ObesityCannaPREGNCT03157778
Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men
A study testing Obese men and Normal-weight men in people with Obesity, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese and normal-weight men subjects, to research a dysfunction in the negative feed-back between pregnenolone and CB1 ligand in obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- Obese men and Normal-weight men
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2017to 2 Nov 2017
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese subjects:
- men,
- aged between 18 and 65 years,
- BMI>30kg/m2.
- Normal-weight subjects:
- men,
- aged between 18 and 65 years,
- BMI<25kg/m2.
Who cannot join
- For all subjects:
- cannabis detected by urinary tetrahydrocannabinol presence,
- treatment which can interfere with endocannabinoid system (antidepressant, antipsychotics, anxiolytics).
Trial locations and contacts
1 site in 1 country.
About this study
Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese and normal-weight men subjects, to research a dysfunction in the negative feed-back between pregnenolone and CB1 ligand in obese subjects. This dysfunction could participate to the hyperactivity of endocannabinoid system saw in obesity.
Read the detailed description
Endocannabinoid system is an orexigenic key system, controlling the energy balance. It is composed of receptors (ex: CB1), of endogenous ligands, the endocannabinoids (ex: anandamide and 2- arachidonoylglycerol) and of enzymes implied in the synthesis and the degradation of the endocannabinoids. Researches resulting from our group highlighted anomalies of the plasmatic concentrations of endocannabinoid, in obese subject compared to normal-weight subject. Those being higher in obese subject with a flatness of post prandial reduction of AEA, so maintenance of elevated levels which can facilitate the food catch and create a metabolic vicious circle. In addition, prestigious research resulting from our collaborators highlighted in the animal that exposure to tetrahydrocannabinol (THC, ligand exogenic of CB1) induced the synthesis of pregnenolone (neurosteroid) which, by an autocrine effect on the CB1, inhibited the effects of the THC. In particular one of the principal behavioural effects: the food intake.
We want to measure pregnenolone and endocannabinoid concentrations in men blood samples, to observe if this association exists in fasting conditions and over a meal in normal-weight and obese subjects. Obese subjects will be recruited during an hospitalization, while normal subject will be recruited by a poster at Bordeaux university and Haut-Leveque hospital. They will be included at Haut-Leveque hospital during morning at hospital.
- Conditions
- Obesity
- Being tested
- Obese men, Normal-weight men
- Keywords
- pregnenolone, endocannabinoid, food intake, type-1 cannabinoid receptor
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obese menOther
Biological measures before, just before, and after lunch, in obese men
Normal-weight menOther
Biological measures before, just before, and after lunch, in normal-weight men.
| Study group | Role | What they receive |
|---|---|---|
| Obese men | Experimental | Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese men. Receives: Other: Obese men |
| Normal-weight men | Active comparator | Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in normal-weight men. Receives: Other: Normal-weight men |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pregnenolon plasmatic concentration in both groups.
Pregnenolon plasmatic concentration will be measured at several points.
Measured: Change from 1 hour before lunch to 1 hour after lunch at inclusion day
Secondary outcomes (2)
Comparison of neurosteroid plasma concentrations and endocannabinoid plasma concentrations
Neurosteroid and endocannabinoid plasma concentrations will be measured at several points.
Measured: Change from 1 hour before lunch to 1 hour after lunch at inclusion day
Comparison of endocannabinoid plasma concentration and pregnenolone plasma concentration
Endocannabinoid and pregnenolone concentrations will be measured at several points.
Measured: Change from 1 hour before lunch to 1 hour after lunch at inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start30 May 2017
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Obese men versus normal-weight men
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lhomme Edouard, Dr, Study chair, USMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157778
- Sponsor's protocol ID
- CHUBX 2015/33
- Other IDs
- 2013-003477-10
- Acronym
- CannaPREG
- Status last verified
- Jan 2018
- First submitted
- 5 May 2017
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men
- ClinicalTrials.gov ID
- NCT03157778
- Acronym / sponsor ID
- CannaPREG / CHUBX 2015/33
- Conditions
- Obesity
- Keywords
- pregnenolone, endocannabinoid, food intake, type-1 cannabinoid receptor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 30 May 2017 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 17 May 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.
Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese and normal-weight men subjects, to research a dysfunction in the negative feed-back between pregnenolone and CB1 ligand in obese subjects. This dysfunction could participate to the hyperactivity of endocannabinoid system saw in obesity.
Detailed description
Endocannabinoid system is an orexigenic key system, controlling the energy balance. It is composed of receptors (ex: CB1), of endogenous ligands, the endocannabinoids (ex: anandamide and 2- arachidonoylglycerol) and of enzymes implied in the synthesis and the degradation of the endocannabinoids. Researches resulting from our group highlighted anomalies of the plasmatic concentrations of endocannabinoid, in obese subject compared to normal-weight subject. Those being higher in obese subject with a flatness of post prandial reduction of AEA, so maintenance of elevated levels which can facilitate the food catch and create a metabolic vicious circle. In addition, prestigious research resulting from our collaborators highlighted in the animal that exposure to tetrahydrocannabinol (THC, ligand exogenic of CB1) induced the synthesis of pregnenolone (neurosteroid) which, by an autocrine effect on the CB1, inhibited the effects of the THC. In particular one of the principal behavioural effects: the food intake.
We want to measure pregnenolone and endocannabinoid concentrations in men blood samples, to observe if this association exists in fasting conditions and over a meal in normal-weight and obese subjects. Obese subjects will be recruited during an hospitalization, while normal subject will be recruited by a poster at Bordeaux university and Haut-Leveque hospital. They will be included at Haut-Leveque hospital during morning at hospital.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Obese men versus normal-weight men
| Arm | Type | Receives |
|---|---|---|
| Obese men | Experimental | Other: Obese menMeasured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese men. |
| Normal-weight men | Active comparator | Other: Normal-weight menMeasured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in normal-weight men. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Obese subjects:
- Normal-weight subjects:
Key exclusion criteria (3 listed)
- For all subjects:
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 |
|---|---|---|
| Obese menBiological measures before, just before, and after lunch, in obese men | Other | Obese men |
| Normal-weight menBiological measures before, just before, and after lunch, in normal-weight men. | Other | Normal-weight men |
Primary outcome
Comparison of pregnenolon plasmatic concentration in both groups.
Time frame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day
Pregnenolon plasmatic concentration will be measured at several points.
2 secondary outcomes
Comparison of neurosteroid plasma concentrations and endocannabinoid plasma concentrations
Time frame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day
Comparison of endocannabinoid plasma concentration and pregnenolone plasma concentration
Time frame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day
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 22 May 2026.
- 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.
Lhomme Edouard, Dr study chair
USMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obese men and Normal-weight men 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 8 inclusion and 3 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 22 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?
Comparison of pregnenolon plasmatic concentration in both groups. (time frame: Change from 1 hour before lunch to 1 hour after lunch at inclusion day). 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 22 May 2026.