The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity

NCT05689580 | Unknown DMC

• 1 other identifier: 202001487A3C102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus; Ketogenic Dieting

Outcome Measures

Primary Outcomes (2)

• 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

• Change in Inflammatory cytokine

  By testing blood inflammatory cytokine: TNF-α, 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 Outcomes (2)

• Change of subclass of T cells

  2 times: 2nd month during ketogenic diet then 2nd month during balanced diet

• Change of Gut microbiota analysis

  2 times: 2nd month during ketogenic diet then 2nd month during balanced diet

Study Arms (2)

Patients received ketogenic diet then Balanced diet

EXPERIMENTAL

subjects will be educated by dietitian and receive two months of ketogenic diet. Then, followed by three months of washout period. Finally, they will receive dietary education and follow balanced diet for two months.

Dietary Supplement: Ketogenic diet; Dietary Supplement: Balanced diet

Patients received Balanced diet then ketogenic diet

EXPERIMENTAL

subjects will receive dietary education and follow balanced diet for two months first, then followed by three months of washout period. At last, they will receive dietary education of ketogenic diet and need to follow the ketogenic diet for two months.

Dietary Supplement: Ketogenic diet; Dietary Supplement: Balanced diet

Interventions

Ketogenic diet DIETARY_SUPPLEMENT

The course of the trial to medium-chain triglyceride lipid intervening 50-70% of dietary intake

Patients received Balanced diet then ketogenic diet; Patients received ketogenic diet then Balanced diet

Balanced diet DIETARY_SUPPLEMENT

Balanced diet

Patients received Balanced diet then ketogenic diet; Patients received ketogenic diet then Balanced diet

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• more than 20 years old
• can accept these dietary intervention and fill out the consent
• Satisfy at least four criteria according to 1997 American College of Rheumatology Classification Criteria
• Under maintenance stage of disease and have more than 1gm of daily proteinuria.

You may not qualify if:

• Can't cooperate the diet intervention
• Rapid progression of renal function, or already need renal replacement therapy (Dialysis or kidney transplantation)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung memorial hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Chieh-Li Yen, MD

CONTACT

+886975367240; b9102087@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For Group 1, subjects will be educated by dietitian and receive two months of ketogenic diet. Then, followed by three months of washout period. Finally, they will receive dietary education and follow balanced diet for two months. For Group2, subjects will receive dietary education and follow balanced diet for two months first, then followed by three months of washout period. At last, they will receive dietary education of ketogenic diet and need to follow the ketogenic diet for two months.

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: January 19, 2023

Record last verified: 2022-09

Locations

TW (1)