Overweight and ObesityNCT05097365
Methyl-donor Nutrient Supplementation and Methylation Profile in Lupus Patients With Obesity
A study testing Vitamin B12 + folic acid supplementation in people with Overweight and Obesity and Lupus Erythematosus, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Overweight and Obesity, Lupus Erythematosus
- What is being tested?
- Vitamin B12 + folic acid supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 9Show fewer
- Under prednisone treatment at a dosage <10 mg/day
- Under treatment with chloroquine at a stable dose
- BMI > 18,5 kg/m2
Who cannot join
- Current infection
- Diabetes
- Arterial hypertension
- Smokers
- Pregnancy
- Anticoagulants use
Show all 9Show fewer
- Methotrexate use
- Other autoimmune diseases
- Current vitamin B12 or/and folic acid supplementation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Overweight and Obesity, Lupus Erythematosus
- Being tested
- Vitamin B12 + folic acid supplementation, Placebo supplementation
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12 + folic acid supplementationDietary supplement
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 supplementationDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Supplemented Normal Weight Group | Experimental | Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive supplementation. Receives: Dietary Supplement: Vitamin B12 + folic acid supplementation |
| Supplemented Excess Body Weight Group | Experimental | Patients with excess body weight (BMI > 25 kg/m²) that will receive supplementation. Receives: Dietary Supplement: Vitamin B12 + folic acid supplementation |
| Control Normal Weight Group | Placebo comparator | Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive placebo. Receives: Dietary Supplement: Placebo supplementation |
| Control Excess Body Weight Group | Placebo comparator | Patients with excess body weight (BMI > 25 kg/m²) that will receive placebo. Receives: Dietary Supplement: Placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on DNA methylation profile at 12 weeks
Percentage of DNA methylation level
Measured: Baseline and 12 weeks
Change from baseline on weight at 12 weeks
Weight in kilograms
Measured: Baseline and 12 weeks
Change from baseline on serum vitamin B12 concentrations at 12 weeks
Serum vitamin B12 concentrations in pg/mL
Measured: Baseline and 12 weeks
Change from baseline on serum folic acid concentrations at 12 weeks
Serum folic acid concentrations in ng/mL
Measured: Baseline and 12 weeks
Secondary outcomes (29)
Age of onset
Units of Measure: years
Measured: Baseline
Duration of disease since diagnosis
Units of Measure: years
Measured: Baseline
Change from baseline on miR-146 expression at 12 weeks
Relative miR-146 expression
Measured: Baseline and 12 weeks
Change from baseline on miR-181 expression at 12 weeks
Relative miR-181 expression
Measured: Baseline and 12 weeks
Change from baseline on miR-21 expression at 12 weeks
Relative miR-21 expression
Measured: Baseline and 12 weeks
Change from baseline on miR-126 expression at 12 weeks
Relative miR-126 expression
Measured: Baseline and 12 weeks
Change from baseline on TNF-a gene expression at 12 weeks
Relative gene expression of TNF-a
Measured: Baseline and 12 weeks
Change from baseline on LEP gene expression at 12 weeks
Relative gene expression of LEP
Measured: Baseline and 12 weeks
Change from baseline on ADIPOQ gene expression at 12 weeks
Relative gene expression of ADIPOQ
Measured: Baseline and 12 weeks
Change from baseline on MTHFR gene expression at 12 weeks
Relative gene expression of MTHFR
Measured: Baseline and 12 weeks
Change from baseline on STAT3 gene expression at 12 weeks
Relative gene expression of STAT3
Measured: Baseline and 12 weeks
Change from baseline on IL-6 gene expression at 12 weeks
Relative gene expression of IL-6
Measured: Baseline and 12 weeks
Change from baseline on DNMT1 gene expression at 12 weeks
Relative gene expression of DNMT1
Measured: Baseline and 12 weeks
Change from baseline on serum leptin concentrations at 12 weeks
Serum leptin concentration in ng/mL
Measured: Baseline and 12 weeks
Change from baseline on serum IL-6 concentrations at 12 weeks
Serum IL-6 concentration in ng/mL
Measured: Baseline and 12 weeks
Change from baseline on serum IL-17 concentrations at 12 weeks
Serum IL-17 concentration in ng/mL
Measured: Baseline and 12 weeks
Change from baseline on serum IL-2 concentrations at 12 weeks
Serum IL-2 concentration in ng/mL
Measured: Baseline and 12 weeks
Change from baseline on serum TNF-a concentrations at 12 weeks
Serum TNF-a concentration in ng/mL
Measured: Baseline and 12 weeks
Change from baseline on serum C-reactive protein concentrations at 12 weeks
Serum C-reactive protein concentration in ng/mL
Measured: Baseline and 12 weeks
Change from baseline on serum adipokines concentrations at 12 weeks
Serum adipokines concentration in ng/mL
Measured: Baseline and 12 weeks
Change from baseline on serum triglycerides concentrations at 12 weeks
Serum triglycerides concentration in mg/dL
Measured: Baseline and 12 weeks
Change from baseline on serum cholesterol concentrations at 12 weeks
Serum cholesterol concentrations in mg/dL
Measured: Baseline and 12 weeks
Change from baseline on serum glucose concentrations at 12 weeks
Serum glucose concentrations in mg/dL
Measured: Baseline and 12 weeks
Change from baseline on dietary intake at 12 weeks
Dietary intake in g and percentage
Measured: Baseline and 12 weeks
Change from baseline on abdominal circumference at 12 weeks
Abdominal circumference in centimeters
Measured: Baseline and 12 weeks
Change from baseline on fat mass at 12 weeks
Fat mass in kilograms
Measured: Baseline and 12 weeks
Change from baseline on fat free mass at 12 weeks
Fat free mass in kilograms
Measured: Baseline and 12 weeks
Change from baseline on body mass index at 12 weeks
Body mass index in kilograms/meters^2
Measured: Baseline and 12 weeks
Change from baseline on height at 12 weeks
Height in meters
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Jan 2022
- Primary completion31 Jul 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097365
- Sponsor's protocol ID
- SLE and DNA methylation
- Status last verified
- Apr 2024
- First submitted
- 10 Aug 2021
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carvalho LM, da Mota JCNL, Ribeiro AA, Souza LL, Sposeto RB, Pinhel MAS, Nonino CB, Costa-Fraga N, Crujeiras AB, Izquierdo AG, Diaz-Lagares A, Hounkpe BW, Borba EF, Gualano B, Nicoletti CF. Epigenetic and metabolic signatures in systemic lupus erythematous: The impact of excess body weight on adipose tissue DNA methylation profile. Genomics. 2026 Mar;118(2):111217. doi: 10.1016/j.ygeno.2026.111217. Epub 2026 Feb 8.
PubMed 41666998da Mota JCNL, Carvalho LM, Souza LL, Ribeiro AA, Pinhel MAS, Nonino CB, Godoy AL, Borba EF, Hounkpe BW, Gualano B, Nicoletti CF. Nutritional status-dependent DNA methylation modifications on adipose tissue in systemic lupus erythematosus women following folic acid and vitamin B12 supplementation: a randomized double-blind placebo-controlled trial. Clin Epigenetics. 2026 Jan 3;18(1):21. doi: 10.1186/s13148-025-02041-5.
PubMed 41484640da Mota JCNL, Carvalho LM, Ribeiro AA, Souza LL, Borba EF, Roschel H, Gualano B, Nicoletti CF. Methyl-donor supplementation in women with systemic lupus erythematosus with different nutritional status: the protocol for a randomised, double-blind, placebo-controlled trial. Lupus Sci Med. 2024 Oct 7;11(2):e001279. doi: 10.1136/lupus-2024-001279.
PubMed 39375179
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Methyl-donor Nutrient Supplementation on Methylation Profile of Inflammatory-related Genes in Lupus Patients With Obesity: a Clinical Trial
- ClinicalTrials.gov ID
- NCT05097365
- Acronym / sponsor ID
- SLE and DNA methylation
- Conditions
- Overweight and Obesity, Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supplemented Normal Weight Group | Experimental | Dietary Supplement: Vitamin B12 + folic acid supplementationPatients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive supplementation. |
| Supplemented Excess Body Weight Group | Experimental | Dietary Supplement: Vitamin B12 + folic acid supplementationPatients with excess body weight (BMI > 25 kg/m²) that will receive supplementation. |
| Control Normal Weight Group | Placebo comparator | Dietary Supplement: Placebo supplementationPatients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive placebo. |
| Control Excess Body Weight Group | Placebo comparator | Dietary Supplement: Placebo supplementationPatients with excess body weight (BMI > 25 kg/m²) that will receive placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- Current infection
- Diabetes
- Arterial hypertension
- Smokers
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B12 + folic acid supplementationA 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. | Dietary supplement | Supplemented Excess Body Weight Group, Supplemented Normal Weight Group |
| Placebo supplementationA 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. | Dietary supplement | Control Excess Body Weight Group, Control Normal Weight Group |
Primary outcome
Change from baseline on DNA methylation profile at 12 weeks
Time frame: Baseline and 12 weeks
Percentage of DNA methylation level
Change from baseline on weight at 12 weeks
Time frame: Baseline and 12 weeks
Weight in kilograms
Change from baseline on serum vitamin B12 concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Serum vitamin B12 concentrations in pg/mL
Change from baseline on serum folic acid concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Serum folic acid concentrations in ng/mL
29 secondary outcomes
Age of onset
Time frame: Baseline
Duration of disease since diagnosis
Time frame: Baseline
Change from baseline on miR-146 expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on miR-181 expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on miR-21 expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on miR-126 expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on TNF-a gene expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on LEP gene expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on ADIPOQ gene expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on MTHFR gene expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on STAT3 gene expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on IL-6 gene expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on DNMT1 gene expression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum leptin concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum IL-6 concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum IL-17 concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum IL-2 concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum TNF-a concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum C-reactive protein concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum adipokines concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum triglycerides concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum cholesterol concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on serum glucose concentrations at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on dietary intake at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on abdominal circumference at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on fat mass at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on fat free mass at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on body mass index at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline on height at 12 weeks
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Derived from this study: PubMed 41666998Carvalho LM, da Mota JCNL, Ribeiro AA, Souza LL, Sposeto RB, Pinhel MAS, Nonino CB, Costa-Fraga N, Crujeiras AB, Izquierdo AG, Diaz-Lagares A, Hounkpe BW, Borba EF, Gualano B, Nicoletti CF. Epigenetic and metabolic signatures in systemic lupus erythematous: The impact of excess body weight on adipose tissue DNA methylation profile. Genomics. 2026 Mar;118(2):111217. doi: 10.1016/j.ygeno.2026.111217. Epub 2026 Feb 8.
- Derived from this study: PubMed 41484640da Mota JCNL, Carvalho LM, Souza LL, Ribeiro AA, Pinhel MAS, Nonino CB, Godoy AL, Borba EF, Hounkpe BW, Gualano B, Nicoletti CF. Nutritional status-dependent DNA methylation modifications on adipose tissue in systemic lupus erythematosus women following folic acid and vitamin B12 supplementation: a randomized double-blind placebo-controlled trial. Clin Epigenetics. 2026 Jan 3;18(1):21. doi: 10.1186/s13148-025-02041-5.
- Derived from this study: PubMed 39375179da Mota JCNL, Carvalho LM, Ribeiro AA, Souza LL, Borba EF, Roschel H, Gualano B, Nicoletti CF. Methyl-donor supplementation in women with systemic lupus erythematosus with different nutritional status: the protocol for a randomised, double-blind, placebo-controlled trial. Lupus Sci Med. 2024 Oct 7;11(2):e001279. doi: 10.1136/lupus-2024-001279.
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B12 + folic acid supplementation in people with Overweight and Obesity and Lupus Erythematosus, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on DNA methylation profile at 12 weeks (time frame: Baseline and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05097365, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.