Effects of Fasting Mimetic Diet on Nephropatic Patients

Renal Insufficiency, Chronic Clinical Trial

Official title:

Effects of Fasting Mimetic Diet on Nephropatic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490252
• Other study ID #: FMD1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Fasting mimetic diet
Fasting mimetic diet for 5 days, another cycle after 25 days

Locations

Country	Name	City	State
Italy	Hospital "Umberto I", University of Rome "Sapienza"	Roma	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)		Baseline to 6 months
Secondary	Creatinine (mg/dl)		Baseline to 6 months
Secondary	Blood urea (mg/dl)		Baseline to 6 months
Secondary	Reactive C-protein (mg/L)		Baseline to 6 months
Secondary	Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl)		Baseline to 6 months
Secondary	blood glucose (mg/dl)		Baseline to 6 months
Secondary	iPTH (ng/ml)		Baseline to 6 months
Secondary	Total protein (g/L)		Baseline to 6 months
Secondary	Blood insulin (mcUI/ml)		Baseline to 6 months
Secondary	Blood uric acid (mg/dl)		Baseline to 6 months
Secondary	Flow-mediated dilation (%)		Baseline to 6 months
Secondary	Intima-media thickness (mm)		Baseline to 6 months
Secondary	eGFR using CKD-EPI and MDRD (ml/min/1,73 m2)		Baseline to 6 months
Secondary	Renal resistive index (dimensionless)		Baseline to 6 months
Secondary	Epicardial Adipose Tissue (cm)		Baseline to 6 months
Secondary	Beck depression inventory II (BDI-II) (0 to 63 points)		Baseline to 6 months
Secondary	BMI (kg/m^2)		Baseline to 6 months