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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02112292
Other study ID # NL44758.081.13
Secondary ID 2013-002555-14
Status Completed
Phase N/A
First received March 25, 2014
Last updated May 22, 2017
Start date April 2014
Est. completion date April 16, 2015

Study information

Verified date May 2017
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date April 16, 2015
Est. primary completion date April 16, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
tetrahydrocannabinol

cannabidiol

Placebo


Locations

Country Name City State
Netherlands Wageningen University Wageningen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Descriptives General subject characteristics, e.g age, restrained eating score and other lifestyle and medical parameters At inclusion of participants
Other Appetite ratings During each test session, appetite ratings will be assessed at several time points During each test session
Other Subjective feelings During each test sessions, participants will rate the effects of the intervention. During each test session
Other Perception Participants will rate the intensity of different shades of grey. 20 minutes after intervention
Other Sweet taste intensity 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
Other Liking of sweet taste 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
Primary 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 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 25 minutes after intervention
Secondary Preferences for different kinds of foods 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)
Secondary Ad libitum intake Ad libitum intake of a chocolate-based drink 35 minutes after intervention (5 minutes after top-up dose)
Secondary Change of plasma levels of (endo-)cannabinoids and satiety hormones One hour after intervention
Secondary Polymorphisms The genetic determination of the enzymes responsible for the metabolism of THC and CBD. At test session, i.e., 2 weeks before first intervention