Appetite RegulationNCT02310347
Influence of a Medicinal Cannabinoid Agonist on Responses to Food Images and Food Intake
A study testing dronabinol in people with Appetite Regulation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to examine the influence of a medicinal cannabinoid agonist versus placebo on behavioural and gut peptide responses to food images and food intake. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation
- What is being tested?
- dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For healthy volunteers:
- 20 ≤ BMI ≤ 25
- Age 18-60
- Right handed
- Stable body weight for at least 3 consecutive months at start of study and no history of behavioural, therapeutic or surgical treatment aiming at or leading to weight loss/gain
- For obese subjects:
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- BMI > 30
- Age 18-60
- Right handed
- Stable body weight for at least 3 consecutive months at start of the study and no behavioural, therapeutic or surgical treatment aiming at or leading to weight loss/gain for at least 3 consecutive months
- For FD patients:
- FD diagnosis according to 'Rome III' criteria
- Age 18-60
- Right handed
- 5% weight loss since onset of symptoms
Who cannot join
- Medical conditions (current or history):
- Abdominal/thoracic surgery except appendectomy
- Gastrointestinal, endocrine (especially diabetes), or neurological diseases
- Cardiovascular, respiratory, renal or urinary diseases
- Hypertension
- Food or drug allergies
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- Head trauma with loss of consciousness
- Psychiatric disorders:
- Eating disorders
- Psychotic disorders
- Major depressive disorder
- Somatoform disorder
- Medication use:
- No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
- All medication except oral contraception;
- Known allergy to dronabinol and/or sesam oil
- Pregnancy, plans to conceive or refusal to take adequate precaution to avoid pregnancy
- Subjects who refuse to abstain from driving during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Medicinal Cannabinoid Agonist on Behavioural Responses to Food Images and Food Intake: Role of Gut Peptides
The purpose of this study is to examine the influence of a medicinal cannabinoid agonist versus placebo on behavioural and gut peptide responses to food images and food intake.
- Conditions
- Appetite Regulation
- Being tested
- dronabinol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dronabinolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Marinol | Experimental | * generic name: dronabinol
* dosage: 0.1 mg/kg
* frequency: 2 times a single dose
* duration: acute adminstration Receives: Drug: dronabinol |
| Placebo | Placebo comparator | Empty hard gelatin capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural responses to food images and food intake
Scores on Visual Analogue Scales
Measured: 2 years
Gut peptide responses
Concentrations of gut peptide levels will be determined using radioimmunoassays
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2016
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetite RegulationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas Van Oudenhove, MD, PhD, Principal investigator, University Hospitals Leuven, campus Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310347
- Sponsor's protocol ID
- S54673
- Other IDs
- 2012-003017-33
- Status last verified
- Jul 2024
- First submitted
- 19 Nov 2014
- Last updated
- 10 Jul 2024
- Results posted
- No
Publications
Weltens N, Depoortere I, Tack J, Van Oudenhove L. Effect of acute Delta9-tetrahydrocannabinol administration on subjective and metabolic hormone responses to food stimuli and food intake in healthy humans: a randomized, placebo-controlled study. Am J Clin Nutr. 2019 Apr 1;109(4):1051-1063. doi: 10.1093/ajcn/nqz007.
PubMed 30949710
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Medicinal Cannabinoid Agonist on Behavioural Responses to Food Images and Food Intake: Role of Gut Peptides
- ClinicalTrials.gov ID
- NCT02310347
- Acronym / sponsor ID
- S54673
- Conditions
- Appetite Regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the influence of a medicinal cannabinoid agonist versus placebo on behavioural and gut peptide responses to food images and food intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marinol | Experimental | Drug: dronabinol* generic name: dronabinol * dosage: 0.1 mg/kg * frequency: 2 times a single dose * duration: acute adminstration |
| Placebo | Placebo comparator | Drug: PlaceboEmpty hard gelatin capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 20 ≤ BMI ≤ 25
- Age 18-60
- Right handed
- Stable body weight for at least 3 consecutive months at start of study and no history of behavioural, therapeutic or surgical treatment aiming at or leading to weight loss/gain
- BMI > 30
Key exclusion criteria (18 listed)
- Medical conditions (current or history):
- Psychiatric disorders:
- Medication use:
- Known allergy to dronabinol and/or sesam oil
- Pregnancy, plans to conceive or refusal to take adequate precaution to avoid pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dronabinol | Drug | Marinol |
| Placebo | Drug | Placebo |
Primary outcome
Behavioural responses to food images and food intake
Time frame: 2 years
Scores on Visual Analogue Scales
Gut peptide responses
Time frame: 2 years
Concentrations of gut peptide levels will be determined using radioimmunoassays
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 30949710Weltens N, Depoortere I, Tack J, Van Oudenhove L. Effect of acute Delta9-tetrahydrocannabinol administration on subjective and metabolic hormone responses to food stimuli and food intake in healthy humans: a randomized, placebo-controlled study. Am J Clin Nutr. 2019 Apr 1;109(4):1051-1063. doi: 10.1093/ajcn/nqz007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Van Oudenhove, MD, PhD principal investigator
University Hospitals Leuven, campus Gasthuisberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dronabinol in people with Appetite Regulation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural responses to food images and food intake (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.