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The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity

Primary Purpose

Systemic Lupus Erythematosus, Ketogenic Dieting

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ketogenic diet
Balanced diet
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Can't cooperate the diet intervention Rapid progression of renal function, or already need renal replacement therapy (Dialysis or kidney transplantation)

Sites / Locations

  • Chang Gung memorial hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients received ketogenic diet then Balanced diet

Patients received Balanced diet then ketogenic diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

urine albumin creatinine ratio
By using urine albumin creatinine ratio to determine whether the ketogenic diet could result in less proteinuria
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

Secondary Outcome Measures

Change of subclass of T cells
By using flow cytometry to detect the change of subclasses of blood T cells after ketogenic diet
Change of Gut microbiota analysis
By using new generation sequencing to detect the change of gut microbiota after ketogenicdiet

Full Information

First Posted
January 10, 2023
Last Updated
January 18, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05689580
Brief Title
The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity
Official Title
The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study was conducted in patients with lupus nephritis at outpatient department, who are 1.more than 20 years old, 2. can accept these dietary intervention and fill out 《20200909 version4》 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. These enrollees will be assigned into two groups randomly. 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. During the Ketogenic diet (2months) and balanced diet (2months) period, subjects were separately assessed with nutritional status evaluation and laboratory data follow-up for 4 times (Day1, 1st week, 1st month, 2nd month). During the 8 times visits , anthropometric, age, sex, height, weight, BMI, muscle girdle measurements, biochemical measurements, serum albumin, blood urea nitrogen, hemoglobin, and electrolyte, nitrogen balance, and medical records are evaluated. The course of the trial to medium-chain triglyceride lipid intervening 50-70% of dietary intake, the first day of consumption of 1/3 amount of medium chain fat, if no adverse adaptation, an increase of 1/3 volume until the full amount of intervening nutrition The division is responsible for designing menus that contain information on how to purchase special dietary formulas, calculate and cook, and possibly prepare food for future problem solving. Results were presented as mean ± SD. Statistical analysis was performed using SPSS software version 21.0. Difference in patients' dietary intake and biochemical values were compared for the significant differences at 1st, 2th month using one-way analysis of variance (ANOVA). Comparison of male and female baseline characteristics were using by unpaired t-test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Ketogenic Dieting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients received ketogenic diet then Balanced diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients received Balanced diet then ketogenic diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic diet
Intervention Description
The course of the trial to medium-chain triglyceride lipid intervening 50-70% of dietary intake
Intervention Type
Dietary Supplement
Intervention Name(s)
Balanced diet
Intervention Description
Balanced diet
Primary Outcome Measure Information:
Title
urine albumin creatinine ratio
Description
By using urine albumin creatinine ratio to determine whether the ketogenic diet could result in less proteinuria
Time Frame
8 times: Day1, 1st week, 1st month, 2nd month during ketogenic diet then Day1, 1st week, 1st month, 2nd month during balanced diet
Title
Change in Inflammatory cytokine
Description
By testing blood inflammatory cytokine: TNF-α, IL-6, IL-10 and IL-17 to evaluate whether the ketogenic diet could decrease systemic inflammation
Time Frame
8 times: Day1, 1st week, 1st month, 2nd month during ketogenic diet then Day1, 1st week, 1st month, 2nd month during balanced diet
Secondary Outcome Measure Information:
Title
Change of subclass of T cells
Description
By using flow cytometry to detect the change of subclasses of blood T cells after ketogenic diet
Time Frame
2 times: 2nd month during ketogenic diet then 2nd month during balanced diet
Title
Change of Gut microbiota analysis
Description
By using new generation sequencing to detect the change of gut microbiota after ketogenicdiet
Time Frame
2 times: 2nd month during ketogenic diet then 2nd month during balanced diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Can't cooperate the diet intervention Rapid progression of renal function, or already need renal replacement therapy (Dialysis or kidney transplantation)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chieh-Li Yen, MD
Phone
+886975367240
Email
b9102087@gmail.com
Facility Information:
Facility Name
Chang Gung memorial hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chieh-Li Yen, MD
Phone
0975367240
Email
b9102087@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity

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