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

Primary Purpose

Obesity, Lupus Erythematosus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Vitamin B12 + folic acid supplementation
Placebo supplementation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

- 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

Sites / Locations

  • Univsersity of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Supplemented Lean Group

Supplemented Obese Group

Control Lean Group

Control Obese Group

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline on DNA methylation profile at 12 weeks
Percentage of DNA methylation level
Change from baseline on weight at 12 weeks
Weight in kilograms
Change from baseline on serum vitamin B12 concentrations at 12 weeks
Serum vitamin B12 concentrations in pg/mL
Change from baseline on serum folic acid concentrations at 12 weeks
Serum folic acid concentrations in ng/mL

Secondary Outcome Measures

Age of onset
Units of Measure: years
Duration of disease since diagnosis
Units of Measure: years
Change from baseline on miR-146 expression at 12 weeks
Relative miR-146 expression
Change from baseline on miR-181 expression at 12 weeks
Relative miR-181 expression
Change from baseline on miR-21 expression at 12 weeks
Relative miR-21 expression
Change from baseline on miR-126 expression at 12 weeks
Relative miR-126 expression
Change from baseline on DNMT3 gene expression at 12 weeks
Relative gene expression of DNMT3
Change from baseline on DNMT1 gene expression at 12 weeks
Relative gene expression of DNMT1
Change from baseline on global DNA hydroxymethylation at 12 weeks
Percentage of global DNA hydroxymethylation level
Change from baseline on serum leptin concentrations at 12 weeks
Serum leptin concentration in ng/mL
Change from baseline on serum C-reactive protein concentrations at 12 weeks
Serum C-reactive protein concentration in ng/mL
Change from baseline on serum adipokines concentrations at 12 weeks
Serum adipokines concentration in ng/mL
Change from baseline on serum triglycerides concentrations at 12 weeks
Serum triglycerides concentration in mg/dL
Change from baseline on serum cholesterol concentrations at 12 weeks
Serum cholesterol concentrations in mg/dL
Change from baseline on serum glucose concentrations at 12 weeks
Serum glucose concentrations in mg/dL
Change from baseline on dietary intake at 12 weeks
Change from baseline on abdominal circumference at 12 weeks
Abdominal circumference in centimeters
Change from baseline on fat mass at 12 weeks
Fat mass in kilograms
Change from baseline on body mass index at 12 weeks
Body mass index in kilograms/meters^2
Change from baseline on height at 12 weeks
Height in meters

Full Information

First Posted
August 10, 2021
Last Updated
October 15, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05097365
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Lupus Erythematosus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supplemented Lean Group
Arm Type
Experimental
Arm Title
Supplemented Obese Group
Arm Type
Experimental
Arm Title
Control Lean Group
Arm Type
Placebo Comparator
Arm Title
Control Obese Group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin B12 + folic acid supplementation
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline on DNA methylation profile at 12 weeks
Description
Percentage of DNA methylation level
Time Frame
Baseline and 12 weeks
Title
Change from baseline on weight at 12 weeks
Description
Weight in kilograms
Time Frame
Baseline and 12 weeks
Title
Change from baseline on serum vitamin B12 concentrations at 12 weeks
Description
Serum vitamin B12 concentrations in pg/mL
Time Frame
Baseline and 12 weeks
Title
Change from baseline on serum folic acid concentrations at 12 weeks
Description
Serum folic acid concentrations in ng/mL
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Age of onset
Description
Units of Measure: years
Time Frame
Baseline
Title
Duration of disease since diagnosis
Description
Units of Measure: years
Time Frame
Baseline
Title
Change from baseline on miR-146 expression at 12 weeks
Description
Relative miR-146 expression
Time Frame
Baseline and 12 weeks
Title
Change from baseline on miR-181 expression at 12 weeks
Description
Relative miR-181 expression
Time Frame
Baseline and 12 weeks
Title
Change from baseline on miR-21 expression at 12 weeks
Description
Relative miR-21 expression
Time Frame
Baseline and 12 weeks
Title
Change from baseline on miR-126 expression at 12 weeks
Description
Relative miR-126 expression
Time Frame
Baseline and 12 weeks
Title
Change from baseline on DNMT3 gene expression at 12 weeks
Description
Relative gene expression of DNMT3
Time Frame
Baseline and 12 weeks
Title
Change from baseline on DNMT1 gene expression at 12 weeks
Description
Relative gene expression of DNMT1
Time Frame
Baseline and 12 weeks
Title
Change from baseline on global DNA hydroxymethylation at 12 weeks
Description
Percentage of global DNA hydroxymethylation level
Time Frame
Baseline and 12 weeks
Title
Change from baseline on serum leptin concentrations at 12 weeks
Description
Serum leptin concentration in ng/mL
Time Frame
Baseline and 12 weeks
Title
Change from baseline on serum C-reactive protein concentrations at 12 weeks
Description
Serum C-reactive protein concentration in ng/mL
Time Frame
Baseline and 12 weeks
Title
Change from baseline on serum adipokines concentrations at 12 weeks
Description
Serum adipokines concentration in ng/mL
Time Frame
Baseline and 12 weeks
Title
Change from baseline on serum triglycerides concentrations at 12 weeks
Description
Serum triglycerides concentration in mg/dL
Time Frame
Baseline and 12 weeks
Title
Change from baseline on serum cholesterol concentrations at 12 weeks
Description
Serum cholesterol concentrations in mg/dL
Time Frame
Baseline and 12 weeks
Title
Change from baseline on serum glucose concentrations at 12 weeks
Description
Serum glucose concentrations in mg/dL
Time Frame
Baseline and 12 weeks
Title
Change from baseline on dietary intake at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change from baseline on abdominal circumference at 12 weeks
Description
Abdominal circumference in centimeters
Time Frame
Baseline and 12 weeks
Title
Change from baseline on fat mass at 12 weeks
Description
Fat mass in kilograms
Time Frame
Baseline and 12 weeks
Title
Change from baseline on body mass index at 12 weeks
Description
Body mass index in kilograms/meters^2
Time Frame
Baseline and 12 weeks
Title
Change from baseline on height at 12 weeks
Description
Height in meters
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
- 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
Facility Information:
Facility Name
Univsersity of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-030
Country
Brazil

12. IPD Sharing Statement

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

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