NCT02662816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

1 month

First QC Date

December 22, 2015

Last Update Submit

July 25, 2016

Conditions

Assay MuscleLiver Glutathione in Healthy Human

Keywords

GlutathioneLiverMuscleProton magnetic resonance spectroscopyHealthy human

Outcome Measures

Primary Outcomes (1)

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

    2 h after the lunch.

Secondary Outcomes (5)

  • Glutathione concentrations in liver

    2 h after the lunch

  • Glutathione concentrations in muscle

    2 h after the lunch

  • Glutathione concentrations in means

    2 h after the lunch

  • Glutathione concentrations in intervariabilities

    2 h after the lunch

  • Glutathione concentrations in intravariabilities

    2 h after the lunch

Study Arms (1)

glutathion

EXPERIMENTAL

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 homeOther: a protein rich lunch at the Clinical Investigation Center

Interventions

Proton magnetic resonance spectroscopy (1H MRS)DEVICE
glutathion
a protein rich breakfast at homeOTHER
glutathion
a protein rich lunch at the Clinical Investigation CenterOTHER
glutathion

Eligibility Criteria

Age18 Days - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 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
  • \< BMI \< 25 kg.m-2

You may not qualify if:

  • \- 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Proton Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Magnetic Resonance SpectroscopySpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

January 26, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

FR(1)