Trial document





This trial has been registered retrospectively.
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  DRKS00005811

Trial Description

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Title

The influence of tDCS on food intake.

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Trial Acronym

tofi

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study will determine whether electrical stimulation of a brain area called the dorsolateral prefrontal cortex (DLPFC), affects how much food a person eats.. We will test 14 normal-weight healthy men aged 20 to 30 years.
Participants will be tested in the Department of Psychiatry and Psychotherapy, University of Luebeck, during 8 days of daily tDCS (transcranial direct current stimulation) or sham stimulation. The experiment will start at 15:30 h with the placement of electrodes. Thereafter, 20 minutes of tDCS/sham stimulation will be applied. On day 1 and day 8 of both tDCS and sham condition, participants will be allowed to eat ad libitum from a buffet. Before the tDCS and/or sham stimulation and before food consumption participants will moreover rate their hunger on a ten-point rating scale as well as their appetite for foods as well as specifically for sweet and savory food on a 100-mm visual analog scale.

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Brief Summary in Scientific Language

In a single-blinded, placebo-controlled, randomized cross-over within-subject comparison, 14 healthy young male normalweight men with body mass index of 20-25 kg/m2 will be examined during 8 days of daily tDCS or sham stimulation. Against the background thatthe dorso-lateral prefrontal cortex (DLPFC) plays an important role in appetite and food intake regulation we hypothesize that repetitive application of anodal direct currents to the prefrontal cortical brain area reduces food intake in humans. To test this hypothesis, we will assess self-reported appetite and hunger scores as well as food intake behavior from a standardized ad libitum buffet after one week of daily anodal tDCS stimulation of the right prefrontal cerebral cortex.

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Organizational Data

  •   DRKS00005811
  •   2014/02/25
  •   [---]*
  •   yes
  •   Approved
  •   11-152, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   Food intake behavior
    Appetite
    Hunger
    healthy subjects
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Interventions/Observational Groups

  •   daily 20 minutes anodal application of tDCS (transcranial direct current stimulation)(1 mA, fade in/out 8 s) over 8 days
  •   sham stimulation
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

1. Caloric consumption on day 1 and 8 determined after weighting of food before and after food intake by using of table of product nutritional value
2. Appetite on day 1 and 8 rated before tDCS/sham stimulation and before food consumption on a VAS
3. Hunger on day 1 and 8 rated before tDCS/sham stimulation and before food consumption on a 10-point scale

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Secondary Outcome

n/a

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/12/15
  •   14
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   20   Years
  •   30   Years
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Additional Inclusion Criteria

healthy, normal-weight men

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Exclusion Criteria

any kind of medication, acute and chronic medical diseases, diabetes mellitus in 1-degree family members, alcohol or drug abuse, smoking, shift work, and competitive sports

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Addresses

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    • Department of Psychiatry and PsychotherapyUniversity of Luebeck23538 LuebeckGermanyPhone: 0049-(0)451-5006342
    • Ms.  PD Dr. med.  Kamila  Jauch-Chara 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Department of Psychiatry and PsychotherapyUniversity of Luebeck23538 LuebeckGermanyPhone: 0049-(0)451-5006342
    • Ms.  PD Dr. med.  Kamila  Jauch-Chara 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Department of Psychiatry and PsychotherapyUniversity of Luebeck23538 LuebeckGermanyPhone: 0049-(0)451-5006342
    • Ms.  PD Dr. med.  Kamila  Jauch-Chara 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/06/15
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.