ObesitySALIVENDONCT01223157
Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index
A study testing Biological data in people with Obesity, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive procedures. The investigators managed in the lab to determine the levels of endocannabinoids in a small number of subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Biological data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Oct 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese patients :
- Age between 18 and 65 yrs
- BMI (Body Mass Index) > 30 kg/m²
- Signed inform Consent before any investigation related to the study
- No smoker
- Normal weight subjects :
Show all 10Show fewer
- Age between 18 and 65 yrs
- BMI between 18 and 25 kg/m²
- Signed inform Consent before any investigation related to the study
- No smoker
Who cannot join
- treatments that could interfere with the endocannabinoid system (anxiolytics, anticonvulsivants, antidepressants drugs)
- pregnancy, breast feeding
Trial locations and contacts
1 site in 1 country.
France1 site
Service of Endocrinology, Diabetology, metabolic diseases - Hôpital du Haut Lévêque - CHU de BORDEAUX
Bordeaux
About this study
Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive procedures. The investigators managed in the lab to determine the levels of endocannabinoids in a small number of subjects. The aim of the study is to confirm that salivary is a useful tool to evaluate the activity of the ECS both in normal weight and obese subjects that are characterised by a hyperactivity of the system. Therefore, the first objective of the study is to compare the fasting level of salivary anandamide between 12 obese patients and 12 normal weight subjects.
Read the detailed description
The prevalence of obesity keeps increasing in industrialized countries. However, efficient treatments of this chronic disease are still lacking. A better understanding of the systems that regulate energy balance and eating behavior is mandatory to better understand the disease and find appropriate treatments. The endocannabinoid system (ECS) which comprises cannabinoid receptors, such as CB1 and CB2, endogenous ligands (named endocannabinoids) and specific biosynthetic and degradative pathways is a key system in the regulation of energy balance and obesity. Obesity is characterised by an hyperactivity of the system both in animal and humans. Moreover, the activity of the ECS is influenced by feeding status although only one study has only been performed in humans. The investigation of the ECS in humans needs invasive procedure (blood sampling or adipose or liver biopsy). The aim of our study is to evaluate a new tool for the ECS evaluation in humans i e the determinations of saliva concentration of endocannabinoids both in normal weight and obese subjects before and after food intake. Blood and saliva sampling will be performed after an overnight fast, one hour before, just before and one hour after a lunch in12 normal weight subjects and 12 obese characterised with anthropometric (Weight, height, BMI (Body Mass Index), waist circumference, blood pressure) and metabolic (glycaemia, insulin, lipid profile, liver profile) evaluations. The endocannabinoids concentrations will be measured with mass spectrometry in blood and saliva and gut hormones (PYY (peptide YY) and ghrelin) will be measured in plasma.
- Conditions
- Obesity
- Being tested
- Biological data
- Keywords
- obesity, endocannabinoids
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological dataBiological
Height, Weight, waist circumference and systolic and diastolic blood pressure will be measured in obese and normal subjects. Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch. This will allow a measurement of fasting glycaemia and insulin, fasting cholesterol and triglycerides, liver profile. Endocannabinoids will be measured both in plasma and saliva at each time point. Gut hormones (Ghrelin and PYY) will be measured before, just before and after lunch in plasma.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Experimental | Not described Receives: Biological: Biological data |
| Normal weight subjects | Experimental | Not described Receives: Biological: Biological data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anandamide(AEA)concentration
The primary outcome will be the difference of fasting saliva anandamide (AEA) concentration between obese and normal weight subjects.
Measured: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Secondary outcomes (5)
2-AG( 2 arachidonoylglycerol), OEA (oleoylethanolamide), PEA (palmitoyléthanolamide) concentrations
to study fasting saliva concentration of 2-AG (2 arachidonoylglycerol), OEA (oleoylethanolamide), PEA(palmitoyléthanolamide) between obese and lean subjects
Measured: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Food intake influence on saliva endocannabinoids
To study the effects of food intake on the levels of saliva endocannabinoids both in normal weight and obese subjects
Measured: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Plasma endocannabinoids level
To study the effects of food intake on the levels of plasma endocannabinoids both in normal weight and obese subjects
Measured: Blood sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Correlation between saliva and plasma endocannabinoids
To look for a correlation between saliva and plasma endocannabinoids
Measured: Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Relationship between saliva or plasma endocannabinoids and gut hormones
To look for a relationship between saliva or plasma endocannabinoids and gut hormones
Measured: Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2010
- Study completionOct 2010
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.
- More trials run by University Hospital, BordeauxThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blandine GATTA, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223157
- Sponsor's protocol ID
- CHUBX 2010/14
- Other IDs
- 2010-A00766-33
- Acronym
- SALIVENDO
- Status last verified
- Apr 2011
- First submitted
- 15 Oct 2010
- Last updated
- 26 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index
- ClinicalTrials.gov ID
- NCT01223157
- Acronym / sponsor ID
- SALIVENDO / CHUBX 2010/14
- Conditions
- Obesity
- Keywords
- obesity, endocannabinoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Oct 2010 (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.
Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive procedures. The investigators managed in the lab to determine the levels of endocannabinoids in a small number of subjects. The aim of the study is to confirm that salivary is a useful tool to evaluate the activity of the ECS both in normal weight and obese subjects that are characterised by a hyperactivity of the system. Therefore, the first objective of the study is to compare the fasting level of salivary anandamide between 12 obese patients and 12 normal weight subjects.
Detailed description
The prevalence of obesity keeps increasing in industrialized countries. However, efficient treatments of this chronic disease are still lacking. A better understanding of the systems that regulate energy balance and eating behavior is mandatory to better understand the disease and find appropriate treatments. The endocannabinoid system (ECS) which comprises cannabinoid receptors, such as CB1 and CB2, endogenous ligands (named endocannabinoids) and specific biosynthetic and degradative pathways is a key system in the regulation of energy balance and obesity. Obesity is characterised by an hyperactivity of the system both in animal and humans. Moreover, the activity of the ECS is influenced by feeding status although only one study has only been performed in humans. The investigation of the ECS in humans needs invasive procedure (blood sampling or adipose or liver biopsy). The aim of our study is to evaluate a new tool for the ECS evaluation in humans i e the determinations of saliva concentration of endocannabinoids both in normal weight and obese subjects before and after food intake. Blood and saliva sampling will be performed after an overnight fast, one hour before, just before and one hour after a lunch in12 normal weight subjects and 12 obese characterised with anthropometric (Weight, height, BMI (Body Mass Index), waist circumference, blood pressure) and metabolic (glycaemia, insulin, lipid profile, liver profile) evaluations. The endocannabinoids concentrations will be measured with mass spectrometry in blood and saliva and gut hormones (PYY (peptide YY) and ghrelin) will be measured in plasma.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients | Experimental | Biological: Biological data |
| Normal weight subjects | Experimental | Biological: Biological data |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18 and 65 yrs
- BMI (Body Mass Index) > 30 kg/m²
- Signed inform Consent before any investigation related to the study
- No smoker
- Age between 18 and 65 yrs
Key exclusion criteria (2 listed)
- treatments that could interfere with the endocannabinoid system (anxiolytics, anticonvulsivants, antidepressants drugs)
- pregnancy, breast feeding
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 |
|---|---|---|
| Biological dataHeight, Weight, waist circumference and systolic and diastolic blood pressure will be measured in obese and normal subjects. Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch. This will allow a measurement of fasting glycaemia and insulin, fasting cholesterol and triglycerides, liver profile. Endocannabinoids will be measured both in plasma and saliva at each time point. Gut hormones (Ghrelin and PYY) will be measured before, just before and after lunch in plasma. | Biological | Normal weight subjects, Obese patients |
Primary outcome
Anandamide(AEA)concentration
Time frame: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
The primary outcome will be the difference of fasting saliva anandamide (AEA) concentration between obese and normal weight subjects.
5 secondary outcomes
2-AG( 2 arachidonoylglycerol), OEA (oleoylethanolamide), PEA (palmitoyléthanolamide) concentrations
Time frame: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Food intake influence on saliva endocannabinoids
Time frame: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Plasma endocannabinoids level
Time frame: Blood sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Correlation between saliva and plasma endocannabinoids
Time frame: Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
Relationship between saliva or plasma endocannabinoids and gut hormones
Time frame: Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch
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 26 May 2026.
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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.
Blandine GATTA, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological data in people with Obesity, run by University Hospital, Bordeaux at 1 site in France.
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 10 inclusion and 2 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 26 May 2026. 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 France. 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. 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?
Anandamide(AEA)concentration (time frame: Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch). 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 26 May 2026.