The Effect of Hypocaloric Diet Associated With tDCS on Weight Loss and Metabolic Profile
NCT ID: NCT02683902
Last Updated: 2017-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2016-03-31
2018-08-31
Brief Summary
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Detailed Description
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In the laboratory evaluation the biochemistry exams include an oral glucose tolerance test (OGGT 75g), a meal tolerance test (MTT), serum glucose, Cholesterol, HDL-cholesterol, triglycerides, glycated hemoglobin and glycated albumin. The resting metabolic rate will be determine by indirect calorimetry. Besides, a 100-mm visual-analog scales will be used to measure a self-reported ratings of appetite, hunger, satiety and food craving.
Patients will also be prescribed a low caloric diet and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment. Moreover, they will do one tDCS session a day (active or sham stimulation as previous randomization) for 5 consecutive days, during these four weeks of treatment (20 sessions).
Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation in which a small current is applied to the scalp. This technique uses a weak safety current of 2 milliampere (mA) for 20 minutes which may increase (anodal tDCS) or decrease (cathodal tDCS) cortical excitability.
During all of tDCS sessions, a film with images of food that usually elicit craving will be presented and after the end of each session, visual analog scales will be applied to assess hunger, satiety and presence of food craving. Finally, attention and mood scales will be applied periodically in addition to a questionnaire of adverse effects and use of tDCS.
At the end of the 4-week diet and tDCS, all patients will be submitted to the same clinical, laboratory, nutrition and feeding behavior exams applied at baseline.
Finally, participants should come in 3 and 6 months after the end of the protocol for reassessment weight, body composition by bioelectrical impedance and answer questionnaires.
An interim analysis will be performed when 12 patients will be included.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active tDCS + Diet
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.
Active tDCS
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.
Hypocaloric diet
A hypocaloric dietary prescription and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment.
Sham tDCS + Diet
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.
Hypocaloric diet
A hypocaloric dietary prescription and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment.
Sham tDCS
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.
Interventions
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Active tDCS
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.
Hypocaloric diet
A hypocaloric dietary prescription and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment.
Sham tDCS
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. BMI 25 ≥ 35 Kg/m2 at screening
3. Stable weight for at least 12 weeks prior to screening
4. Able and willing to provide written informed consent and to comply with the requirements of the study protocol
Exclusion Criteria
2. Women in perimenopause / menopause, or postmenopausal status, or who have had early menopause (under 40 years) or have had a hysterectomy or oophorectomy.
3. 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.
3.1. Metabolic and acute complications of diabetes such as ketoacidosis and hyperosmolar coma within the past six months.
4. Gastrointestinal disease clinically symptomatic including, among others, inflammatory bowel disease and/or malabsorption diseases.
5. Have received nutritional counseling in the last six months by a nutritionist.
6. History of severe depression or other serious psychiatric comorbidities.
7. History of gastric bypass, antrectomy or small bowel resection.
8. History of chronic pancreatitis or idiopathic acute pancreatitis
9. Myocardial infarction (MI), coronary arteries bypass surgery, post-transplant cardiomyopathy or stroke in the last 6 months
10. Any abnormality in clinical laboratory tests which might prevent safe participation in the study
11. 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.
12. History of known hemoglobinopathy and chronic anemia.
13. 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.
14. 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.
15. Chronic treatment with oral or parenteral corticosteroids (\> 7 consecutive days of treatment) within 4 weeks prior to screening.
16. Treatment with weight loss agents (e.g., orlistat, sibutramine, topiramate, bupropion) in the last 12 weeks prior to screening.
17. Treatment with mineral oil or fiber supplementation (e.g., Benefiber, Metamucil, among others).
18. Treatment with lipid-lowering drugs which have not been kept on a stable dose for the past 8 weeks before screening.
19. Treatment with thyroid replacement hormones which has not been kept on a stable dose for the past 12 weeks prior to screening.
20. Use of drugs under investigation within 30 days or 5 half-lives (whichever is longer) before screening unless the guidelines of local health authorities require a longer period.
21. Any of the following laboratory abnormalities identified in the screening by history and / or tests brought by the patient or that are part of this protocol, as described in section 4.3.4.6 of this project:
21.1. Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) \> 3 times the upper limit of normal 21.2. Glomerular filtration rate estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation ≤ 30 ml per min per 1,73 m2 21.3. Thyroid stimulating hormone (TSH) outside the normal range 21.4. Fasting triglycerides ≥ 400 mg / dL. 21.5. History of active substance abuse (including alcohol) within the past year
22. Any condition or concomitant medical disorder, not provided for in other items which in the opinion of the investigator, probably:
22.1. Interfere with the patient's ability to complete the entire study period or participate in all activities of the study 22.2. Require during the study, administration of a treatment that may affect the interpretation of efficacy and safety data
23. Patients potentially unreliable and those considered by the investigator as unsuitable for the study
20 Years
50 Years
ALL
Yes
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Fernando Gerchman, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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Fernando Gerchman, MD
Role: primary
Carina de Araujo, RND
Role: backup
References
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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.
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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.
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.
Other Identifiers
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15-0119
Identifier Type: -
Identifier Source: org_study_id