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Completed

NCT Number: NCT02662816

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

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.

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Key information

Conditions

Assay Muscle Liver Glutathione in Healthy Human

Age range

18 day–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Proton magnetic resonance spectroscopy (1H MRS)

Device

a protein rich breakfast at home

Other

a protein rich lunch at the Clinical Investigation Center

Other

Primary outcomes

  1. Signal-to-noise ratio of glutathione detected in liver and muscle

    Time frame: 2 h after the lunch.

Secondary outcomes

  1. Glutathione concentrations in liver

    Time frame: 2 h after the lunch

  2. Glutathione concentrations in muscle

    Time frame: 2 h after the lunch

  3. Glutathione concentrations in means

    Time frame: 2 h after the lunch

  4. Glutathione concentrations in intervariabilities

    Time frame: 2 h after the lunch

  5. Glutathione concentrations in intravariabilities

    Time frame: 2 h after the lunch

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Laboratoire Régional de Nutrition Humaine
  • UMR 1019 Unité de Nutrition Humaine

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2016
Registry last updated
Jul 26, 2016

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.