NCT04490252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

July 1, 2020

Last Update Submit

July 23, 2020

Conditions

Renal Insufficiency, Chronic

Keywords

Chronic kidney diseaseFasting mimetic dietKidney stem cells

Outcome Measures

Primary Outcomes (1)

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

    Baseline to 6 months

Secondary Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (2)

Free diet

NO INTERVENTION

Free diet

FMD

EXPERIMENTAL

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

Dietary Supplement: Fasting mimetic diet

Interventions

Fasting mimetic dietDIETARY_SUPPLEMENT

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

FMD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of primary glomerulonephritis
  • eGFR between 60 ml/min and 30 ml/min
  • age between 18-65 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rome, Lazio, 00185, Italy

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Silvia Lai, Prof.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 29, 2020

Study Start

April 1, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)