Effects of Fasting Mimetic Diet on Nephropatic Patients
- Conditions
- Renal Insufficiency, Chronic
- Interventions
- Dietary Supplement: Fasting mimetic diet
- Registration Number
- NCT04490252
- Lead Sponsor
- University of Roma La Sapienza
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- History of primary glomerulonephritis
- eGFR between 60 ml/min and 30 ml/min
- age between 18-65 years old
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description FMD Fasting mimetic diet Fasting mimetic diet for 5 days, next cycle after 25 days of free diet
- Primary Outcome Measures
Name Time Method Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%) Baseline to 6 months
- Secondary Outcome Measures
Name Time Method blood glucose (mg/dl) Baseline to 6 months Flow-mediated dilation (%) Baseline to 6 months eGFR using CKD-EPI and MDRD (ml/min/1,73 m2) Baseline to 6 months Epicardial Adipose Tissue (cm) Baseline to 6 months BMI (kg/m^2) Baseline to 6 months 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 iPTH (ng/ml) Baseline to 6 months Total protein (g/L) Baseline to 6 months Blood insulin (mcUI/ml) Baseline to 6 months Intima-media thickness (mm) Baseline to 6 months Blood uric acid (mg/dl) Baseline to 6 months Renal resistive index (dimensionless) Baseline to 6 months Beck depression inventory II (BDI-II) (0 to 63 points) Baseline to 6 months
Trial Locations
- Locations (1)
Hospital "Umberto I", University of Rome "Sapienza"
🇮🇹Roma, Lazio, Italy