Clinical trial NCT02662816: Non-invasive Quantification of Muscle and Liver Glutathione GSH-MRS
Official title: Feasibility Study of the Quantification of Glutathione Concentrations in Muscle and Liver Using in Vivo Proton Magnetic Resonance Spectroscopy (1H MRS)in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assay Muscle
Liver Glutathione in Healthy Human
Keywords: Glutathione
Liver
Muscle
Proton magnetic resonance spectroscopy
Healthy human
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: UMR 1019 Unité de Nutrition Humaine
name: Laboratoire Régional de Nutrition Humaine
First posted: 2016-01-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Glutathione (glutamyl-cysteinyl-glycine) is the main intracellular compound. It participates also in the detoxification of electrophiles molecules of which paracetamol. It is synthesized in the liver during the postprandial phase, which establishes a stock that is mobilized for the other tissues (muscle)during the postabsorptive period. It is of common knowledge that the decrease in glutathione concentrations associated with ageing could be involved in the development of the degenerative pathologies linked to the old age. These changes could be reversed by an increase in dietary cysteine, the amino acid limiting of the endogenous synthesis of GSH. The development of nutritional strategies aiming at an improvement of the status glutathione requires the determination of its concentration within tissues, where it is active. The quantification of tissue concentrations of glutathione by biochemical techniques requires tissue biopsies. Such a method can be performed for the muscle, but liver biopsy is not feasible outside of a surgery. It is necessary to set up a non-invasive method to quantify muscle and liver glutathione.

Detailed description: The study will validate the detection and the quantification of glutathione in muscle and liver using 1H MRS. The accuracy of the method will be assessed from intra and inter-volunteer measurements. 1H MRS measurements will be performed with the Magnetic Resonance Imaging (MRI) 3 Tesla system of the Hospital, twice for each volunteer.

Prior to the measurements, volunteers will have a protein rich breakfast at home and a protein rich lunch at the Clinical Investigation Center.

Eligibility criteria: Inclusion Criteria:

* - Healthy Volunteers, men or women, from 18 to 35 years old
* Having filled the questionnaire of compatibility in the MRI and having no contraindication in the MRI
* Having given their written, free and informed consent
* Affiliated with a social security system
* 19 \< BMI \< 25 kg.m-2

Exclusion Criteria:

* - Age \< 18 ans ou \> 35 ans
* BMI \< 19 ou \> 25 kg.m-2
* Carrier of a pacemaker, cochlear implants, metallic implants or magnetic element (cf questionnaire of compatibility in the MRI, Appendix 3)
* Under treatment with repeated doses of paracetamol during the 2 weeks preceding the inclusion
* Under treatment in N-acetylcysteine during 2 weeks preceding the inclusion
* Regular sporttraining \> 3 hours / week
* Claustrophobia
* Difficulty of being immobile
* Pregnant women or women who are breast-feeding
* Incapacitated legal (private person of freedom or under guardianship)
* People who cannot be followed and/or compliant in the requirements of the study for psychological, social, family or geographical reasons,
* People already included in another clinical trial

Primary outcomes:
measure: Signal-to-noise ratio of glutathione detected in liver and muscle
timeFrame: 2 h after the lunch.
Secondary outcomes:
measure: Glutathione concentrations in liver
timeFrame: 2 h after the lunch
measure: Glutathione concentrations in muscle
timeFrame: 2 h after the lunch
measure: Glutathione concentrations in means
timeFrame: 2 h after the lunch
measure: Glutathione concentrations in intervariabilities
timeFrame: 2 h after the lunch
measure: Glutathione concentrations in intravariabilities
timeFrame: 2 h after the lunch
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: