Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men (CannaPREG)

May 21, 2026 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33600
        • Hôpital Haut-Lévêque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • For all subjects:

    • cannabis detected by urinary tetrahydrocannabinol presence,
    • treatment which can interfere with endocannabinoid system (antidepressant, antipsychotics, anxiolytics).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese men
Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese men.
Other: Obese men
Biological measures before, just before, and after lunch, in obese men
Active Comparator: Normal-weight men
Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in normal-weight men.
Other: Normal-weight men
Biological measures before, just before, and after lunch, in normal-weight men.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from 1 hour before lunch to 1 hour after lunch at inclusion day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Neurosteroid and endocannabinoid plasma concentrations will be measured at several points.
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
Endocannabinoid and pregnenolone concentrations will be measured at several points.
Change from 1 hour before lunch to 1 hour after lunch at inclusion day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Study Chair: Lhomme Edouard, Dr, USMR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2017

Primary Completion (Actual)

November 2, 2017

Study Completion (Actual)

November 2, 2017

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2015/33
  • 2013-003477-10 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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