Methyl-donor Nutrient Supplementation and Methylation Profile in Lupus Patients With Obesity

April 30, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supplemented Normal Weight Group
Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive supplementation.
Dietary supplement: Vitamin B12 + folic acid supplementation
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 Excess Body Weight Group
Patients with excess body weight (BMI > 25 kg/m²) that will receive supplementation.
Dietary supplement: Vitamin B12 + folic acid supplementation
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 Normal Weight Group
Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive placebo.
Dietary supplement: Placebo supplementation
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 Excess Body Weight Group
Patients with excess body weight (BMI > 25 kg/m²) that will receive placebo.
Dietary supplement: Placebo supplementation
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 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 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 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
Change from baseline on TNF-a gene expression at 12 weeks
Time Frame: Baseline and 12 weeks
Relative gene expression of TNF-a
Baseline and 12 weeks
Change from baseline on LEP gene expression at 12 weeks
Time Frame: Baseline and 12 weeks
Relative gene expression of LEP
Baseline and 12 weeks
Change from baseline on ADIPOQ gene expression at 12 weeks
Time Frame: Baseline and 12 weeks
Relative gene expression of ADIPOQ
Baseline and 12 weeks
Change from baseline on MTHFR gene expression at 12 weeks
Time Frame: Baseline and 12 weeks
Relative gene expression of MTHFR
Baseline and 12 weeks
Change from baseline on STAT3 gene expression at 12 weeks
Time Frame: Baseline and 12 weeks
Relative gene expression of STAT3
Baseline and 12 weeks
Change from baseline on IL-6 gene expression at 12 weeks
Time Frame: Baseline and 12 weeks
Relative gene expression of IL-6
Baseline and 12 weeks
Change from baseline on serum IL-6 concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
Serum IL-6 concentration in ng/mL
Baseline and 12 weeks
Change from baseline on serum IL-17 concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
Serum IL-17 concentration in ng/mL
Baseline and 12 weeks
Change from baseline on serum IL-2 concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
Serum IL-2 concentration in ng/mL
Baseline and 12 weeks
Change from baseline on serum TNF-a concentrations at 12 weeks
Time Frame: Baseline and 12 weeks
Serum TNF-a concentration in ng/mL
Baseline and 12 weeks
Change from baseline on dietary intake at 12 weeks
Time Frame: Baseline and 12 weeks
Dietary intake in g and percentage
Baseline and 12 weeks
Change from baseline on fat free mass at 12 weeks
Time Frame: Baseline and 12 weeks
Fat free mass in kilograms
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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