The objective of the study is to determine the difference in brain responses after consumption of processed and unprocessed food between healthy lean subjects with a *normal* eating pattern with that of Binge Eating Disorder (BED) patients, who are…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will compare the response of the brain to a commercially available candy bar
(processed) with a mix of peanuts and dried dates (unprocessed) matched for
total calories, carbohydrates, fat, and protein content. Differences in brain
responses between processed and unprocessed food as measured with functional
Magnetic resonance imaging (fMRI) will be the main study parameters.
Secondary outcome
Visual Analogue Scale (VAS) scores for the level of hunger, thirst and satiety
before and after ingestion of the food stimuli.
Questionnaire scores for normal eating habits
Questionnaire scores for normal physical activity habits
Weight
Height
Fat percentage
BMI
Background summary
Processed foods are foods that are produced industrially from substances
derived from foods, often with many additives, but with little *whole original
food* ingredients. These types of food tend to be high in calories, (saturated)
fat, sugar, and salt, while being nutrient-poor compared to unprocessed foods.
Not surprisingly, increased consumption of processed foods raises our daily
calorie intake, as in addition to the higher calorie content, processed foods
are also associated with a relatively short period of satiation, this is seen
as an important cause of overweight an obesity. Even though most people are
aware that processed foods are unhealthy, over 50% of our modern diet consists
of these foods. The importance of the (subconscious) regulatory role of the
brain in directing this eating behavior is increasingly recognized.
Study objective
The objective of the study is to determine the difference in brain responses
after consumption of processed and unprocessed food between healthy lean
subjects with a *normal* eating pattern with that of Binge Eating Disorder
(BED) patients, who are prone to overeating processed foods. We hypothesize
that the brain responds much stronger to processed food in BED, whereas much
smaller differences are expected after consuming unprocessed food.
Study design
Cross-over trail study design with two study visits with a patient and a
control group.
Study burden and risks
The study will consist of two visits to the LUMC (1-2 weeks between visits).
For each visit participants will undergo one MRI scan, the duration of this
visit will be 1.5 hour excluding travel time (one hour for the MRI scan plus
instructions and preparations and questionnaires). The potential risks are
limited. The risks of MRI are minimal (risk of everyday life), because there
are no consequences to the health of the participant. The potential risk of the
food intervention are limited as these are commercially available products and
participants with food allergies will not be included in the study. The
questionnaires used during the study are also of a low burden nature.
Albinusdreef 2
Leiden 2300RC
NL
Albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
Inclusion criteria
Control subjects:
* Aged >18
* BMI >18,5 and <25
BED patients:
* Aged 18>
* A primary diagnosis of BED according to DSM*IV criteria or subthreshold BED
(an average of one binge eating episode a week)
* BMI >30
Exclusion criteria
* Age <18
* BMI not >18,5 and <25 for control subjects and BMI <30 for BED patients
* Diabetes
* Any know food allergy or intolerance
* Renal or hepatic disease
* Use of medication known to affect glucose (for example prednisone) or lipid
metabolism
* A current history of self*induced vomiting, misuse of laxatives, diuretics,
enemas, diet pills or other weight controlling medications, fasting, or
excessive exercise within the last 24 weeks;
* A comorbid diagnosis of psychotic disorder, self*damaging behaviors or mental
deficiency
* Pregnancy
* Any contra-indication to MRI scanning
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74714.058.20 |
| Other | NL8851 Netherlands Trial Register |
| OMON | NL-OMON29485 |