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

NCT02112292 | Completed

• 2 other identifiers: NL44758.081.132013-002555-14
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensory Science

Outcome Measures

Primary Outcomes (1)

• 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.

  15 minutes after intervention

Secondary Outcomes (5)

• Ranking order of pleasantness of different drinks with different levels of sucrose.

  25 minutes after intervention

• Preferences for different kinds of foods

  45 minutes after intervention (15 minutes after top-up dose)

• Ad libitum intake

  35 minutes after intervention (5 minutes after top-up dose)

• Change of plasma levels of (endo-)cannabinoids and satiety hormones

  One hour after intervention

• Polymorphisms

  At test session, i.e., 2 weeks before first intervention

Other Outcomes (6)

• Descriptives

  At inclusion of participants

• Appetite ratings

  During each test session

• Subjective feelings

  During each test session

Study Arms (6)

T-C-P

EXPERIMENTAL

Order of administrations: tetrahydrocannabinol - cannabidiol - placebo

Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo

T-P-C

EXPERIMENTAL

Order of administrations: tetrahydrocannabinol - placebo - cannabidiol

Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo

C - T - P

EXPERIMENTAL

Order of administrations: cannabidiol - tetrahydrocannabinol - placebo

Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo

C - P - T

EXPERIMENTAL

Order of administrations: cannabidiol - placebo - tetrahydrocannabinol

Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo

P - T - C

EXPERIMENTAL

Order of administrations: placebo - tetrahydrocannabinol - cannabidiol

Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo

P - C - T

EXPERIMENTAL

Order of administrations: placebo - cannabidiol - tetrahydrocannabinol

Drug: tetrahydrocannabinol; Drug: cannabidiol; Drug: Placebo

Interventions

tetrahydrocannabinol DRUG

Also known as: delta-9-tetrahydrocannabinol, THC

C - P - T; C - T - P; P - C - T; P - T - C; T-C-P; T-P-C

cannabidiol DRUG

Also known as: CBD

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6703 HD, Netherlands

Location

MeSH Terms

Interventions

Dronabinol; Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Suzanne EM de Bruijn, MSc

  Wageningen University

  PRINCIPAL INVESTIGATOR

• Gerry Jager, Dr.

  Wageningen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: April 11, 2014
• Study Start: April 1, 2014
• Primary Completion: April 16, 2015
• Study Completion: April 16, 2015
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

NL (1)