Non-invasive Quantification of Muscle and Liver Glutathione GSH-MRS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility Study of the Quantification of Glutathione Concentrations in Muscle and Liver Using in Vivo Proton Magnetic Resonance Spectroscopy (1H MRS)in Human

Conditions
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Assay Muscle, Liver Glutathione in Healthy Human

Intervention / Treatment
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* Device: Proton magnetic resonance spectroscopy (1H MRS)
* Other: a protein rich breakfast at home
* Other: a protein rich lunch at the Clinical Investigation Center


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Days
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glutathion<br>The study will validate the detection and the quantification of glutathione in muscle and liver using 1H MRS | Device: Proton magnetic resonance spectroscopy (1H MRS)<br> <br> Other: a protein rich breakfast at home<br> <br> Other: a protein rich lunch at the Clinical Investigation Center<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal-to-noise ratio of glutathione detected in liver and muscle |  | 2 h after the lunch. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glutathione concentrations in liver |  | 2 h after the lunch | 
| Glutathione concentrations in muscle |  | 2 h after the lunch | 
| Glutathione concentrations in means |  | 2 h after the lunch | 
| Glutathione concentrations in intervariabilities |  | 2 h after the lunch | 
| Glutathione concentrations in intravariabilities |  | 2 h after the lunch | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glutathione, Liver, Muscle, Proton magnetic resonance spectroscopy, Healthy human