CClinicalTrials.gg
CompletedNCT02662816Updated Jul 26, 2016

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

An interventional study of Proton magnetic resonance spectroscopy (1H MRS) and a protein rich breakfast at home in Assay Muscle and Liver Glutathione in Healthy Human, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Days to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-26.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Days to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Assay Muscle
  • Liver Glutathione in Healthy Human

Keywords

  • Glutathione
  • Liver
  • Muscle
  • Proton magnetic resonance spectroscopy
  • Healthy human
03

In context

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Days to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • 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

Interventions

  • DeviceProton magnetic resonance spectroscopy (1H MRS)
  • Othera protein rich breakfast at home
  • Othera protein rich lunch at the Clinical Investigation Center
06

What researchers measure

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

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02662816
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
UMR 1019 Unité de Nutrition Humaine, Laboratoire Régional de Nutrition Humaine
Responsible party
Sponsor
First posted
Jan 26, 2016
Start date
Jun 2016
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Jul 26, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion