Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus (ISOLED)
Primary Purpose
Lupus Erythematosus, Rheumatoid Arthritis, Autoimmune Thrombocytopenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
urine sample
food questionnaire
hair
Sponsored by
About this trial
This is an interventional other trial for Lupus Erythematosus focused on measuring autoimmune disease, endocrine disruptors, isoflavones, lignans, diet exposure, risk factor
Eligibility 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.
Sites / Locations
- CHU de Bordeaux - service de médecine interne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Patient with Systemic Lupus Erythematosus
Patients with other autoimmune diseases
Healthy control
Arm Description
30 women with SLE
20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia
30 healthy control women
Outcomes
Primary Outcome Measures
Quantification of different isoflavones and enterolactone
in the blood and urine of patients and healthy controls
Secondary Outcome Measures
Quantification of free estradiol concentrations
in the blood and urine of patients and healthy controls
Full Information
NCT ID
NCT03421184
First Posted
January 29, 2018
Last Updated
July 6, 2023
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT03421184
Brief Title
Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus
Acronym
ISOLED
Official Title
Dietary Phytoestrogens in Blood and Urine of Female Patient With Acute Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
June 26, 2023 (Actual)
Study Completion Date
June 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Rheumatoid Arthritis, Autoimmune Thrombocytopenia
Keywords
autoimmune disease, endocrine disruptors, isoflavones, lignans, diet exposure, risk factor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with Systemic Lupus Erythematosus
Arm Type
Experimental
Arm Description
30 women with SLE
Arm Title
Patients with other autoimmune diseases
Arm Type
Active Comparator
Arm Description
20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia
Arm Title
Healthy control
Arm Type
Active Comparator
Arm Description
30 healthy control women
Intervention Type
Other
Intervention Name(s)
blood sample
Intervention Description
25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Intervention Type
Other
Intervention Name(s)
urine sample
Intervention Description
10 ml
Intervention Type
Other
Intervention Name(s)
food questionnaire
Intervention Description
dietary habit enquiry and a 48h dietary
Intervention Type
Other
Intervention Name(s)
hair
Intervention Description
lock of hair
Primary Outcome Measure Information:
Title
Quantification of different isoflavones and enterolactone
Description
in the blood and urine of patients and healthy controls
Time Frame
At baseline (day 0)
Secondary Outcome Measure Information:
Title
Quantification of free estradiol concentrations
Description
in the blood and urine of patients and healthy controls
Time Frame
At baseline (day 0)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François VIALLARD, Prof
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux - service de médecine interne
City
Pessac
Country
France
12. IPD Sharing Statement
Learn more about this trial
Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus
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