Effects of Fasting Mimetic Diet on Nephropatic Patients

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Dietary supplement: Fasting mimetic diet

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00185
      • Hospital "Umberto I", University of Rome "Sapienza"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Free diet
Experimental: FMD; Fasting mimetic diet for 5 days, next cycle after 25 days of free diet	Dietary supplement: Fasting mimetic diet; Fasting mimetic diet for 5 days, another cycle after 25 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Silvia Lai, Prof., University of Rome "Sapienza"- Department of Translational and Precision Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Fasting mimetic diet; Kidney stem cells
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: FMD1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No