Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
120

Inclusion Criterias

Body Mass Index (BMI) between 25 and 40 kg/m2
Healthy male and female subjects
Fulfilment of the criteria for blood donors according to the "Richtlinien zur Gewinnung von Blut und Blutbestandteilen und zur Anwendung von Blutprodukten", in particular Hb ≥ 135 g/l (8,37 mmol/l; Bundesärztekammer 2010)
...
Body Mass Index (BMI) between 25 and 40 kg/m2
Healthy male and female subjects
Fulfilment of the criteria for blood donors according to the "Richtlinien zur Gewinnung von Blut und Blutbestandteilen und zur Anwendung von Blutprodukten", in particular Hb ≥ 135 g/l (8,37 mmol/l; Bundesärztekammer 2010)
Informed consent to study protocol
Willingness to be informed about chance findings of pathology and approval of the disclosure of this information to the general physician (see Informed Consent)
Age 18-65 years at start of the study

Exclusion Criterias

Metal prosthesis
Intraport, etc.
Artificial heart valve
...
Metal prosthesis
Intraport, etc.
Artificial heart valve
Operation less than three month ago
Metallic implants (screws, plates from operations, etc.)
In field strengths of over 1.0 T also: tattoos, eye lid-shadow
Claustrophobia
Participation in other studies with blood withdrawals or blood donation in previous and subsequent 2 months
Acute illness or infection during the last 4 weeks
Heart pace-maker
Neurological disorder or injury
Acupuncture needles
Limited temperature perception and/or increased sensitivity to warming of the body
Current weight loss regimens
Intake of antidepressants / antipsychotics
Moderate or severe head injury
Severe psychotic illness
Lack of ability to give informed consent
Pathological hearing ability or an increased sensitivity to loud noises
Simultaneous participation in other studies
Insulin pump
Non-removable dental braces
Metal splinters / grenade fragments

Summary

Conditions
  • Eating Behaviour
  • Obesity
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Primary objective: We want to investigate whether the training-induced up-regulation of the dorsal prefrontal cortex inhibits eating behaviour. Study design: A parallel design. Half of the participants will learn to up-regulate activity of the dorsolateral prefrontal cortex (dlPFC), while the other ...

Primary objective: We want to investigate whether the training-induced up-regulation of the dorsal prefrontal cortex inhibits eating behaviour. Study design: A parallel design. Half of the participants will learn to up-regulate activity of the dorsolateral prefrontal cortex (dlPFC), while the other participants will participate in sham-training sessions. Adherence to experimental conditions will be assigned randomly, based on the participants' enrolment in the study, balanced by gender and binge eating classification. Study population: 50 overweight and obese (BMI 25-40 kg/m2), but otherwise healthy individuals, 18-65 years old. Intervention: All participants will participate in a screening day, followed by one neurofeedback session day and a follow-up day. During the neurofeedback session, participants will undergo a 45 min real-time-fMRI-brain-computer-interface scan in order to learn to up-regulate dlPFC activation. Main study parameters/endpoints: The ability to up-regulate dlPFC activity. Respective effects on eating behaviour. Nature and extent of the burden and risks associated with participation: Participants will be scanned once (fMRI). Functional MRI is a safe and non-invasive technique.

Inclusion Criterias

Body Mass Index (BMI) between 25 and 40 kg/m2
Healthy male and female subjects
Fulfilment of the criteria for blood donors according to the "Richtlinien zur Gewinnung von Blut und Blutbestandteilen und zur Anwendung von Blutprodukten", in particular Hb ≥ 135 g/l (8,37 mmol/l; Bundesärztekammer 2010)
...
Body Mass Index (BMI) between 25 and 40 kg/m2
Healthy male and female subjects
Fulfilment of the criteria for blood donors according to the "Richtlinien zur Gewinnung von Blut und Blutbestandteilen und zur Anwendung von Blutprodukten", in particular Hb ≥ 135 g/l (8,37 mmol/l; Bundesärztekammer 2010)
Informed consent to study protocol
Willingness to be informed about chance findings of pathology and approval of the disclosure of this information to the general physician (see Informed Consent)
Age 18-65 years at start of the study

Exclusion Criterias

Metal prosthesis
Intraport, etc.
Artificial heart valve
...
Metal prosthesis
Intraport, etc.
Artificial heart valve
Operation less than three month ago
Metallic implants (screws, plates from operations, etc.)
In field strengths of over 1.0 T also: tattoos, eye lid-shadow
Claustrophobia
Participation in other studies with blood withdrawals or blood donation in previous and subsequent 2 months
Acute illness or infection during the last 4 weeks
Heart pace-maker
Neurological disorder or injury
Acupuncture needles
Limited temperature perception and/or increased sensitivity to warming of the body
Current weight loss regimens
Intake of antidepressants / antipsychotics
Moderate or severe head injury
Severe psychotic illness
Lack of ability to give informed consent
Pathological hearing ability or an increased sensitivity to loud noises
Simultaneous participation in other studies
Insulin pump
Non-removable dental braces
Metal splinters / grenade fragments

Locations

Tuebingen, 72076
Tuebingen, 72076

Tracking Information

NCT #
NCT02148770
Collaborators
Not Provided
Investigators
  • Principal Investigator: Manfred Hallschmid, PhD University Tuebingen
  • Manfred Hallschmid, PhD University Tuebingen