redOx MetabolismHEALTHOXNCT02789839
Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism
A study testing Blood test and Medullar test in people with redOx Metabolism, run by University Hospital, Tours at 1 site in France.
Trial summary
Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including kinase activity via inhibition of phosphatases. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- redOx Metabolism
- What is being tested?
- Blood test and Medullar test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to Aug 2017
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age ≥ 18 years old and ≤ 85 ans
- Informed and written consent
- Affiliation to Social Security
Who cannot join
- Subject with an history of hematologic disease
- Subject with an history of tumoral disease with chemotherapy or radiotherapy
- Subject with an history of infectious or inflammatory disease
- Subject taking a treatment in prevention of blood clots
- Subject under guardianship or protection measure
- Subject with in the last 30 days food supplement rich in antioxidant : ascorbic acid, trace elements, etc…
Show all 9Show fewer
- Subject with in the last 30 days treatment with known effect on oxydative metabolism : N-Acetyl-Cysteine, etc…
- Participant to a drug study
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism - HEALTHOX
Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce DNA damage that may lead to the destruction of the cell.
The level of ROS in cells is the result of production (mainly the NADPHoxydase and the mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology team of the university hospital of Tours (France) found that certain antioxidant enzymes are essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3 (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27).
Age potentially affects the level of expression of antioxidant genes, since it was established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of age on the oxidative metabolism of normal hematopoietic cells, and in particular the expression of antioxidant genes. It will provide a reference for analyzing disturbances of oxidative metabolism in blood diseases. The main objective is the comparison of peripheral blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years, 40-59 years and 60-85 years. The level of ROS and the expression of genes encoding the major antioxidant enzymes involved in the regulation of oxidative stress will be studied. The secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a cDNA library (blood and marrow) from healthy volunteers.
- Conditions
- redOx Metabolism
- Being tested
- Blood test, Medullar test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
Blood test of 30mL
Medullar testProcedure or surgery
Medullar test for 2-5mL and a smear
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Experimental | Blood test Medullar test Receives: Procedure: Blood test; Procedure: Medullar test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oxygene reactive species
Number of oxygene reactive species by flow cytometry
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for redOx MetabolismStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier HERAULT, PhD, Principal investigator, CHRU TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789839
- Sponsor's protocol ID
- PHAO 2016 - OH / HEALTHOX
- Acronym
- HEALTHOX
- Status last verified
- Dec 2025
- First submitted
- 30 May 2016
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Guermouche H, Ravalet N, Gallay N, Deswarte C, Foucault A, Beaud J, Rault E, Saindoy E, Lachot S, Martignoles JA, Gissot V, Suner L, Gyan E, Delhommeau F, Herault O, Hirsch P. High prevalence of clonal hematopoiesis in the blood and bone marrow of healthy volunteers. Blood Adv. 2020 Aug 11;4(15):3550-3557. doi: 10.1182/bloodadvances.2020001582.
PubMed 32761230
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism - HEALTHOX
- ClinicalTrials.gov ID
- NCT02789839
- Acronym / sponsor ID
- HEALTHOX / PHAO 2016 - OH / HEALTHOX
- Conditions
- redOx Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 3 Jun 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.
Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce DNA damage that may lead to the destruction of the cell.
The level of ROS in cells is the result of production (mainly the NADPHoxydase and the mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology team of the university hospital of Tours (France) found that certain antioxidant enzymes are essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3 (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27).
Age potentially affects the level of expression of antioxidant genes, since it was established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of age on the oxidative metabolism of normal hematopoietic cells, and in particular the expression of antioxidant genes. It will provide a reference for analyzing disturbances of oxidative metabolism in blood diseases. The main objective is the comparison of peripheral blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years, 40-59 years and 60-85 years. The level of ROS and the expression of genes encoding the major antioxidant enzymes involved in the regulation of oxidative stress will be studied. The secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a cDNA library (blood and marrow) from healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Experimental | Procedure: Blood test, Procedure: Medullar testBlood test Medullar test |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Age ≥ 18 years old and ≤ 85 ans
- Informed and written consent
- Affiliation to Social Security
Key exclusion criteria (9 listed)
- Subject with an history of hematologic disease
- Subject with an history of tumoral disease with chemotherapy or radiotherapy
- Subject with an history of infectious or inflammatory disease
- Subject taking a treatment in prevention of blood clots
- Subject under guardianship or protection measure
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 |
|---|---|---|
| Blood testBlood test of 30mL | Procedure or surgery | Healthy volunteer |
| Medullar testMedullar test for 2-5mL and a smear | Procedure or surgery | Healthy volunteer |
Primary outcome
Number of oxygene reactive species
Time frame: 12 months
Number of oxygene reactive species by flow cytometry
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 30 Dec 2025.
- Results publication: PubMed 32761230Guermouche H, Ravalet N, Gallay N, Deswarte C, Foucault A, Beaud J, Rault E, Saindoy E, Lachot S, Martignoles JA, Gissot V, Suner L, Gyan E, Delhommeau F, Herault O, Hirsch P. High prevalence of clonal hematopoiesis in the blood and bone marrow of healthy volunteers. Blood Adv. 2020 Aug 11;4(15):3550-3557. doi: 10.1182/bloodadvances.2020001582.
Related trials for redOx Metabolism
Recruiting
Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
Bipolar I Disorder, Psychosis
Enrolling by invitation
Open Label Extension Study of NCT06221852
Bipolar I Disorder, Schizoaffective Disorder
Not yet recruitingPhase 4
Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. Metformin Monotherapy
Mitochondria, Metformin
Recruiting
Redox Status and Exercise Training-induced Adaptations
Overweight (BMI > 25), Obesity
Recruiting
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
Adults With Overweight and Obesity
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.
Olivier HERAULT, PhD principal investigator
CHRU TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test and Medullar test in people with redOx Metabolism, run by University Hospital, Tours 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 4 inclusion and 9 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 30 Dec 2025. 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?
Number of oxygene reactive species (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789839, which also lists 1 linked publication.
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 30 Dec 2025.