Clinical trial NCT05097365: Methyl-donor Nutrient Supplementation and Methylation Profile in Lupus Patients With Obesity
Official title: Effect of Methyl-donor Nutrient Supplementation on Methylation Profile of Inflammatory-related Genes in Lupus Patients With Obesity: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Overweight and Obesity
Lupus Erythematosus
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion criteria:

* SLE diagnosis
* Female
* In pre-menopausal period
* Aged between 18 to 45 years
* Patients that meet the classification criteria according to Systemic Lupus International Collaborating Clinics classification criteria (SLICC)
* Patients with SLEDAI score ≤ 4 on Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
* Under prednisone treatment at a dosage \<10 mg/day
* Under treatment with chloroquine at a stable dose
* BMI \> 18,5 kg/m2

Exclusion Criteria:

* Current infection
* Diabetes
* Arterial hypertension
* Smokers
* Pregnancy
* Anticoagulants use
* Methotrexate use
* Other autoimmune diseases
* Current vitamin B12 or/and folic acid supplementation

Primary outcomes:
measure: Change from baseline on DNA methylation profile at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on weight at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum vitamin B12 concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum folic acid concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Age of onset
timeFrame: Baseline
measure: Duration of disease since diagnosis
timeFrame: Baseline
measure: Change from baseline on miR-146 expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on miR-181 expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on miR-21 expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on miR-126 expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on TNF-a gene expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on LEP gene expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on ADIPOQ gene expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on MTHFR gene expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on STAT3 gene expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on IL-6 gene expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on DNMT1 gene expression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum leptin concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum IL-6 concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum IL-17 concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum IL-2 concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum TNF-a concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum C-reactive protein concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum adipokines concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum triglycerides concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum cholesterol concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on serum glucose concentrations at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on dietary intake at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on abdominal circumference at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on fat mass at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on fat free mass at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on body mass index at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline on height at 12 weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Univsersity of Sao Paulo
Study officials:
References: