Assay Muscle Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 35 Years |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand | Laboratoire Régional de Nutrition Humaine, UMR 1019 Unité de Nutrition Humaine |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Signal-to-noise ratio of glutathione detected in liver and muscle | 2 h after the lunch. | No | |
| Secondary | Glutathione concentrations in liver | 2 h after the lunch | No | |
| Secondary | Glutathione concentrations in muscle | 2 h after the lunch | No | |
| Secondary | Glutathione concentrations in means | 2 h after the lunch | No | |
| Secondary | Glutathione concentrations in intervariabilities | 2 h after the lunch | No | |
| Secondary | Glutathione concentrations in intravariabilities | 2 h after the lunch | No |