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

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

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.

Study Overview

• Status: Completed
• Conditions: Assay Muscle; Liver Glutathione in Healthy Human
• Intervention / Treatment: Device: Proton magnetic resonance spectroscopy (1H MRS); Other: a protein rich breakfast at home; Other: a protein rich lunch at the Clinical Investigation Center

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: glutathion; 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); Other: a protein rich breakfast at home; Other: a protein rich lunch at the Clinical Investigation Center

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: UMR 1019 Unité de Nutrition Humaine; Laboratoire Régional de Nutrition Humaine

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (ESTIMATE): January 26, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Healthy human; Liver; Glutathione; Muscle; Proton magnetic resonance spectroscopy
• Other Study ID Numbers: CHU-0253; 2015-A01426-43 (REGISTRY: 2015-A1426-43)