Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dietary Phytoestrogens in Blood and Urine of Female Patient With Acute Systemic Lupus Erythematosus

Conditions
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Lupus Erythematosus, Rheumatoid Arthritis, Autoimmune Thrombocytopenia

Intervention / Treatment
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* Other: blood sample
* Other: urine sample
* Other: food questionnaire
* Other: hair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 : 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. Exclusion Criteria: 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 : HIV, HCV or HBV sero-positivity; pregnant or lactating women; menopausal women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with Systemic Lupus Erythematosus<br>30 women with SLE | Other: blood sample<br>* 25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation<br>Other: urine sample<br>* 10 ml<br>Other: food questionnaire<br>* dietary habit enquiry and a 48h dietary<br>Other: hair<br>* lock of hair<br>|
| Active Comparator: Patients with other autoimmune diseases<br>20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia | Other: blood sample<br>* 25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation<br>Other: urine sample<br>* 10 ml<br>Other: food questionnaire<br>* dietary habit enquiry and a 48h dietary<br>Other: hair<br>* lock of hair<br>|
| Active Comparator: Healthy control<br>30 healthy control women | Other: blood sample<br>* 25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation<br>Other: urine sample<br>* 10 ml<br>Other: food questionnaire<br>* dietary habit enquiry and a 48h dietary<br>Other: hair<br>* lock of hair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of different isoflavones and enterolactone | in the blood and urine of patients and healthy controls | At baseline (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of free estradiol concentrations | in the blood and urine of patients and healthy controls | At baseline (day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lignans, autoimmune disease, endocrine disruptors, isoflavones, diet exposure, risk factor