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Effects of Fasting Mimetic Diet on Nephropatic Patients

Primary Purpose

Renal Insufficiency, Chronic

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fasting mimetic diet
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Chronic kidney disease, Fasting mimetic diet, Kidney stem cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital "Umberto I", University of Rome "Sapienza"

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Free diet

FMD

Arm Description

Free diet

Fasting mimetic diet for 5 days, next cycle after 25 days of free diet

Outcomes

Primary Outcome Measures

Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2020
Last Updated
July 23, 2020
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT04490252
Brief Title
Effects of Fasting Mimetic Diet on Nephropatic Patients
Official Title
Effects of Fasting Mimetic Diet on Nephropatic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
Chronic kidney disease, Fasting mimetic diet, Kidney stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Free diet
Arm Type
No Intervention
Arm Description
Free diet
Arm Title
FMD
Arm Type
Experimental
Arm Description
Fasting mimetic diet for 5 days, next cycle after 25 days of free diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Fasting mimetic diet
Intervention Description
Fasting mimetic diet for 5 days, another cycle after 25 days
Primary Outcome Measure Information:
Title
Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Creatinine (mg/dl)
Time Frame
Baseline to 6 months
Title
Blood urea (mg/dl)
Time Frame
Baseline to 6 months
Title
Reactive C-protein (mg/L)
Time Frame
Baseline to 6 months
Title
Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl)
Time Frame
Baseline to 6 months
Title
blood glucose (mg/dl)
Time Frame
Baseline to 6 months
Title
iPTH (ng/ml)
Time Frame
Baseline to 6 months
Title
Total protein (g/L)
Time Frame
Baseline to 6 months
Title
Blood insulin (mcUI/ml)
Time Frame
Baseline to 6 months
Title
Blood uric acid (mg/dl)
Time Frame
Baseline to 6 months
Title
Flow-mediated dilation (%)
Time Frame
Baseline to 6 months
Title
Intima-media thickness (mm)
Time Frame
Baseline to 6 months
Title
eGFR using CKD-EPI and MDRD (ml/min/1,73 m2)
Time Frame
Baseline to 6 months
Title
Renal resistive index (dimensionless)
Time Frame
Baseline to 6 months
Title
Epicardial Adipose Tissue (cm)
Time Frame
Baseline to 6 months
Title
Beck depression inventory II (BDI-II) (0 to 63 points)
Time Frame
Baseline to 6 months
Title
BMI (kg/m^2)
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Lai, Prof.
Organizational Affiliation
University of Rome "Sapienza"- Department of Translational and Precision Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital "Umberto I", University of Rome "Sapienza"
City
Roma
State/Province
Lazio
ZIP/Postal Code
00185
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Fasting Mimetic Diet on Nephropatic Patients

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