Nutritional Physiological PhenomenaNCT02729584
Gene Polymorphism of Taste Receptors and Circulating Endocannabinoids in Normal Weight and Obese Subjects
An observational study of Nutritional Physiological Phenomena, run by University of Cagliari.
Trial summary
The study aims at evaluating in normal weight and obese subjects those factors such as taste sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid and energy metabolism in order to design personalized nutritional strategies. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Physiological Phenomena
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Sep 2015
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: White Caucasians
Who may be able to join
- Body Mass Index (BMI), range for normal weight subjects 17.5-24.95, for obese subjects 29.6-52.20
- No intake of nutritional supplements for at least six months before the trial
Who cannot join
- major diseases (diabetes, kidney disease, etc.),
- pregnancy or lactation;
- food allergies;
- the use of medications that interfere with taste or smell (e.g., steroids, antihistamines, certain antidepressants).
About this study
The study aims at evaluating in normal weight and obese subjects those factors such as taste sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid and energy metabolism in order to design personalized nutritional strategies.
- Conditions
- Nutritional Physiological Phenomena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Not described | |
| Obese | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocannabinoid plasma levels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Physiological PhenomenaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Brotzu
- Responsible party
- Principal investigator, Sebastiano Banni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729584
- Sponsor's protocol ID
- Cagliari
- Status last verified
- Mar 2016
- First submitted
- 23 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Polymorphism of Taste Receptors and Circulating Endocannabinoids in Normal Weight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02729584
- Acronym / sponsor ID
- Cagliari
- Conditions
- Nutritional Physiological Phenomena
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Brotzu
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Apr 2016 (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 study aims at evaluating in normal weight and obese subjects those factors such as taste sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid and energy metabolism in order to design personalized nutritional strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | – |
| Obese | – | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- White Caucasians
Key inclusion criteria (2 listed)
- Body Mass Index (BMI), range for normal weight subjects 17.5-24.95, for obese subjects 29.6-52.20
- No intake of nutritional supplements for at least six months before the trial
Key exclusion criteria (4 listed)
- major diseases (diabetes, kidney disease, etc.),
- pregnancy or lactation;
- food allergies;
- the use of medications that interfere with taste or smell (e.g., steroids, antihistamines, certain antidepressants).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endocannabinoid plasma levels
Time frame: 1 year
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 6 Apr 2016.
- Individual participant dataSharing planned: No
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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?
An observational study of Nutritional Physiological Phenomena, run by University of Cagliari.
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 2 inclusion and 4 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 6 Apr 2016. 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?
Endocannabinoid plasma levels (time frame: 1 year). 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 6 Apr 2016.