Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus (ISOLED)

  • STATUS
    Recruiting
  • End date
    Dec 14, 2022
  • participants needed
    100
  • sponsor
    University Hospital, Bordeaux
Updated on 1 February 2022
autoimmune disease
lupus
Accepts healthy volunteers

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 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.

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.

Details
Condition Lupus Erythematosus, Rheumatoid Arthritis, Autoimmune Thrombocytopenia
Treatment Blood sample, Urine Sample, food questionnaire, hair, hair
Clinical Study IdentifierNCT03421184
SponsorUniversity Hospital, Bordeaux
Last Modified on1 February 2022

Eligibility

Yes No Not Sure

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
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