Effects of Fasting Mimetic Diet on Nephropatic Patients

NCT ID: NCT04490252

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-07-01

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.

Conditions

Renal Insufficiency, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Free diet

Free diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

FMD

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

Group Type: EXPERIMENTAL

Fasting mimetic diet

Intervention Type: DIETARY_SUPPLEMENT

Fasting mimetic diet for 5 days, another cycle after 25 days

Interventions

Fasting mimetic diet

Fasting mimetic diet for 5 days, another cycle after 25 days

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Silvia Lai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Lai, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Rome "Sapienza"- Department of Translational and Precision Medicine

Locations

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

Rome, Lazio, Italy

Countries

Italy

Other Identifiers

FMD1

Identifier Type: -

Identifier Source: org_study_id