Systemic Lupus ErythematosusNCT05689580
The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity
A study testing Ketogenic diet and Balanced diet in people with Systemic Lupus Erythematosus and Ketogenic Dieting, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Ketogenic Dieting
- What is being tested?
- Ketogenic diet and Balanced diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Can't cooperate the diet intervention
- Rapid progression of renal function, or already need renal replacement therapy (Dialysis or kidney transplantation)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung memorial hospital
Taoyuan, 333
Chieh-Li Yen, MD, 0975367240, b9102087@gmail.com
About this study
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus, Ketogenic Dieting
- Being tested
- Ketogenic diet, Balanced diet
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietDietary supplement
The course of the trial to medium-chain triglyceride lipid intervening 50-70% of dietary intake
Balanced dietDietary supplement
Balanced diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Ketogenic diet; Dietary Supplement: Balanced diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine albumin creatinine ratio
By using urine albumin creatinine ratio to determine whether the ketogenic diet could result in less proteinuria
Measured: 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
Measured: 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
By using flow cytometry to detect the change of subclasses of blood T cells after ketogenic diet
Measured: 2 times: 2nd month during ketogenic diet then 2nd month during balanced diet
Change of Gut microbiota analysis
By using new generation sequencing to detect the change of gut microbiota after ketogenicdiet
Measured: 2 times: 2nd month during ketogenic diet then 2nd month during balanced diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Sep 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689580
- Sponsor's protocol ID
- 202001487A3C102
- Status last verified
- Sep 2022
- First submitted
- 10 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity
- ClinicalTrials.gov ID
- NCT05689580
- Acronym / sponsor ID
- 202001487A3C102
- Conditions
- Systemic Lupus Erythematosus, Ketogenic Dieting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Jan 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients received ketogenic diet then Balanced diet | Experimental | Dietary Supplement: Ketogenic diet, Dietary Supplement: Balanced dietsubjects 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. |
| Patients received Balanced diet then ketogenic diet | Experimental | Dietary Supplement: Ketogenic diet, Dietary Supplement: Balanced dietsubjects 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Can't cooperate the diet intervention
- Rapid progression of renal function, or already need renal replacement therapy (Dialysis or kidney transplantation)
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 |
|---|---|---|
| Ketogenic dietThe course of the trial to medium-chain triglyceride lipid intervening 50-70% of dietary intake | Dietary supplement | Patients received Balanced diet then ketogenic diet, Patients received ketogenic diet then Balanced diet |
| Balanced dietBalanced diet | Dietary supplement | Patients received Balanced diet then ketogenic diet, Patients received ketogenic diet then Balanced diet |
Primary outcome
urine albumin creatinine ratio
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
By using urine albumin creatinine ratio to determine whether the ketogenic diet could result in less proteinuria
Change in Inflammatory cytokine
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
By testing blood inflammatory cytokine: TNF-α, IL-6, IL-10 and IL-17 to evaluate whether the ketogenic diet could decrease systemic inflammation
2 secondary outcomes
Change of subclass of T cells
Time frame: 2 times: 2nd month during ketogenic diet then 2nd month during balanced diet
Change of Gut microbiota analysis
Time frame: 2 times: 2nd month during ketogenic diet then 2nd month during balanced diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet and Balanced diet in people with Systemic Lupus Erythematosus and Ketogenic Dieting, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 2023. 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 Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chieh-Li Yen, MD (+886975367240, b9102087@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine albumin creatinine ratio (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2023.