Trial document




drksid header

  DRKS00008882

Trial Description

start of 1:1-Block title

Title

Cerebral energy homeostasis and ingestion at neuronal activation

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ZEINA

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

We investiagete brain metabolism in overweight human and explore whether an influence affect the organism. We include 15 healthy obese subjects.
Each volunteer receive transcranial direct current stimulations of the brain and placebo-stimulations.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Brain energy metabolism and neuropsychological aspects of food intake control with respective behavioural correlates have been suggested to be closely interlinked. This project aims at testing the hypothesis that food intake behaviour, and particularly the preference for palatable high caloric (“comfort”) food by its incentive salience, is synchronized by the human brain in dependence of its current energy status.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008882
  •   2015/07/08
  •   [---]*
  •   yes
  •   Approved
  •   15-040, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1171-8336 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Basic research: food intake and brain metabolism
  •   healthy participants
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   brain-stimulation - direct current, transcraniell, anodal, 20min, 1,5mA, daily for one week
  •   placebo-stimulation
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Food intake measured by Buffet-Test on first day of stimulation and after a week stimulation

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

cerebral energy content measured by medical imaging on first day and on last day of stimulation. (before and after stimulation, respectively)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/07/15
  •   15
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   30   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

BMI: 25-40 kg/m²
Body fat percentage: >25 %

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Smoker
disturbe eating behaviour (tested with FEV)
acute or chronic disease
explicit: diagnosis of migraine or other headache diseases
permanent medication
shiftworker
circadian dysrhythmia
competitive sportsman
diabetics
mental illness

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Sektion für Psychoneurobiologie
    • Ms.  Prof. Dr. med.  Kerstin M.  Oltmanns 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Sektion für Psychoneurobiologie
    • Ms.  Prof. Dr. med.  Kerstin M.  Oltmanns 
    • Razeburger Allee 160
    • 23562  Lübeck
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Sektion für Psychoneurobiologie
    • Mr.  Dr. med.  Georg  Gohla 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.