Skip to content

Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03421184
Acronym
ISOLED
Enrollment
63
Registered
2018-02-05
Start date
2018-11-26
Completion date
2023-06-26
Last updated
2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus, Rheumatoid Arthritis, Autoimmune Thrombocytopenia

Keywords

autoimmune disease, endocrine disruptors, isoflavones, lignans, diet exposure, risk factor

Brief 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.

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.

Interventions

OTHERblood sample

25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

OTHERurine sample

10 ml

dietary habit enquiry and a 48h dietary

OTHERhair

lock of hair

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Quantification of different isoflavones and enterolactoneAt baseline (day 0)in the blood and urine of patients and healthy controls

Secondary

MeasureTime frameDescription
Quantification of free estradiol concentrationsAt baseline (day 0)in the blood and urine of patients and healthy controls

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026