Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 582 for:    reduced glutathione

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02662816
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Collaborators:
UMR 1019 Unité de Nutrition Humaine
Laboratoire Régional de Nutrition Humaine
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Assay Muscle Liver Glutathione in Healthy Human Device: Proton magnetic resonance spectroscopy (1H MRS) Other: a protein rich breakfast at home Other: a protein rich lunch at the Clinical Investigation Center Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility Study of the Quantification of Glutathione Concentrations in Muscle and Liver Using in Vivo Proton Magnetic Resonance Spectroscopy (1H MRS)in Human
Study Start Date : June 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

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



Primary Outcome Measures :
  1. Signal-to-noise ratio of glutathione detected in liver and muscle [ Time Frame: 2 h after the lunch. ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662816


Locations
Layout table for location information
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
UMR 1019 Unité de Nutrition Humaine
Laboratoire Régional de Nutrition Humaine

Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02662816     History of Changes
Other Study ID Numbers: CHU-0253
2015-A01426-43 ( Registry Identifier: 2015-A1426-43 )
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Glutathione
Liver
Muscle
Proton magnetic resonance spectroscopy
Healthy human