Sensory ScienceSweedNCT02112292
The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking
A study testing tetrahydrocannabinol and cannabidiol in people with Sensory Science, run by Wageningen University at 1 site in Netherlands.
Trial summary
The endocannabinoid (eCB) system, a neurochemical signalling system consisting of CB-receptors and their endogenous ligands, 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sensory Science
- What is being tested?
- tetrahydrocannabinol and cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to 16 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 18.5 - 25 kg/m2
- Incidental cannabis use for at least one year, at least four times per year, but less than once a week.
- Dutch-speaking
- Willing to comply with the study procedures
- Having given written informed consent
Who cannot join
- Not meeting the inclusion criteria
- Restraint eating (men: score > 2.90)
- Lack of appetite
- Having difficulties with swallowing/eating
- Usage of an energy restricted diet during the last two months
- Weight loss or weight gain of 5kg or more during the last two months
Show all 16Show fewer
- Stomach or bowel disease
- Diabetes, thyroid disease, other endocrine disorders
- Use of daily medication except paracetamol
- Having taste or smell disorders (self-report)
- Being allergic/intolerant for products under study
- Previously experienced an adverse reaction to cannabinoids (e.g. anxiety, paranoia, nausea)
- Having (had) a schizophrenia or other psychotic illness
- Having a family history of schizophrenia or other psychotic illness
- Working at the Division of Human Nutrition (WUR)
- Current participation in other research from the Division of Human Nutrition (WUR)
Trial locations and contacts
1 site in 1 country.
About this study
The endocannabinoid (eCB) system, a neurochemical signalling system consisting of CB-receptors and their endogenous ligands, 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 sweet taste intensity increases and that sweet taste is experienced as more pleasant.
- Conditions
- Sensory Science
- Being tested
- tetrahydrocannabinol, cannabidiol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetrahydrocannabinolDrug
Also called delta-9-tetrahydrocannabinol, THC
cannabidiolDrug
Also called CBD
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| T-C-P | Experimental | Order of administrations: tetrahydrocannabinol - cannabidiol - placebo Receives: Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo |
| T-P-C | Experimental | Order of administrations: tetrahydrocannabinol - placebo - cannabidiol Receives: Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo |
| C - T - P | Experimental | Order of administrations: cannabidiol - tetrahydrocannabinol - placebo Receives: Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo |
| C - P - T | Experimental | Order of administrations: cannabidiol - placebo - tetrahydrocannabinol Receives: Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo |
| P - T - C | Experimental | Order of administrations: placebo - tetrahydrocannabinol - cannabidiol Receives: Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo |
| P - C - T | Experimental | Order of administrations: placebo - cannabidiol - tetrahydrocannabinol Receives: Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between sweet taste intensity and liking
The main study parameter is the relation between sucrose intensity scaling (psychophysics) and liking (psychohedonics) of drinks with the different sucrose concentrations. These scores will be assessed after six participants and at end of the study.
Measured: 15 minutes after intervention
Secondary outcomes (5)
Ranking order of pleasantness of different drinks with different levels of sucrose.
Ranking order will be assessed after 6 participants and at end of the study
Measured: 25 minutes after intervention
Preferences for different kinds of foods
Preference for foods high in one of three macronutrients (carbohydrate, protein, fat) or low in energy
Measured: 45 minutes after intervention (15 minutes after top-up dose)
Ad libitum intake
Ad libitum intake of a chocolate-based drink
Measured: 35 minutes after intervention (5 minutes after top-up dose)
Change of plasma levels of (endo-)cannabinoids and satiety hormones
Measured: One hour after intervention
Polymorphisms
The genetic determination of the enzymes responsible for the metabolism of THC and CBD.
Measured: At test session, i.e., 2 weeks before first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion16 Apr 2015
- Study completion16 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory ScienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne EM de Bruijn, MSc, Principal investigator, Wageningen UniversityGerry Jager, Dr., Study chair, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112292
- Sponsor's protocol ID
- NL44758.081.13
- Other IDs
- 2013-002555-14
- Acronym
- Sweed
- Status last verified
- May 2017
- First submitted
- 25 Mar 2014
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking
- ClinicalTrials.gov ID
- NCT02112292
- Acronym / sponsor ID
- Sweed / NL44758.081.13
- Conditions
- Sensory Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 16 Apr 2015 (actual)
- Study completion
- 16 Apr 2015 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The endocannabinoid (eCB) system, a neurochemical signalling system consisting of CB-receptors and their endogenous ligands, 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 sweet taste intensity increases and that sweet taste is experienced as more pleasant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| T-C-P | Experimental | Drug: tetrahydrocannabinol, Drug: cannabidiol, Drug: PlaceboOrder of administrations: tetrahydrocannabinol - cannabidiol - placebo |
| T-P-C | Experimental | Drug: tetrahydrocannabinol, Drug: cannabidiol, Drug: PlaceboOrder of administrations: tetrahydrocannabinol - placebo - cannabidiol |
| C - T - P | Experimental | Drug: tetrahydrocannabinol, Drug: cannabidiol, Drug: PlaceboOrder of administrations: cannabidiol - tetrahydrocannabinol - placebo |
| C - P - T | Experimental | Drug: tetrahydrocannabinol, Drug: cannabidiol, Drug: PlaceboOrder of administrations: cannabidiol - placebo - tetrahydrocannabinol |
| P - T - C | Experimental | Drug: tetrahydrocannabinol, Drug: cannabidiol, Drug: PlaceboOrder of administrations: placebo - tetrahydrocannabinol - cannabidiol |
| P - C - T | Experimental | Drug: tetrahydrocannabinol, Drug: cannabidiol, Drug: PlaceboOrder of administrations: placebo - cannabidiol - tetrahydrocannabinol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI: 18.5 - 25 kg/m2
- Incidental cannabis use for at least one year, at least four times per year, but less than once a week.
- Dutch-speaking
- Willing to comply with the study procedures
- Having given written informed consent
Key exclusion criteria (16 listed)
- Not meeting the inclusion criteria
- Restraint eating (men: score > 2.90)
- Lack of appetite
- Having difficulties with swallowing/eating
- Usage of an energy restricted diet during the last two months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tetrahydrocannabinolAlso: delta-9-tetrahydrocannabinol, THC | Drug | C - P - T, C - T - P, P - C - T, P - T - C, T-C-P, T-P-C |
| cannabidiolAlso: CBD | Drug | C - P - T, C - T - P, P - C - T, P - T - C, T-C-P, T-P-C |
| Placebo | Drug | C - P - T, C - T - P, P - C - T, P - T - C, T-C-P, T-P-C |
Primary outcome
Relation between sweet taste intensity and liking
Time frame: 15 minutes after intervention
The main study parameter is the relation between sucrose intensity scaling (psychophysics) and liking (psychohedonics) of drinks with the different sucrose concentrations. These scores will be assessed after six participants and at end of the study.
5 secondary outcomes
Ranking order of pleasantness of different drinks with different levels of sucrose.
Time frame: 25 minutes after intervention
Preferences for different kinds of foods
Time frame: 45 minutes after intervention (15 minutes after top-up dose)
Ad libitum intake
Time frame: 35 minutes after intervention (5 minutes after top-up dose)
Change of plasma levels of (endo-)cannabinoids and satiety hormones
Time frame: One hour after intervention
Polymorphisms
Time frame: At test session, i.e., 2 weeks before first intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
Related trials for Sensory Science
Recruiting
Neural Basis of Sensory Learning: Brain Regions
Basic Science
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne EM de Bruijn, MSc principal investigator
Wageningen University
Gerry Jager, Dr. study chair
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tetrahydrocannabinol and cannabidiol in people with Sensory Science, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between sweet taste intensity and liking (time frame: 15 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.