- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02112292
The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking (Sweed)
May 22, 2017 updated by: Wageningen University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Wageningen, Gelderland, Netherlands, 6703 HD
- Wageningen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: T-C-P
Order of administrations: tetrahydrocannabinol - cannabidiol - placebo
|
Other Names:
Other Names:
|
Experimental: T-P-C
Order of administrations: tetrahydrocannabinol - placebo - cannabidiol
|
Other Names:
Other Names:
|
Experimental: C - T - P
Order of administrations: cannabidiol - tetrahydrocannabinol - placebo
|
Other Names:
Other Names:
|
Experimental: C - P - T
Order of administrations: cannabidiol - placebo - tetrahydrocannabinol
|
Other Names:
Other Names:
|
Experimental: P - T - C
Order of administrations: placebo - tetrahydrocannabinol - cannabidiol
|
Other Names:
Other Names:
|
Experimental: P - C - T
Order of administrations: placebo - cannabidiol - tetrahydrocannabinol
|
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ranking order of pleasantness of different drinks with different levels of sucrose.
Time Frame: 25 minutes after intervention
|
Ranking order will be assessed after 6 participants and at end of the study
|
25 minutes after intervention
|
Preferences for different kinds of foods
Time Frame: 45 minutes after intervention (15 minutes after top-up dose)
|
Preference for foods high in one of three macronutrients (carbohydrate, protein, fat) or low in energy
|
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)
|
Ad libitum intake of a chocolate-based drink
|
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
|
One hour after intervention
|
|
Polymorphisms
Time Frame: At test session, i.e., 2 weeks before first intervention
|
The genetic determination of the enzymes responsible for the metabolism of THC and CBD.
|
At test session, i.e., 2 weeks before first intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptives
Time Frame: At inclusion of participants
|
General subject characteristics, e.g age, restrained eating score and other lifestyle and medical parameters
|
At inclusion of participants
|
Appetite ratings
Time Frame: During each test session
|
During each test session, appetite ratings will be assessed at several time points
|
During each test session
|
Subjective feelings
Time Frame: During each test session
|
During each test sessions, participants will rate the effects of the intervention.
|
During each test session
|
Perception
Time Frame: 20 minutes after intervention
|
Participants will rate the intensity of different shades of grey.
|
20 minutes after intervention
|
Sweet taste intensity
Time Frame: 15 minutes after intervention
|
Sucrose intensity of drinks (psychophysics) of drinks with different sucrose concentrations.
This will be assessed after six participants and at end of the study.
|
15 minutes after intervention
|
Liking of sweet taste
Time Frame: 15 minutes after intervention
|
Liking (psychohedonics) of drinks with the different sucrose concentrations.
This will be assessed after six participants and at end of the study.
|
15 minutes after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suzanne EM de Bruijn, MSc, Wageningen University
- Study Chair: Gerry Jager, Dr., Wageningen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
April 16, 2015
Study Completion (Actual)
April 16, 2015
Study Registration Dates
First Submitted
March 25, 2014
First Submitted That Met QC Criteria
April 9, 2014
First Posted (Estimate)
April 11, 2014
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
May 22, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Anticonvulsants
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
- Cannabidiol
Other Study ID Numbers
- NL44758.081.13
- 2013-002555-14 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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