Systemic Lupus Erythematosus Clinical Trial
Official title:
The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity
The study investigates the dietary habits in relation to low doses of omega-3 fatty acids in subcutaneous adipose tissue, disease activity and atherosclerosis. The low intake of omega-3 and high intake of carbohydrate among patients with SLE appear to be associated with worse disease activity, adverse serum lipids and plaque presence.Three-month-old mice received an injection of pristane or saline solution and were fed with different experimental diets: sunflower oil diet or extra virgin olive oil (EVOO) diet. After 24 weeks, mice were sacrificed, spleens were collected and kidneys were removed for immunoinflammatory detections. The study have demonstrated that EVOO diet significantly reduced renal damage and decreased cytokine: TNF-α, IL-6, IL-10 and IL-17 production.The ketogenic diet utilizes a high fat, adequate protein, low carbohydrate diet that control type of food and exchange. The aim of the present study that ketogenic diet treated in SLE patients may decrease overactive immunity and associated inflammatory markers.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 2024 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: 1. more than 20 years old 2. can accept these dietary intervention and fill out the consent 3. Satisfy at least four criteria according to 1997 American College of Rheumatology Classification Criteria 4. Under maintenance stage of disease and have more than 1gm of daily proteinuria. Exclusion Criteria: 1. Can't cooperate the diet intervention 2. Rapid progression of renal function, or already need renal replacement therapy (Dialysis or kidney transplantation) |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung memorial hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | urine albumin creatinine ratio | By using urine albumin creatinine ratio to determine whether the ketogenic diet could result in less proteinuria | 8 times: Day1, 1st week, 1st month, 2nd month during ketogenic diet then Day1, 1st week, 1st month, 2nd month during balanced diet | |
Primary | Change in Inflammatory cytokine | By testing blood inflammatory cytokine: TNF-a, IL-6, IL-10 and IL-17 to evaluate whether the ketogenic diet could decrease systemic inflammation | 8 times: Day1, 1st week, 1st month, 2nd month during ketogenic diet then Day1, 1st week, 1st month, 2nd month during balanced diet | |
Secondary | Change of subclass of T cells | By using flow cytometry to detect the change of subclasses of blood T cells after ketogenic diet | 2 times: 2nd month during ketogenic diet then 2nd month during balanced diet | |
Secondary | Change of Gut microbiota analysis | By using new generation sequencing to detect the change of gut microbiota after ketogenicdiet | 2 times: 2nd month during ketogenic diet then 2nd month during balanced diet |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03843125 -
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
|
Phase 3 | |
Recruiting |
NCT05698173 -
Systemic Lupus Erythematosus and Accelerated Aging
|
N/A | |
Active, not recruiting |
NCT01649765 -
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
|
Phase 2 | |
Recruiting |
NCT05704153 -
Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
|
N/A | |
Completed |
NCT05048238 -
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
|
Phase 1 | |
Recruiting |
NCT06056778 -
The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
|
||
Completed |
NCT04358302 -
Individual Patient Exposure and Response in Pediatric Lupus
|
N/A | |
Completed |
NCT03802578 -
The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients
|
N/A | |
Completed |
NCT02554019 -
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
|
Phase 2 | |
Recruiting |
NCT04835883 -
Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients
|
Phase 2 | |
Terminated |
NCT02665364 -
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
|
Phase 2 | |
Completed |
NCT00278538 -
Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus
|
Phase 2 | |
Completed |
NCT00069342 -
Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
|
||
Completed |
NCT03252587 -
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
|
Phase 2 | |
Terminated |
NCT02066311 -
Nelfinavir in Systemic Lupus Erythematosus
|
Phase 2 | |
Recruiting |
NCT01892748 -
Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
|
N/A | |
Terminated |
NCT01689025 -
An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
|
Phase 1 | |
Completed |
NCT01475149 -
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
|
N/A | |
Unknown status |
NCT01712529 -
Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
|
N/A | |
Completed |
NCT00962832 -
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
|
Phase 2 |