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Completed

NCT Number: NCT01223157

Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service of Endocrinology, Diabetology, metabolic diseases - Hôpital du Haut Lévêque - CHU de BORDEAUX

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 :

  • 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

Exclusion criteria

  • treatments that could interfere with the endocannabinoid system (anxiolytics, anticonvulsivants, antidepressants drugs)
  • pregnancy, breast feeding

Treatment and study plan

Biological data

Biological

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    to study fasting saliva concentration of 2-AG (2 arachidonoylglycerol), OEA (oleoylethanolamide), PEA(palmitoyléthanolamide) between obese and lean subjects

  2. 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

    To study the effects of food intake on the levels of saliva endocannabinoids both in normal weight and obese subjects

  3. 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

    To study the effects of food intake on the levels of plasma endocannabinoids both in normal weight and obese subjects

  4. 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

    To look for a correlation between saliva and plasma endocannabinoids

  5. 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

    To look for a relationship between saliva or plasma endocannabinoids and gut hormones

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: SALIVENDO

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 18, 2010
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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