- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05097365
Methyl-donor Nutrient Supplementation and Methylation Profile in Lupus Patients With Obesity
October 15, 2021 updated by: Bruno Gualano, University of Sao Paulo
Effect of Methyl-donor Nutrient Supplementation on Methylation Profile of Inflammatory-related Genes in Lupus Patients With Obesity: a Clinical Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
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
-
-
-
Sao Paulo, Brazil, 05508-030
- Univsersity of Sao Paulo
-
-
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 to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
- Female
Inclusion criteria:
- In pre-menopausal period
- Aged between 18 to 40 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 glucocorticoid treatment at a dosage <10 mg/day
- Under treatment with chloroquine at a stable dose
Exclusion Criteria:
- Infection
- Diabetes
- Smokers
- Pregnancy
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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Supplemented Lean Group
|
A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a vitamin B12 and folic acid supplementation, in addition to the usual therapy.
The dietary supplementation will be by capsules, which will content 400 mcg of folic acid and 2000 mcg of vitamin B12 each.
|
EXPERIMENTAL: Supplemented Obese Group
|
A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a vitamin B12 and folic acid supplementation, in addition to the usual therapy.
The dietary supplementation will be by capsules, which will content 400 mcg of folic acid and 2000 mcg of vitamin B12 each.
|
PLACEBO_COMPARATOR: Control Lean Group
|
A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a placebo supplementation.The placebo and vitamin B12 + folic acid supplement will be indistinguishable in terms of taste, smell, and appearance.
|
PLACEBO_COMPARATOR: Control Obese Group
|
A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a placebo supplementation.The placebo and vitamin B12 + folic acid supplement will be indistinguishable in terms of taste, smell, and appearance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline on DNA methylation profile at 12 weeks
Time Frame: Baseline and 12 weeks
|
Percentage of DNA methylation level
|
Baseline and 12 weeks
|
Change from baseline on weight at 12 weeks
Time Frame: Baseline and 12 weeks
|
Weight in kilograms
|
Baseline and 12 weeks
|
Change from baseline on serum vitamin B12 concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
|
Serum vitamin B12 concentrations in pg/mL
|
Baseline and 12 weeks
|
Change from baseline on serum folic acid concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
|
Serum folic acid concentrations in ng/mL
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age of onset
Time Frame: Baseline
|
Units of Measure: years
|
Baseline
|
Duration of disease since diagnosis
Time Frame: Baseline
|
Units of Measure: years
|
Baseline
|
Change from baseline on miR-146 expression at 12 weeks
Time Frame: Baseline and 12 weeks
|
Relative miR-146 expression
|
Baseline and 12 weeks
|
Change from baseline on miR-181 expression at 12 weeks
Time Frame: Baseline and 12 weeks
|
Relative miR-181 expression
|
Baseline and 12 weeks
|
Change from baseline on miR-21 expression at 12 weeks
Time Frame: Baseline and 12 weeks
|
Relative miR-21 expression
|
Baseline and 12 weeks
|
Change from baseline on miR-126 expression at 12 weeks
Time Frame: Baseline and 12 weeks
|
Relative miR-126 expression
|
Baseline and 12 weeks
|
Change from baseline on DNMT3 gene expression at 12 weeks
Time Frame: Baseline and 12 weeks
|
Relative gene expression of DNMT3
|
Baseline and 12 weeks
|
Change from baseline on DNMT1 gene expression at 12 weeks
Time Frame: Baseline and 12 weeks
|
Relative gene expression of DNMT1
|
Baseline and 12 weeks
|
Change from baseline on global DNA hydroxymethylation at 12 weeks
Time Frame: Baseline and 12 weeks
|
Percentage of global DNA hydroxymethylation level
|
Baseline and 12 weeks
|
Change from baseline on serum leptin concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
|
Serum leptin concentration in ng/mL
|
Baseline and 12 weeks
|
Change from baseline on serum C-reactive protein concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
|
Serum C-reactive protein concentration in ng/mL
|
Baseline and 12 weeks
|
Change from baseline on serum adipokines concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
|
Serum adipokines concentration in ng/mL
|
Baseline and 12 weeks
|
Change from baseline on serum triglycerides concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
|
Serum triglycerides concentration in mg/dL
|
Baseline and 12 weeks
|
Change from baseline on serum cholesterol concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
|
Serum cholesterol concentrations in mg/dL
|
Baseline and 12 weeks
|
Change from baseline on serum glucose concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
|
Serum glucose concentrations in mg/dL
|
Baseline and 12 weeks
|
Change from baseline on dietary intake at 12 weeks
Time Frame: Baseline and 12 weeks
|
Baseline and 12 weeks
|
|
Change from baseline on abdominal circumference at 12 weeks
Time Frame: Baseline and 12 weeks
|
Abdominal circumference in centimeters
|
Baseline and 12 weeks
|
Change from baseline on fat mass at 12 weeks
Time Frame: Baseline and 12 weeks
|
Fat mass in kilograms
|
Baseline and 12 weeks
|
Change from baseline on body mass index at 12 weeks
Time Frame: Baseline and 12 weeks
|
Body mass index in kilograms/meters^2
|
Baseline and 12 weeks
|
Change from baseline on height at 12 weeks
Time Frame: Baseline and 12 weeks
|
Height in meters
|
Baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
January 1, 2022
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
December 31, 2026
Study Registration Dates
First Submitted
August 10, 2021
First Submitted That Met QC Criteria
October 15, 2021
First Posted (ACTUAL)
October 28, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 15, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLE and DNA methylation
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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