Methyl-donor Nutrient Supplementation and Methylation Profile in Lupus Patients With Obesity
- Conditions
- Overweight and ObesityLupus Erythematosus
- Interventions
- Dietary Supplement: Vitamin B12 + folic acid supplementationDietary Supplement: Placebo supplementation
- Registration Number
- NCT05097365
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
Dietary supplementation with methyl donors has been demonstrated to increase DNA methylation in leucocytes whereas a limited dietary intake of methyl donors was associated with DNA hypomethylation. Considering SLE disease, previously study showed that high doses of vitamin B6 and folate were associated with less severe SLE. Furthermore, some evidences reported a relatively high incidence of decreased serum B12 levels in rheumatic patients. This led to the suggestion that diets rich in methyl group donors could have beneficial effects on SLE.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 51
Not provided
- Current infection
- Diabetes
- Arterial hypertension
- Smokers
- Pregnancy
- Anticoagulants use
- Methotrexate use
- Other autoimmune diseases
- Current vitamin B12 or/and folic acid supplementation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supplemented Excess Body Weight Group Vitamin B12 + folic acid supplementation Patients with excess body weight (BMI \> 25 kg/m²) that will receive supplementation. Control Normal Weight Group Placebo supplementation Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive placebo. Control Excess Body Weight Group Placebo supplementation Patients with excess body weight (BMI \> 25 kg/m²) that will receive placebo. Supplemented Normal Weight Group Vitamin B12 + folic acid supplementation Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive supplementation.
- Primary Outcome Measures
Name Time Method Change from baseline on serum vitamin B12 concentrations at 12 weeks Baseline and 12 weeks Serum vitamin B12 concentrations in pg/mL
Change from baseline on DNA methylation profile at 12 weeks Baseline and 12 weeks Percentage of DNA methylation level
Change from baseline on weight at 12 weeks Baseline and 12 weeks Weight in kilograms
Change from baseline on serum folic acid concentrations at 12 weeks Baseline and 12 weeks Serum folic acid concentrations in ng/mL
- Secondary Outcome Measures
Name Time Method Change from baseline on fat free mass at 12 weeks Baseline and 12 weeks Fat free mass in kilograms
Change from baseline on STAT3 gene expression at 12 weeks Baseline and 12 weeks Relative gene expression of STAT3
Duration of disease since diagnosis Baseline Units of Measure: years
Change from baseline on miR-146 expression at 12 weeks Baseline and 12 weeks Relative miR-146 expression
Change from baseline on miR-181 expression at 12 weeks Baseline and 12 weeks Relative miR-181 expression
Change from baseline on miR-126 expression at 12 weeks Baseline and 12 weeks Relative miR-126 expression
Change from baseline on LEP gene expression at 12 weeks Baseline and 12 weeks Relative gene expression of LEP
Change from baseline on serum adipokines concentrations at 12 weeks Baseline and 12 weeks Serum adipokines concentration in ng/mL
Change from baseline on serum triglycerides concentrations at 12 weeks Baseline and 12 weeks Serum triglycerides concentration in mg/dL
Change from baseline on height at 12 weeks Baseline and 12 weeks Height in meters
Age of onset Baseline Units of Measure: years
Change from baseline on miR-21 expression at 12 weeks Baseline and 12 weeks Relative miR-21 expression
Change from baseline on TNF-a gene expression at 12 weeks Baseline and 12 weeks Relative gene expression of TNF-a
Change from baseline on ADIPOQ gene expression at 12 weeks Baseline and 12 weeks Relative gene expression of ADIPOQ
Change from baseline on MTHFR gene expression at 12 weeks Baseline and 12 weeks Relative gene expression of MTHFR
Change from baseline on IL-6 gene expression at 12 weeks Baseline and 12 weeks Relative gene expression of IL-6
Change from baseline on DNMT1 gene expression at 12 weeks Baseline and 12 weeks Relative gene expression of DNMT1
Change from baseline on serum leptin concentrations at 12 weeks Baseline and 12 weeks Serum leptin concentration in ng/mL
Change from baseline on serum IL-6 concentrations at 12 weeks Baseline and 12 weeks Serum IL-6 concentration in ng/mL
Change from baseline on serum IL-17 concentrations at 12 weeks Baseline and 12 weeks Serum IL-17 concentration in ng/mL
Change from baseline on serum IL-2 concentrations at 12 weeks Baseline and 12 weeks Serum IL-2 concentration in ng/mL
Change from baseline on serum C-reactive protein concentrations at 12 weeks Baseline and 12 weeks Serum C-reactive protein concentration in ng/mL
Change from baseline on serum cholesterol concentrations at 12 weeks Baseline and 12 weeks Serum cholesterol concentrations in mg/dL
Change from baseline on abdominal circumference at 12 weeks Baseline and 12 weeks Abdominal circumference in centimeters
Change from baseline on fat mass at 12 weeks Baseline and 12 weeks Fat mass in kilograms
Change from baseline on serum glucose concentrations at 12 weeks Baseline and 12 weeks Serum glucose concentrations in mg/dL
Change from baseline on dietary intake at 12 weeks Baseline and 12 weeks Dietary intake in g and percentage
Change from baseline on serum TNF-a concentrations at 12 weeks Baseline and 12 weeks Serum TNF-a concentration in ng/mL
Change from baseline on body mass index at 12 weeks Baseline and 12 weeks Body mass index in kilograms/meters\^2
Trial Locations
- Locations (1)
Univsersity of Sao Paulo
🇧🇷Sao Paulo, Brazil