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

• ClinicalTrials.gov Identifier: NCT03421184
• Recruitment Status: Recruiting
• First Posted: February 5, 2018
• Last Update Posted: February 8, 2023
• Sponsor: University Hospital, Bordeaux
• Information provided by (Responsible Party): University Hospital, Bordeaux

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lupus Erythematosus; Rheumatoid Arthritis; Autoimmune Thrombocytopenia	Other: blood sample; Other: urine sample; Other: food questionnaire; Other: hair	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Dietary Phytoestrogens in Blood and Urine of Female Patient With Acute Systemic Lupus Erythematosus
• Actual Study Start Date: November 26, 2018
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Quantification of different isoflavones and enterolactone [ Time Frame: At baseline (day 0) ]
   in the blood and urine of patients and healthy controls

Secondary Outcome Measures :

1. Quantification of free estradiol concentrations [ Time Frame: At baseline (day 0) ]
   in the blood and urine of patients and healthy controls

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Jean-François VIALLARD, Prof; 05.57.65.64.83 ext +33; jean-françois.viallard@chu-bordeaux.fr

Contact: Isabelle RAYMOND, Pharm

Locations

France

CHU de Bordeaux - service de médecine interne; Recruiting

Pessac, France

Contact: Jean-François VIALLARD, Prof 05.57.65.64.83 ext +33 jean-françois.viallard@chu-bordeaux.fr

Contact: Isabelle RAYMOND, Pharm

Principal Investigator: Jean-François VIALLARD, Prof

Sub-Investigator: Estibaliz LAZARO, Prof

Sub-Investigator: Jean-Luc PELLEGRIN, Prof

Sub-Investigator: Carine GREIB, MD

Sub-Investigator: Irene MACHELARD, MD

Sub-Investigator: Marion MIRABEL, MD

Sub-Investigator: Etienne RIVIERE, MD

Sub-Investigator: Thierry SCHAEVERBEKE, Prof

Sub-Investigator: Christophe RICHEZ, Prof

Sub-Investigator: Marie-Elise TRUCHETET, MD

Sub-Investigator: Nicolas POURSAC, MD

Sub-Investigator: Nadia MEHSEN, MD

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

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

More Information

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT03421184
• Other Study ID Numbers: CHUBX 2017/18
• First Posted: February 5, 2018
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:

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

Additional relevant MeSH terms:

Thrombocytopenia; Immune System Diseases; Purpura, Thrombocytopenic, Idiopathic; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Blood Platelet Disorders; Hematologic Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Thrombotic Microangiopathies; Hemorrhagic Disorders; Hemorrhage; Pathologic Processes; Skin Manifestations