ObesityLekkere trekNCT03113474
Profiling the Endocannabinoid Response to Hedonic Eating
A study testing Food palatability in people with Obesity and Food Preferences, run by Wageningen University.
Trial summary
Study into the endocannabinoid response to consuming a palatable versus a neutral food. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Food Preferences
- What is being tested?
- Food palatability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2015to 8 Oct 2015
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (self-report)
- Dutch
- Evaluating one of the used foods as palatable
- Evaluating one of the used foods as neutral
- Hb value between 8.1 and 11.0 mmol/L at screening
Who cannot join
- restraint eating
- lack of appetite
- difficulties eating/swallowing
- endocrine disorders
- energy restricted diet two months prior to study
- weight change > 5 kg in two months prior to study
Show all 11Show fewer
- stomach or bowel disease
- taste or smell disorders (self-report)
- not consuming foods used in the study
- smoking > 1 cigarette per day
- drinking > 21 units alcohol per week
About this study
Study into the endocannabinoid response to consuming a palatable versus a neutral food.
- Conditions
- Obesity, Food Preferences
- Being tested
- Food palatability
- Medical subject headings
- Obesity, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food palatabilityOther
Food palatability is modulated
| Study group | Role | What they receive |
|---|---|---|
| Palatable-neutral | Experimental | Participants are exposed to palatable food in the first test session, and to the neutral food in the second test session. Receives: Other: Food palatability |
| Neutral-palatable | Experimental | Participants are exposed to neutral food in the first test session, and to the palatable food in the second test session. Receives: Other: Food palatability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocannainoid levels
To assess changes in endocannabinoid plasma levels prior to, during and after eating a palatable versus a neutral food
Measured: prior to, during and two hours after eating
Secondary outcomes (2)
Pancreatic polypeptide (pg/ml)
To assess changes in pancreatic polypeptide plasma levels prior to, during and after eating a palatable versus a neutral food
Measured: prior to, during and two hours after eating
Ghrelin (pg/ml)
To assess changes in ghrelin plasma levels prior to, during and after eating a palatable versus a neutral food
Measured: prior to, during and two hours after eating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start15 Sep 2015
- Primary completion8 Oct 2015
- Study completion8 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113474
- Sponsor's protocol ID
- NL51830.081.14
- Acronym
- Lekkere trek
- Status last verified
- May 2017
- First submitted
- 9 Apr 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling the Endocannabinoid Response to Hedonic Eating
- ClinicalTrials.gov ID
- NCT03113474
- Acronym / sponsor ID
- Lekkere trek / NL51830.081.14
- Conditions
- Obesity, Food Preferences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 8 Oct 2015 (actual)
- Study completion
- 8 Oct 2015 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
Study into the endocannabinoid response to consuming a palatable versus a neutral food.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palatable-neutral | Experimental | Other: Food palatabilityParticipants are exposed to palatable food in the first test session, and to the neutral food in the second test session. |
| Neutral-palatable | Experimental | Other: Food palatabilityParticipants are exposed to neutral food in the first test session, and to the palatable food in the second test session. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy (self-report)
- Dutch
- Evaluating one of the used foods as palatable
- Evaluating one of the used foods as neutral
- Hb value between 8.1 and 11.0 mmol/L at screening
Key exclusion criteria (11 listed)
- restraint eating
- lack of appetite
- difficulties eating/swallowing
- endocrine disorders
- energy restricted diet two months prior to study
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 |
|---|---|---|
| Food palatabilityFood palatability is modulated | Other | Neutral-palatable, Palatable-neutral |
Primary outcome
Endocannainoid levels
Time frame: prior to, during and two hours after eating
To assess changes in endocannabinoid plasma levels prior to, during and after eating a palatable versus a neutral food
2 secondary outcomes
Pancreatic polypeptide (pg/ml)
Time frame: prior to, during and two hours after eating
Ghrelin (pg/ml)
Time frame: prior to, during and two hours after eating
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Food palatability in people with Obesity and Food Preferences, run by Wageningen University.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endocannainoid levels (time frame: prior to, during and two hours after eating). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2017.