The primary objective of this study is to assess if cannabinoids modulate sweet taste intensity and liking.
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the sucrose intensity scaling (psychophysics) and
liking (psychohedonics) of the milkshakes with the different sucrose
concentrations.
Secondary outcome
The first secondary objective it to assess if cannabinoids influence the
preferred sucrose concentration and the total amount of milkshake consumed in
the preference task.
The second secondary objective is to see if the blood levels of
endocannabinoids, leptin, ghrelin and insulin change during the course of the
session and if there are differences between sessions.
The third secondary objective is to follow plasma levels of THC or CBD and
their active metabolites.
The fourth secondary study objective is changes in liking of food products and
in food choice in the food preference task. This also includes reaction time
for the food choice questions.
The fifth and final secondary study objective is the genetic determination of
the enzymes responsible for the metabolism of THC and CBD.
Background summary
The endocannabinoid (eCB) system has been found to be involved in food intake
of sweet and palatable foods. Activation of the eCB system increases food
intake and vice versa. The mechanism behind this effect is still unknown and
the current study aims at clarifying why sweet food intake increases. It is
hypothesized that activation of the eCB increases sweet taste intensity and
that sweet taste is experienced as more pleasant.
Study objective
The primary objective of this study is to assess if cannabinoids modulate sweet
taste intensity and liking.
Study design
Double-blind, placebo controlled human intervention study with a
within-subjects design. To assess sweet taste intensity and liking, milkshakes
with different levels of sucrose will be used.
Intervention
Each participant receives Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) or
placebo in three separate sessions that will be at least two weeks apart.
Study burden and risks
The study will consist of a 30 minute information session, a 90 minute practice
session and three test sessions of approximately 150 minutes per session on
separate days. During the last hour of each test session, participant are free
to do what they want to do, as long as they stay in the room were the test
session takes place. The study is non-therapeutic for participants.
Participants will receive a low dosage of THC during one session and a dosage
of the non-psychoactive substance CBD during another session. All participants
have experience with cannabis and have never experienced an adverse reaction.
The risk of an adverse reaction is therefore low. A medical doctor will be
available and within a 5-minutes distance from the participants.
Bomenweg 2
Wageningen 6703 HD
NL
Bomenweg 2
Wageningen 6703 HD
NL
Listed location countries
Age
Inclusion criteria
Male
Healthy
Incidental user of Cannabis
Exclusion criteria
Previously experienced an adverse reaction to cannabinoids (e.g. anxiety, paranoia, naussea, vomiting)
Having a family history of schizophrenia or other psychotic ilness
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 |
|---|---|
| EudraCT | EUCTR2013-002555-14-NL |
| CCMO | NL44758.081.13 |