the self-reported ability to resist food in adults with frequent food craving. Appetite. 2011 Jun;56(3):741-6. doi: 10.1016/j.appet.2011.02.013. Epub 2011 Feb 23.

  PMID: 21352881 BACKGROUND

• Montenegro RA, Okano AH, Cunha FA, Gurgel JL, Fontes EB, Farinatti PT. Prefrontal cortex transcranial direct current stimulation associated with aerobic exercise change aspects of appetite sensation in overweight adults. Appetite. 2012 Feb;58(1):333-8. doi: 10.1016/j.appet.2011.11.008. Epub 2011 Nov 12.

  PMID: 22108669 BACKGROUND

• Kekic M, McClelland J, Campbell I, Nestler S, Rubia K, David AS, Schmidt U. The effects of prefrontal cortex transcranial direct current stimulation (tDCS) on food craving and temporal discounting in women with frequent food cravings. Appetite. 2014 Jul;78:55-62. doi: 10.1016/j.appet.2014.03.010. Epub 2014 Mar 20.

  PMID: 24656950 BACKGROUND

• Lapenta OM, Sierve KD, de Macedo EC, Fregni F, Boggio PS. Transcranial direct current stimulation modulates ERP-indexed inhibitory control and reduces food consumption. Appetite. 2014 Dec;83:42-48. doi: 10.1016/j.appet.2014.08.005. Epub 2014 Aug 13.

  PMID: 25128836 BACKGROUND

• Jauch-Chara K, Kistenmacher A, Herzog N, Schwarz M, Schweiger U, Oltmanns KM. Repetitive electric brain stimulation reduces food intake in humans. Am J Clin Nutr. 2014 Oct;100(4):1003-9. doi: 10.3945/ajcn.113.075481. Epub 2014 Aug 6.

  PMID: 25099550 BACKGROUND

• Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.

  PMID: 17452283 BACKGROUND

• Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.

  PMID: 21320389 BACKGROUND

• Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.

  PMID: 22037126 BACKGROUND

• Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.

  PMID: 16427357 BACKGROUND

• Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

  PMID: 10990547 BACKGROUND

• Bertolazi AN, Fagondes SC, Hoff LS, Pedro VD, Menna Barreto SS, Johns MW. Portuguese-language version of the Epworth sleepiness scale: validation for use in Brazil. J Bras Pneumol. 2009 Sep;35(9):877-83. doi: 10.1590/s1806-37132009000900009. English, Portuguese.

  PMID: 19820814 BACKGROUND

• Graff SK, Alves BC, Toscani MK, Spritzer PM. Benefits of pedometer-measured habitual physical activity in healthy women. Appl Physiol Nutr Metab. 2012 Feb;37(1):149-56. doi: 10.1139/h11-145. Epub 2012 Jan 30.

  PMID: 22288927 BACKGROUND

• Gorenstein C, Andrade L. Validation of a Portuguese version of the Beck Depression Inventory and the State-Trait Anxiety Inventory in Brazilian subjects. Braz J Med Biol Res. 1996 Apr;29(4):453-7.

  PMID: 8736107 BACKGROUND

• Juraschek SP, Steffes MW, Miller ER 3rd, Selvin E. Alternative markers of hyperglycemia and risk of diabetes. Diabetes Care. 2012 Nov;35(11):2265-70. doi: 10.2337/dc12-0787. Epub 2012 Aug 8.

  PMID: 22875225 BACKGROUND

• Liebetanz D, Koch R, Mayenfels S, Konig F, Paulus W, Nitsche MA. Safety limits of cathodal transcranial direct current stimulation in rats. Clin Neurophysiol. 2009 Jun;120(6):1161-7. doi: 10.1016/j.clinph.2009.01.022. Epub 2009 Apr 28.

  PMID: 19403329 BACKGROUND

• de Araujo C, Fitz RC, Natividade GR, Osorio AF, Merello PN, Schoffel AC, Brietzke E, Azevedo MJ, Schestatsky P, Gerchman F. The effect of transcranial direct current stimulation along with a hypocaloric diet on weight loss in excessive weight people: A pilot randomized clinical trial. Clin Nutr ESPEN. 2020 Dec;40:68-76. doi: 10.1016/j.clnesp.2020.10.005. Epub 2020 Oct 22.

  PMID: 33183574 DERIVED

• Araujo C, Fitz RC, Nogara DA, Schestatsky P, Gerchman F. 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. Trials. 2018 Jul 16;19(1):386. doi: 10.1186/s13063-018-2776-3.

  PMID: 30012180 DERIVED

MeSH Terms

Conditions

Prediabetic State; Obesity; Weight Loss; Diabetes Mellitus; Overweight

Interventions

Diet

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Fernando Gerchman, MD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Gerchman, MD

CONTACT

+55 51 33598127; fgerchman@gmail.com

Carina de Araujo, RND

CONTACT

+55 51 33598127; carinanutri@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: February 17, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 8, 2017

Record last verified: 2017-08

Locations

BR (1)