Lupus ErythematosusISOLEDNCT03421184
Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus
A study testing blood sample, urine sample and food questionnaire in people with Lupus Erythematosus and Rheumatoid Arthritis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The study aims at determining if dietary phytoestrogens can be risk factors for Systemic Lupus Erythematosus (SLE). Dietary enquiry and phytoestrogens measurements will be performed in blood and urine of patients with SLE in an active phase of the disease, in patient with other autoimmune diseases and in healthy… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Rheumatoid Arthritis, Autoimmune Thrombocytopenia
- What is being tested?
- blood sample, urine sample and food questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2018to 26 Jun 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group : Systemic Lupus Erythematosus :
- Premenopausal women over 18
- with acute LEAD flare
- having given informed consent
- and being covered by social insurance.
- Group : Autoimmune diseases :
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- Premenopausal women of matching age with other autoimmune disease,
- having given informed consent
- and being covered by social insurance.
- Healthy controls :
- Premenopausal women over 18,
- having given informed consent,
- and being covered by social insurance.
Who cannot join
- Group Systemic Lupus Erythematosus and group autoimmune diseases
- Human Immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis C virus (HBV) sero-positivity;
- pregnant or lactating women;
- menopausal women;
- patient in remission of quiescent phase of her pathology;
- Healthy controls :
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- HIV, HCV or HBV sero-positivity;
- pregnant or lactating women;
- menopausal women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Phytoestrogens in Blood and Urine of Female Patient With Acute Systemic Lupus Erythematosus
The study aims at determining if dietary phytoestrogens can be risk factors for Systemic Lupus Erythematosus (SLE). Dietary enquiry and phytoestrogens measurements will be performed in blood and urine of patients with SLE in an active phase of the disease, in patient with other autoimmune diseases and in healthy volunteers. Subjects will be premenopausal women and when possible at a define stage of the menstrual cycle. Free blood estradiol will be assayed as a confounding risk factor.
Read the detailed description
SLE is a disease occurring in 90% of the cases in pre-menopausal women. The causing factors are largely unknown even though genetic and environmental factors have already been identified. Estrogens, on one side, have been shown to negatively influence the incidence and severity of the disease while testosterone and progesterone on the other side are thought to be protective. Endocrine disruptors can potentially influence the occurrence and severity of the disease. Among these disruptors, soy isoflavones which are ubiquitous in modern processed food are known to be estrogenic and anti-androgenic. Their depleting effect on luteinizing hormone (LH) secretion can also lead to progesterone plasma level impairments. For these reasons, estrogenic isoflavones, appear as potential environmental risk factors for SLE and its flares. Although some data exist in transgenic rodent, there is actually no clinical data in young women.
The study is an observational, monocentric, preliminary study aiming at determining if estrogenic isoflavones can be risk factors for SLE. No treatment is planned. The intervention will be the collection of extra blood and urine samples on SLE subjects and on autoimmune and healthy counterparts.
Consumers are unintentionally exposed to estrogenic isoflavones through their diet. A dietary habit enquiry and a 48h dietary recall (based on pharmacokinetics of soy-isoflavones) will be proposed to the included subjects. Urine and blood samples collected during a clinical visit performed 7 days after the onset of previous menses will be analyzed for soy isoflavones, metabolites and for enterolactone both free and conjugated. Free estradiol will be assayed as a potential confounding risk factor.
- Being tested
- blood sample, urine sample, food questionnaire, hair
- Keywords
- autoimmune disease, endocrine disruptors, isoflavones, lignans, diet exposure, risk factor
- Medical subject headings
- Arthritis, Rheumatoid, Purpura, Thrombocytopenic, Idiopathic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
urine sampleOther
10 ml
food questionnaireOther
dietary habit enquiry and a 48h dietary
hairOther
lock of hair
| Study group | Role | What they receive |
|---|---|---|
| Patient with Systemic Lupus Erythematosus | Experimental | 30 women with SLE Receives: Other: blood sample; Other: urine sample; Other: food questionnaire; Other: hair |
| Patients with other autoimmune diseases | Active comparator | 20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia Receives: Other: blood sample; Other: urine sample; Other: food questionnaire; Other: hair |
| Healthy control | Active comparator | 30 healthy control women Receives: Other: blood sample; Other: urine sample; Other: food questionnaire; Other: hair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of different isoflavones and enterolactone
in the blood and urine of patients and healthy controls
Measured: At baseline (day 0)
Secondary outcomes (1)
Quantification of free estradiol concentrations
in the blood and urine of patients and healthy controls
Measured: At baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start26 Nov 2018
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François VIALLARD, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421184
- Sponsor's protocol ID
- CHUBX 2017/08
- Other IDs
- 2017-A02679-44
- Acronym
- ISOLED
- Status last verified
- Jul 2023
- First submitted
- 29 Jan 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bensaada S, Raymond I, Breton M, Pellegrin I, Viallard JF, Bennetau-Pelissero C. Development of an Assay for Soy Isoflavones in Women's Hair. Nutrients. 2022 Sep 1;14(17):3619. doi: 10.3390/nu14173619.
PubMed 36079877Bensaada S, Raymond I, Pellegrin I, Viallard JF, Bennetau-Pelissero C. Validation of ELISAs for Isoflavones and Enterolactone for Phytoestrogen Intake Assessment in the French Population. Nutrients. 2023 Feb 15;15(4):967. doi: 10.3390/nu15040967.
PubMed 36839324
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Phytoestrogens in Blood and Urine of Female Patient With Acute Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03421184
- Acronym / sponsor ID
- ISOLED / CHUBX 2017/08
- Keywords
- autoimmune disease, endocrine disruptors, isoflavones, lignans, diet exposure, risk factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 5 Feb 2018 (actual)
- 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.
The study aims at determining if dietary phytoestrogens can be risk factors for Systemic Lupus Erythematosus (SLE). Dietary enquiry and phytoestrogens measurements will be performed in blood and urine of patients with SLE in an active phase of the disease, in patient with other autoimmune diseases and in healthy volunteers. Subjects will be premenopausal women and when possible at a define stage of the menstrual cycle. Free blood estradiol will be assayed as a confounding risk factor.
Detailed description
SLE is a disease occurring in 90% of the cases in pre-menopausal women. The causing factors are largely unknown even though genetic and environmental factors have already been identified. Estrogens, on one side, have been shown to negatively influence the incidence and severity of the disease while testosterone and progesterone on the other side are thought to be protective. Endocrine disruptors can potentially influence the occurrence and severity of the disease. Among these disruptors, soy isoflavones which are ubiquitous in modern processed food are known to be estrogenic and anti-androgenic. Their depleting effect on luteinizing hormone (LH) secretion can also lead to progesterone plasma level impairments. For these reasons, estrogenic isoflavones, appear as potential environmental risk factors for SLE and its flares. Although some data exist in transgenic rodent, there is actually no clinical data in young women.
The study is an observational, monocentric, preliminary study aiming at determining if estrogenic isoflavones can be risk factors for SLE. No treatment is planned. The intervention will be the collection of extra blood and urine samples on SLE subjects and on autoimmune and healthy counterparts.
Consumers are unintentionally exposed to estrogenic isoflavones through their diet. A dietary habit enquiry and a 48h dietary recall (based on pharmacokinetics of soy-isoflavones) will be proposed to the included subjects. Urine and blood samples collected during a clinical visit performed 7 days after the onset of previous menses will be analyzed for soy isoflavones, metabolites and for enterolactone both free and conjugated. Free estradiol will be assayed as a potential confounding risk factor.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with Systemic Lupus Erythematosus | Experimental | Other: blood sample, Other: urine sample, Other: food questionnaire, Other: hair30 women with SLE |
| Patients with other autoimmune diseases | Active comparator | Other: blood sample, Other: urine sample, Other: food questionnaire, Other: hair20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia |
| Healthy control | Active comparator | Other: blood sample, Other: urine sample, Other: food questionnaire, Other: hair30 healthy control women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Group : Systemic Lupus Erythematosus :
- Group : Autoimmune diseases :
- Healthy controls :
Key exclusion criteria (9 listed)
- Group Systemic Lupus Erythematosus and group autoimmune diseases
- Healthy controls :
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 sample25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation | Other | Healthy control, Patient with Systemic Lupus Erythematosus, Patients with other autoimmune diseases |
| urine sample10 ml | Other | Healthy control, Patient with Systemic Lupus Erythematosus, Patients with other autoimmune diseases |
| food questionnairedietary habit enquiry and a 48h dietary | Other | Healthy control, Patient with Systemic Lupus Erythematosus, Patients with other autoimmune diseases |
| hairlock of hair | Other | Healthy control, Patient with Systemic Lupus Erythematosus, Patients with other autoimmune diseases |
Primary outcome
Quantification of different isoflavones and enterolactone
Time frame: At baseline (day 0)
in the blood and urine of patients and healthy controls
1 secondary outcome
Quantification of free estradiol concentrations
Time frame: At baseline (day 0)
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 14 May 2026.
- Results publication: PubMed 36079877Bensaada S, Raymond I, Breton M, Pellegrin I, Viallard JF, Bennetau-Pelissero C. Development of an Assay for Soy Isoflavones in Women's Hair. Nutrients. 2022 Sep 1;14(17):3619. doi: 10.3390/nu14173619.
- Results publication: PubMed 36839324Bensaada S, Raymond I, Pellegrin I, Viallard JF, Bennetau-Pelissero C. Validation of ELISAs for Isoflavones and Enterolactone for Phytoestrogen Intake Assessment in the French Population. Nutrients. 2023 Feb 15;15(4):967. doi: 10.3390/nu15040967.
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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.
Jean-François VIALLARD, Prof principal investigator
University Hospital, Bordeaux
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 sample, urine sample and food questionnaire in people with Lupus Erythematosus and Rheumatoid Arthritis, run by University Hospital, Bordeaux 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 13 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 14 May 2026. 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?
Quantification of different isoflavones and enterolactone (time frame: At baseline (day 0)). 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 NCT03421184, which also lists 2 linked publications.
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 14 May 2026.