Effects of Fasting Mimetic Diet on Nephropatic Patients

July 23, 2020 updated by: Silvia Lai, University of Roma La Sapienza

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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+) (%)
Time Frame: Baseline to 6 months
Baseline to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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