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The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking (Sweed)

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ClinicalTrials.gov Identifier: NCT02112292
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Wageningen University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sensory Science Drug: tetrahydrocannabinol Drug: cannabidiol Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking
Study Start Date : April 2014
Actual Primary Completion Date : April 16, 2015
Actual Study Completion Date : April 16, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: T-C-P
Order of administrations: tetrahydrocannabinol - cannabidiol - placebo
Drug: tetrahydrocannabinol
Other Names:
  • delta-9-tetrahydrocannabinol
  • THC

Drug: cannabidiol
Other Name: CBD

Drug: Placebo
Experimental: T-P-C
Order of administrations: tetrahydrocannabinol - placebo - cannabidiol
Drug: tetrahydrocannabinol
Other Names:
  • delta-9-tetrahydrocannabinol
  • THC

Drug: cannabidiol
Other Name: CBD

Drug: Placebo
Experimental: C - T - P
Order of administrations: cannabidiol - tetrahydrocannabinol - placebo
Drug: tetrahydrocannabinol
Other Names:
  • delta-9-tetrahydrocannabinol
  • THC

Drug: cannabidiol
Other Name: CBD

Drug: Placebo
Experimental: C - P - T
Order of administrations: cannabidiol - placebo - tetrahydrocannabinol
Drug: tetrahydrocannabinol
Other Names:
  • delta-9-tetrahydrocannabinol
  • THC

Drug: cannabidiol
Other Name: CBD

Drug: Placebo
Experimental: P - T - C
Order of administrations: placebo - tetrahydrocannabinol - cannabidiol
Drug: tetrahydrocannabinol
Other Names:
  • delta-9-tetrahydrocannabinol
  • THC

Drug: cannabidiol
Other Name: CBD

Drug: Placebo
Experimental: P - C - T
Order of administrations: placebo - cannabidiol - tetrahydrocannabinol
Drug: tetrahydrocannabinol
Other Names:
  • delta-9-tetrahydrocannabinol
  • THC

Drug: cannabidiol
Other Name: CBD

Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Ad libitum intake [ Time Frame: 35 minutes after intervention (5 minutes after top-up dose) ]
    Ad libitum intake of a chocolate-based drink

  4. Change of plasma levels of (endo-)cannabinoids and satiety hormones [ Time Frame: One hour after intervention ]
  5. 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.


Other Outcome Measures:
  1. Descriptives [ Time Frame: At inclusion of participants ]
    General subject characteristics, e.g age, restrained eating score and other lifestyle and medical parameters

  2. Appetite ratings [ Time Frame: During each test session ]
    During each test session, appetite ratings will be assessed at several time points

  3. Subjective feelings [ Time Frame: During each test session ]
    During each test sessions, participants will rate the effects of the intervention.

  4. Perception [ Time Frame: 20 minutes after intervention ]
    Participants will rate the intensity of different shades of grey.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112292


Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6703 HD
Sponsors and Collaborators
Wageningen University
Investigators
Principal Investigator: Suzanne EM de Bruijn, MSc Wageningen University
Study Chair: Gerry Jager, Dr. Wageningen University

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02112292     History of Changes
Other Study ID Numbers: NL44758.081.13
2013-002555-14 ( EudraCT Number )
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists