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

NCT ID: NCT02662816

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-07-31

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.

Conditions

Assay Muscle; Liver Glutathione in Healthy Human

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

glutathion

The study will validate the detection and the quantification of glutathione in muscle and liver using 1H MRS

Group Type: EXPERIMENTAL

Proton magnetic resonance spectroscopy (1H MRS)

Intervention Type: DEVICE

a protein rich breakfast at home

Intervention Type: OTHER

a protein rich lunch at the Clinical Investigation Center

Intervention Type: OTHER

Interventions

Proton magnetic resonance spectroscopy (1H MRS)

Intervention Type: DEVICE

a protein rich breakfast at home

Intervention Type: OTHER

a protein rich lunch at the Clinical Investigation Center

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Days
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UMR 1019 Unité de Nutrition Humaine

UNKNOWN

Sponsor Role: collaborator

Laboratoire Régional de Nutrition Humaine

OTHER

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2015-A01426-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

CHU-0253

Identifier Type: -

Identifier Source: org_study_id