Renal Insufficiency, ChronicNCT04490252
Effects of Fasting Mimetic Diet on Nephropatic Patients
A study testing Fasting mimetic diet in people with Renal Insufficiency, Chronic, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Fasting mimetic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of primary glomerulonephritis
- eGFR between 60 ml/min and 30 ml/min
- age between 18-65 years old
Who cannot join
- secondary GMN
- severe heart failure (NYHA IV)
- ongoing infectious diseases
- ongoing neoplasia,
- hepatic diseases
- COPD,
Show all 11Show fewer
- inflammatory bowel disease
- history of stroke
- history of acute coronary disease less than 3 months
- pregnancy
- refuse informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Hospital "Umberto I", University of Rome "Sapienza"
Rome, Lazio, 00185
About this study
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
- Being tested
- Fasting mimetic diet
- Keywords
- Chronic kidney disease, Fasting mimetic diet, Kidney stem cells
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting mimetic dietDietary supplement
Fasting mimetic diet for 5 days, another cycle after 25 days
| Study group | Role | What they receive |
|---|---|---|
| Free diet | No intervention | Free diet |
| FMD | Experimental | Fasting mimetic diet for 5 days, next cycle after 25 days of free diet Receives: Dietary Supplement: Fasting mimetic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)
Measured: Baseline to 6 months
Secondary outcomes (16)
Creatinine (mg/dl)
Measured: Baseline to 6 months
Blood urea (mg/dl)
Measured: Baseline to 6 months
Reactive C-protein (mg/L)
Measured: Baseline to 6 months
Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl)
Measured: Baseline to 6 months
blood glucose (mg/dl)
Measured: Baseline to 6 months
iPTH (ng/ml)
Measured: Baseline to 6 months
Total protein (g/L)
Measured: Baseline to 6 months
Blood insulin (mcUI/ml)
Measured: Baseline to 6 months
Blood uric acid (mg/dl)
Measured: Baseline to 6 months
Flow-mediated dilation (%)
Measured: Baseline to 6 months
Intima-media thickness (mm)
Measured: Baseline to 6 months
eGFR using CKD-EPI and MDRD (ml/min/1,73 m2)
Measured: Baseline to 6 months
Renal resistive index (dimensionless)
Measured: Baseline to 6 months
Epicardial Adipose Tissue (cm)
Measured: Baseline to 6 months
Beck depression inventory II (BDI-II) (0 to 63 points)
Measured: Baseline to 6 months
BMI (kg/m^2)
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Apr 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lai, University of Roma La Sapienza
- Investigators
- Silvia Lai, Prof., Principal investigator, University of Rome "Sapienza"- Department of Translational and Precision Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490252
- Sponsor's protocol ID
- FMD1
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fasting Mimetic Diet on Nephropatic Patients
- ClinicalTrials.gov ID
- NCT04490252
- Acronym / sponsor ID
- FMD1
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Chronic kidney disease, Fasting mimetic diet, Kidney stem cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free diet | No intervention | –Free diet |
| FMD | Experimental | Dietary Supplement: Fasting mimetic dietFasting mimetic diet for 5 days, next cycle after 25 days of free diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of primary glomerulonephritis
- eGFR between 60 ml/min and 30 ml/min
- age between 18-65 years old
Key exclusion criteria (11 listed)
- secondary GMN
- severe heart failure (NYHA IV)
- ongoing infectious diseases
- ongoing neoplasia,
- hepatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting mimetic dietFasting mimetic diet for 5 days, another cycle after 25 days | Dietary supplement | FMD |
Primary outcome
Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)
Time frame: Baseline to 6 months
16 secondary outcomes
Creatinine (mg/dl)
Time frame: Baseline to 6 months
Blood urea (mg/dl)
Time frame: Baseline to 6 months
Reactive C-protein (mg/L)
Time frame: Baseline to 6 months
Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl)
Time frame: Baseline to 6 months
blood glucose (mg/dl)
Time frame: Baseline to 6 months
iPTH (ng/ml)
Time frame: Baseline to 6 months
Total protein (g/L)
Time frame: Baseline to 6 months
Blood insulin (mcUI/ml)
Time frame: Baseline to 6 months
Blood uric acid (mg/dl)
Time frame: Baseline to 6 months
Flow-mediated dilation (%)
Time frame: Baseline to 6 months
Intima-media thickness (mm)
Time frame: Baseline to 6 months
eGFR using CKD-EPI and MDRD (ml/min/1,73 m2)
Time frame: Baseline to 6 months
Renal resistive index (dimensionless)
Time frame: Baseline to 6 months
Epicardial Adipose Tissue (cm)
Time frame: Baseline to 6 months
Beck depression inventory II (BDI-II) (0 to 63 points)
Time frame: Baseline to 6 months
BMI (kg/m^2)
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Lai, Prof. principal investigator
University of Rome "Sapienza"- Department of Translational and Precision Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting mimetic diet in people with Renal Insufficiency, Chronic, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.