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

July 6, 2023 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France
        • CHU de Bordeaux - service de médecine interne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Jean-François VIALLARD, Prof, CHU Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2018

Primary Completion (Actual)

June 26, 2023

Study Completion (Actual)

June 26, 2023

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2017/18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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