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

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

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.

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

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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