Skip to main content
OpenTrials
Completed

NCT Number: NCT03421184

Dietary Phytoestrogens as Risk Factors for 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

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

Urine sample

Other

10 ml

food questionnaire

Other

dietary habit enquiry and a 48h dietary

hair

Other

lock of hair

Primary outcomes

  1. Quantification of different isoflavones and enterolactone

    Time frame: At baseline (day 0)

    in the blood and urine of patients and healthy controls

Secondary outcomes

  1. Quantification of free estradiol concentrations

    Time frame: At baseline (day 0)

    in the blood and urine of patients and healthy controls

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: ISOLED

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2018
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.