Effects of Fasting Mimetic Diet on Nephropatic Patients

Study Overview
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Brief Summary
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Fasting mimetic diet (FMD) showed positive effects on cardiovascular risks. Purpose of the trial is to evaluate FMD effects on patients affected by chronic kidney disease (CKD), through the stimulation of kidney stem cells and improving cardiovascular and metabolic status. From April 2018, the investigators enrolled 13 patients (7 male) with an history of primary glomerulonephritis (GMN) and an eGFR between 60 ml/min and 30 ml/min. Exclusion criteria are: age <18 y.o., age> 65 y.o., secondary GMN, severe heart failure (NYHA IV),ongoing infectious diseases, ongoing neoplasia, hepatic diseases, COPD, inflammatory bowel disease, history of stroke, history of acute coronary disease less than 3 months, pregnancy, refuse informed consent.

Official Title
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Effects of Fasting Mimetic Diet on Nephropatic Patients

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Dietary Supplement: Fasting mimetic diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of primary glomerulonephritis eGFR between 60 ml/min and 30 ml/min age between 18-65 years old Exclusion Criteria: secondary GMN severe heart failure (NYHA IV) ongoing infectious diseases ongoing neoplasia, hepatic diseases COPD, inflammatory bowel disease history of stroke history of acute coronary disease less than 3 months pregnancy refuse informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Free diet<br>Free diet | |
| Experimental: FMD<br>Fasting mimetic diet for 5 days, next cycle after 25 days of free diet | Dietary Supplement: Fasting mimetic diet<br>* Fasting mimetic diet for 5 days, another cycle after 25 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%) |  | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine (mg/dl) |  | Baseline to 6 months | 
| Blood urea (mg/dl) |  | Baseline to 6 months | 
| Reactive C-protein (mg/L) |  | Baseline to 6 months | 
| Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl) |  | Baseline to 6 months | 
| blood glucose (mg/dl) |  | Baseline to 6 months | 
| iPTH (ng/ml) |  | Baseline to 6 months | 
| Total protein (g/L) |  | Baseline to 6 months | 
| Blood insulin (mcUI/ml) |  | Baseline to 6 months | 
| Blood uric acid (mg/dl) |  | Baseline to 6 months | 
| Flow-mediated dilation (%) |  | Baseline to 6 months | 
| Intima-media thickness (mm) |  | Baseline to 6 months | 
| eGFR using CKD-EPI and MDRD (ml/min/1,73 m2) |  | Baseline to 6 months | 
| Renal resistive index (dimensionless) |  | Baseline to 6 months | 
| Epicardial Adipose Tissue (cm) |  | Baseline to 6 months | 
| Beck depression inventory II (BDI-II) (0 to 63 points) |  | Baseline to 6 months | 
| BMI (kg/m^2) |  | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Fasting mimetic diet, Kidney stem cells