Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT02112292
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2014-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}, {'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Descriptives', 'timeFrame': 'At inclusion of participants', 'description': 'General subject characteristics, e.g age, restrained eating score and other lifestyle and medical parameters'}, {'measure': 'Appetite ratings', 'timeFrame': 'During each test session', 'description': 'During each test session, appetite ratings will be assessed at several time points'}, {'measure': 'Subjective feelings', 'timeFrame': 'During each test session', 'description': 'During each test sessions, participants will rate the effects of the intervention.'}, {'measure': 'Perception', 'timeFrame': '20 minutes after intervention', 'description': 'Participants will rate the intensity of different shades of grey.'}, {'measure': 'Sweet taste intensity', 'timeFrame': '15 minutes after intervention', 'description': 'Sucrose intensity of drinks (psychophysics) of drinks with different sucrose concentrations. This will be assessed after six participants and at end of the study.'}, {'measure': 'Liking of sweet taste', 'timeFrame': '15 minutes after intervention', 'description': 'Liking (psychohedonics) of drinks with the different sucrose concentrations. This will be assessed after six participants and at end of the study.'}], 'primaryOutcomes': [{'measure': 'Relation between sweet taste intensity and liking', 'timeFrame': '15 minutes after intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Ranking order of pleasantness of different drinks with different levels of sucrose.', 'timeFrame': '25 minutes after intervention', 'description': 'Ranking order will be assessed after 6 participants and at end of the study'}, {'measure': 'Preferences for different kinds of foods', 'timeFrame': '45 minutes after intervention (15 minutes after top-up dose)', 'description': 'Preference for foods high in one of three macronutrients (carbohydrate, protein, fat) or low in energy'}, {'measure': 'Ad libitum intake', 'timeFrame': '35 minutes after intervention (5 minutes after top-up dose)', 'description': 'Ad libitum intake of a chocolate-based drink'}, {'measure': 'Change of plasma levels of (endo-)cannabinoids and satiety hormones', 'timeFrame': 'One hour after intervention'}, {'measure': 'Polymorphisms', 'timeFrame': 'At test session, i.e., 2 weeks before first intervention', 'description': 'The genetic determination of the enzymes responsible for the metabolism of THC and CBD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sensory Science']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI: 18.5 - 25 kg/m2\n* Incidental cannabis use for at least one year, at least four times per year, but less than once a week.\n* Dutch-speaking\n* Willing to comply with the study procedures\n* Having given written informed consent\n\nExclusion Criteria:\n\n* Not meeting the inclusion criteria\n* Restraint eating (men: score \\> 2.90)\n* Lack of appetite\n* Having difficulties with swallowing/eating\n* Usage of an energy restricted diet during the last two months\n* Weight loss or weight gain of 5kg or more during the last two months\n* Stomach or bowel disease\n* Diabetes, thyroid disease, other endocrine disorders\n* Use of daily medication except paracetamol\n* Having taste or smell disorders (self-report)\n* Being allergic/intolerant for products under study\n* Previously experienced an adverse reaction to cannabinoids (e.g. anxiety, paranoia, nausea)\n* Having (had) a schizophrenia or other psychotic illness\n* Having a family history of schizophrenia or other psychotic illness\n* Working at the Division of Human Nutrition (WUR)\n* Current participation in other research from the Division of Human Nutrition (WUR)'}, 'identificationModule': {'nctId': 'NCT02112292', 'acronym': 'Sweed', 'briefTitle': 'The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking', 'orgStudyIdInfo': {'id': 'NL44758.081.13'}, 'secondaryIdInfos': [{'id': '2013-002555-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T-C-P', 'description': 'Order of administrations: tetrahydrocannabinol - cannabidiol - placebo', 'interventionNames': ['Drug: tetrahydrocannabinol', 'Drug: cannabidiol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'T-P-C', 'description': 'Order of administrations: tetrahydrocannabinol - placebo - cannabidiol', 'interventionNames': ['Drug: tetrahydrocannabinol', 'Drug: cannabidiol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'C - T - P', 'description': 'Order of administrations: cannabidiol - tetrahydrocannabinol - placebo', 'interventionNames': ['Drug: tetrahydrocannabinol', 'Drug: cannabidiol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'C - P - T', 'description': 'Order of administrations: cannabidiol - placebo - tetrahydrocannabinol', 'interventionNames': ['Drug: tetrahydrocannabinol', 'Drug: cannabidiol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'P - T - C', 'description': 'Order of administrations: placebo - tetrahydrocannabinol - cannabidiol', 'interventionNames': ['Drug: tetrahydrocannabinol', 'Drug: cannabidiol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'P - C - T', 'description': 'Order of administrations: placebo - cannabidiol - tetrahydrocannabinol', 'interventionNames': ['Drug: tetrahydrocannabinol', 'Drug: cannabidiol', 'Drug: Placebo']}], 'interventions': [{'name': 'tetrahydrocannabinol', 'type': 'DRUG', 'otherNames': ['delta-9-tetrahydrocannabinol', 'THC'], 'armGroupLabels': ['C - P - T', 'C - T - P', 'P - C - T', 'P - T - C', 'T-C-P', 'T-P-C']}, {'name': 'cannabidiol', 'type': 'DRUG', 'otherNames': ['CBD'], 'armGroupLabels': ['C - P - T', 'C - T - P', 'P - C - T', 'P - T - C', 'T-C-P', 'T-P-C']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['C - P - T', 'C - T - P', 'P - C - T', 'P - T - C', 'T-C-P', 'T-P-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6703 HD', 'city': 'Wageningen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Wageningen University', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Suzanne EM de Bruijn, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University'}, {'name': 'Gerry Jager, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Wageningen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}