To determine the effects of context (food context vs. e-cigarette context), odor category (sweet vs. savory) and user group (smokers vs. non-smokers) on reward-related brain activation.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hersenactivatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the brain response to odors in reward-related
brain areas, measured with fMRI.
Secondary outcome
Secondary study parameters are quantitative ratings for odor liking, intensity
of odor sweetness, intensity of odor savoriness, and willingness to try the
e-cigarette/food product obtained using a continuous 100-unit visual analogue
scale (VAS). Other secundary study parameters are questionnaires outcomes about
reward sensitivity, impulsivity, sensitivity to food cues, smoking and vaping
characteristics, and other parameters such as age, gender, history of
e-cigarette use, and intention to quit smoking.
Background summary
Electronic cigarettes (e-cigarettes) were introduced a few years ago. Whereas
smoking burns Tobacco, the use of an e-cigarette (vaping) only heats an
e-liquid. E-liquids are available in thousands of different flavors, which
contribute to product attractiveness. The availability of e-liquids in various
flavors is positive as well as negative. On one hand, attractive e-liquid
flavors may help currently addicted smokers to quit smoing and switch to
e-cigarettes, a product that is potentially less harmful. On the other hand,
research showed that e-cigarette use is increasing among middle and high school
students, and flavors are identified as one of the top reasons for use.
Worldwide, governments have raised concerns about e-cigarette use among
adolescents, which is why more knowledge about e-liquid flavors is necessary.
On behalf of the Dutch Ministry of Health, Welfare, and Sports, Wageningen
University and RIVM collaborate in order to investigate e-liquid flavors in
different user groups. Investigating brain processes provides more insight in
the role of different odors/flavors in e-cigarette use. As the role of
odors/flavors in eating behavior is well known, we aim to investigate it this
is comparable to the role of odors/flavors in e-cigarette use. Focusing on
neural processes involved will allow us to better understand why people like
(flavored) e-cigarettes, how liking of e-cigarettes may differ from liking of
food, and if this differs between user groups (e.g. smokers/non-smokers).
Results of our previous sensory study (Smell-e studie, METC protocol
NL65748.081.18, Dutch Trial Register Trial NL7319 [NTR7535]) showed that the
correlation coefficient between smelling and vaping for hedonic assessment of
e-liquid flavors is strong, which justifies the use of orthonasal smelling in
the current BrainAppeal study.
Study objective
To determine the effects of context (food context vs. e-cigarette context),
odor category (sweet vs. savory) and user group (smokers vs. non-smokers) on
reward-related brain activation.
Study design
This study has a 2x2x2 mixed design in which brain responses to sweet and
savory odors will be measured in an e-cigarette and food context in smoking and
non-smoking subjects.
Intervention
During fMRI, sweet and savory odors will be presented using an olfactometer.
Accompanying visual cues will be used to create an e-cigarette and food
context. Ratings for odor liking, intensity of odor sweetness, intensity of
odor savoriness, and willingness to try the e-cigarette/food product will be
collected on a 100-unit Visual Analogue Scale.
Study burden and risks
The study is non-therapeutic to the subjects; no immediate benefits are
expected from participation in this study. The risk associated with
participation is negligible. In terms of time, the subject*s burden is as
follows: both the information meeting and the screening/training visit will
take approximately 30 minutes, and the experimental test visit will take
approximately 1 hour and 10 minutes, of which subjects spend less than an hour
in the scanner. To undergo an fMRI scan involves: exposure to loud noise, a
moderate amount of physical restraint, as well as exposure to a strong magnetic
field (3 Tesla) of which the subject is unaware, that is, the subject does not
*feel* being in a magnetic field. During the scanning session, subjects will
receive olfactory stimuli, embedded in a constant stream of odorless air which
is heated to body temperature and humidified to 80% relative humidity.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
- Be susceptible to e-cigarette use (for definition, see *C1 Research Protocol*)
- Be smoker or non-smoker (for definition, see *C1 Research Protocol*)
- Normal olfactory function according to the Sniffin* Sticks identification
test (>=12 correct answers out of 16)
- Good proficiency of the Dutch and/or English language
- Right-handed
- Aged 18-55 years at the time of inclusion
- Normal BMI (between 18.5-25 kg/m2)
- Healthy as defined by the *F1_1 General screening questionnaire*
- Willing to be informed about incidental findings of pathology and approving
of reporting this to their general physician
- Willing to refrain from using drugs other than tobacco and alcohol for one
week before the test session
Exclusion criteria
- Dislike the odors under investigation
- Allergic or hyper sensitive reaction to yoghurt
- The use of prescribed or non-prescribed medication in the month prior to the
test session, other than occasional use of pain medication (such as paracetamol
and NSAID*s) or oral contraceptives
- Have a history of drug or alcohol dependence
- Have a psychiatric, neurological, or eating disorder or chronic medical
condition
- Be employed by the Division of Human Nutrition and Health of Wageningen
University or doing an MSc internship/writing a thesis at the Sensory Science
and Eating Behavior chair group within the Division of Human Nutrition and
Health of Wageningen University
- Participation in another medical-scientific study (except for EetMeetWeet)
- Claustrophobic (self-report)
- Having a contra-indication to MRI scanning, including but not limited to
non-removable piercings, a pacemaker, or ferromagnetic implants
- Limited sight that is not corrected with contact lenses or cannot be
corrected with our MRI safe glasses (maximum strength is +6 and -6)
- For women: lactating, being pregnant, or using a IUD as anti-conceptive (with
exception of the Mirena IUD).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70699.081.19 |