Assay MuscleNCT02662816
Non-invasive Quantification of Muscle and Liver Glutathione GSH-MRS
A study testing Proton magnetic resonance spectroscopy (1H MRS), a protein rich breakfast at home and a protein rich lunch at the Clinical Investigation Center in people with Assay Muscle and Liver Glutathione in Healthy Human, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 days to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Assay Muscle, Liver Glutathione in Healthy Human
- What is being tested?
- Proton magnetic resonance spectroscopy (1H MRS), a protein rich breakfast at home and a protein rich lunch at the Clinical Investigation Center
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 days to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- - 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
Who cannot join
- - 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Assay Muscle, Liver Glutathione in Healthy Human
- Being tested
- Proton magnetic resonance spectroscopy (1H MRS), a protein rich breakfast at home, a protein rich lunch at the Clinical Investigation Center
- Keywords
- Glutathione, Liver, Muscle, Proton magnetic resonance spectroscopy, Healthy human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton magnetic resonance spectroscopy (1H MRS)Device
a protein rich breakfast at homeOther
a protein rich lunch at the Clinical Investigation CenterOther
| Study group | Role | What they receive |
|---|---|---|
| glutathion | Experimental | The study will validate the detection and the quantification of glutathione in muscle and liver using 1H MRS Receives: Device: Proton magnetic resonance spectroscopy (1H MRS); Other: a protein rich breakfast at home; Other: a protein rich lunch at the Clinical Investigation Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal-to-noise ratio of glutathione detected in liver and muscle
Measured: 2 h after the lunch.
Secondary outcomes (5)
Glutathione concentrations in liver
Measured: 2 h after the lunch
Glutathione concentrations in muscle
Measured: 2 h after the lunch
Glutathione concentrations in means
Measured: 2 h after the lunch
Glutathione concentrations in intervariabilities
Measured: 2 h after the lunch
Glutathione concentrations in intravariabilities
Measured: 2 h after the lunch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assay MuscleStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- UMR 1019 Unité de Nutrition Humaine, Laboratoire Régional de Nutrition Humaine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662816
- Sponsor's protocol ID
- CHU-0253
- Other IDs
- 2015-A01426-43
- Status last verified
- Jul 2016
- First submitted
- 22 Dec 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02662816
- Acronym / sponsor ID
- CHU-0253
- Conditions
- Assay Muscle, Liver Glutathione in Healthy Human
- Keywords
- Glutathione, Liver, Muscle, Proton magnetic resonance spectroscopy, Healthy human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- UMR 1019 Unité de Nutrition Humaine, Laboratoire Régional de Nutrition Humaine
- Study start
- Jun 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glutathion | Experimental | Device: Proton magnetic resonance spectroscopy (1H MRS), Other: a protein rich breakfast at home, Other: a protein rich lunch at the Clinical Investigation CenterThe study will validate the detection and the quantification of glutathione in muscle and liver using 1H MRS |
Who may qualify
- Ages
- 18 days to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (12 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton magnetic resonance spectroscopy (1H MRS) | Device | glutathion |
| a protein rich breakfast at home | Other | glutathion |
| a protein rich lunch at the Clinical Investigation Center | Other | glutathion |
Primary outcome
Signal-to-noise ratio of glutathione detected in liver and muscle
Time frame: 2 h after the lunch.
5 secondary outcomes
Glutathione concentrations in liver
Time frame: 2 h after the lunch
Glutathione concentrations in muscle
Time frame: 2 h after the lunch
Glutathione concentrations in means
Time frame: 2 h after the lunch
Glutathione concentrations in intervariabilities
Time frame: 2 h after the lunch
Glutathione concentrations in intravariabilities
Time frame: 2 h after the lunch
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton magnetic resonance spectroscopy (1H MRS), a protein rich breakfast at home and a protein rich lunch at the Clinical Investigation Center in people with Assay Muscle and Liver Glutathione in Healthy Human, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-noise ratio of glutathione detected in liver and muscle (time frame: 2 h after the lunch.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.