Chronic Kidney DiseasePISNCT01865526
Efficacy of the 6-point Diet
A study testing Six point diet and Low protein diet in people with Chronic Kidney Disease, run by Federico II University at 1 site in Italy.
Trial summary
The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic kidney disease (CKD) and of its metabolic consequences. Dietary adjustments in CKD are complex and the patients' compliance is very low. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Six point diet and Low protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to Dec 2012
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >18 years
- a basal value of estimated GFR (eGFR) < 45 ml/min/1,73 m2, that had to remain stable during 3 consecutive controls (eGFR variability <15% along 1 month)
Who cannot join
- unstable renal function,
- inability to perform correct 24-hours urine collections,
- presence of malignancies,
- treatment with immunosuppressive drugs,
- pregnancy,
- congestive heart failure (NYHA class III-IV),
- proteinuria >3,5 g/24 hours
Trial locations and contacts
1 site in 1 country.
Italy1 site
federico II university, department of nephrology
Naples, Naples, 80129
About this study
Official title: Effects of the 6-point Diet on the Metabolic Control, the Compliance and the Nutritional Status of CKD Patients Stage 3b-5
The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic kidney disease (CKD) and of its metabolic consequences. Dietary adjustments in CKD are complex and the patients' compliance is very low. A dietary interview method is a validated instrument to evaluate the patients' compliance; however, it the presence of a dedicated dietitians. For these reasons, and because of the absence of dedicated dietitians in many nephrology centres, it is usual practice to give standard low protein diets to CKD patients not on dialysis.
Aim of this study was to verify if few simple tips were able to reduce protein, phosphate and sodium intake in patients with CKD, as compared to the practice of giving a low protein diet elaborated by a renal dietitian.
Read the detailed description
The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic kidney disease (CKD) and of its metabolic consequences. In fact, a reduced protein intake decreases load on remaining nephrons, reduces signs and symptoms of uraemia, lessens the accumulation of waste metabolic products and oxidant stress, improves insulin-resistance and lipid profile, ameliorates proteinuria, additives effects of angiotensin-converting-enzyme inhibitors, and decreases likelihood of patients death or delays initiation of dialysis by 40%.
Dietary adjustments in subjects with chronic renal failure are complex because multiple nutrient modifications are required and changes in lifestyle must be maintained for years. Furthermore, low-protein diet is considered tedious, unpalatable and difficult to achieve. This has an obvious negative influence on the quality of life of patients and makes their adherence to the new therapeutic prescriptions more difficult. In fact, the difficulty to reach patients' compliance is well known. There is ample evidence that poor adherence is considered a critical barrier to treatment success and remains one of the leading challenges to healthcare professionals. Few data are available in clinical practice concerning the patients' compliance to low protein diet. A dietary interview method is a validated instrument to evaluate the practice and routines related to the assessment of nutrient intake in nondialyzed CKD patients and to obtain the patients' compliance. However, the interview requires the presence of a dedicated dietitian and a lot of his time.
For these reasons, and because of the absence of dedicated dietitians in many nephrology centres, it is usual practice to give standard low protein diets to CKD patients not on dialysis.
Aim of this study was to verify if few simple tips were able to reduce protein, phosphate and sodium intake in patients with CKD, as compared to the practice of giving a low protein diet elaborated by a renal dietitian.
- Conditions
- Chronic Kidney Disease
- Being tested
- Six point diet, Low protein diet
- Keywords
- Chronic kidney disease, Low protein diet, CKD stage 3b-5
- 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.
Six point dietDietary supplement
The 6-point diet is a list of six items indicating how to modify their dietary habits:
- Do not add salt at table and for cooking;
- Food to avoid: any kind of salami, sausages, cheese and dairy products or canned food;
- Replace noodle or bread with special no-protein food;
- The second course (meat, fish and eggs) are allowed once a day in the usual quantity;
- 4-5 servings/day of fruits or vegetables are suggested;
- Once or twice a week the main course may be of "normal" noodle with legumes instead of the second course, with fruit and vegetables.
Low protein dietDietary supplement
Classical low-protein diet prescribed according to the patients' desired body weight (DBW), obtained by multiplying the squared value of the height times a reference BMI value of 23. These diets contained at least 30 kcal/kg/day (25 in overweight patients), with a dietary sodium intake restricted to 2.5 g/day.
| Study group | Role | What they receive |
|---|---|---|
| Low protein diet | Active comparator | The patients of this group received a classical low protein diet (LPD),according to their desired body weight (DBW), obtained by multiplying the squared value of the height times a reference body mass index (BMI) value of 23. LPD were individually prepared and explained to the patients by a dedicated dietician and contained at least 30 kcal/kg/day (25 in overweight patients), with a dietary sodium intake restricted to 2.5 g/day. Receives: Dietary Supplement: Low protein diet |
| Six point diet | Experimental | These patients were assigned to receive the 6-points-diet, and were given by the Nephrologist the list of six items indicating how to modify their dietary habits; all the items were thoroughly explained and discussed with the patients Receives: Dietary Supplement: Six point diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on renal disease progression
Evaluation of modification of GFR and proteinuria
Measured: 6 months
Effect on metabolic control
Evaluation of the modifications of serum urea nitrogen, sodium, potassium, phosphate, bicarbonate, parathormone , urinary urea nitrogen, phosphate, potassium, sodium, protein and phosphate intake
Measured: 6 months
Effect on nutritional status
Evaluation of modifications of total protein, albumin, C-reactive protein, body weight, BMI
Measured: 6 months
Effect on patients'compliance to the dietetic therapy
The compliance was defined by a constant protein intake between 0.7 and 0.9 g/kg B.W. throughout the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Riccio, Federico II University
- Investigators
- eleonora riccio, md, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865526
- Sponsor's protocol ID
- PIS
- Other IDs
- Carlo Romano
- Acronym
- PIS
- Status last verified
- Dec 2012
- First submitted
- 24 May 2013
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pisani A, Riccio E, Bellizzi V, Caputo DL, Mozzillo G, Amato M, Andreucci M, Cianciaruso B, Sabbatini M. 6-tips diet: a simplified dietary approach in patients with chronic renal disease. A clinical randomized trial. Clin Exp Nephrol. 2016 Jun;20(3):433-42. doi: 10.1007/s10157-015-1172-5. Epub 2015 Oct 9.
PubMed 26453483
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the 6-point Diet on the Metabolic Control, the Compliance and the Nutritional Status of CKD Patients Stage 3b-5
- ClinicalTrials.gov ID
- NCT01865526
- Acronym / sponsor ID
- PIS / PIS
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Low protein diet, CKD stage 3b-5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 May 2013 (estimated)
- 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.
The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic kidney disease (CKD) and of its metabolic consequences. Dietary adjustments in CKD are complex and the patients' compliance is very low. A dietary interview method is a validated instrument to evaluate the patients' compliance; however, it the presence of a dedicated dietitians. For these reasons, and because of the absence of dedicated dietitians in many nephrology centres, it is usual practice to give standard low protein diets to CKD patients not on dialysis.
Aim of this study was to verify if few simple tips were able to reduce protein, phosphate and sodium intake in patients with CKD, as compared to the practice of giving a low protein diet elaborated by a renal dietitian.
Detailed description
The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic kidney disease (CKD) and of its metabolic consequences. In fact, a reduced protein intake decreases load on remaining nephrons, reduces signs and symptoms of uraemia, lessens the accumulation of waste metabolic products and oxidant stress, improves insulin-resistance and lipid profile, ameliorates proteinuria, additives effects of angiotensin-converting-enzyme inhibitors, and decreases likelihood of patients death or delays initiation of dialysis by 40%.
Dietary adjustments in subjects with chronic renal failure are complex because multiple nutrient modifications are required and changes in lifestyle must be maintained for years. Furthermore, low-protein diet is considered tedious, unpalatable and difficult to achieve. This has an obvious negative influence on the quality of life of patients and makes their adherence to the new therapeutic prescriptions more difficult. In fact, the difficulty to reach patients' compliance is well known. There is ample evidence that poor adherence is considered a critical barrier to treatment success and remains one of the leading challenges to healthcare professionals. Few data are available in clinical practice concerning the patients' compliance to low protein diet. A dietary interview method is a validated instrument to evaluate the practice and routines related to the assessment of nutrient intake in nondialyzed CKD patients and to obtain the patients' compliance. However, the interview requires the presence of a dedicated dietitian and a lot of his time.
For these reasons, and because of the absence of dedicated dietitians in many nephrology centres, it is usual practice to give standard low protein diets to CKD patients not on dialysis.
Aim of this study was to verify if few simple tips were able to reduce protein, phosphate and sodium intake in patients with CKD, as compared to the practice of giving a low protein diet elaborated by a renal dietitian.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low protein diet | Active comparator | Dietary Supplement: Low protein dietThe patients of this group received a classical low protein diet (LPD),according to their desired body weight (DBW), obtained by multiplying the squared value of the height times a reference body mass index (BMI) value of 23. LPD were individually prepared and explained to the patients by a dedicated dietician and contained at least 30 kcal/kg/day (25 in overweight patients), with a dietary sodium intake restricted to 2.5 g/day. |
| Six point diet | Experimental | Dietary Supplement: Six point dietThese patients were assigned to receive the 6-points-diet, and were given by the Nephrologist the list of six items indicating how to modify their dietary habits; all the items were thoroughly explained and discussed with the patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age >18 years
- a basal value of estimated GFR (eGFR) < 45 ml/min/1,73 m2, that had to remain stable during 3 consecutive controls (eGFR variability <15% along 1 month)
Key exclusion criteria (7 listed)
- unstable renal function,
- inability to perform correct 24-hours urine collections,
- presence of malignancies,
- treatment with immunosuppressive drugs,
- pregnancy,
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 |
|---|---|---|
| Six point dietThe 6-point diet is a list of six items indicating how to modify their dietary habits: 1. Do not add salt at table and for cooking; 2. Food to avoid: any kind of salami, sausages, cheese and dairy products or canned food; 3. Replace noodle or bread with special no-protein food; 4. The second course (meat, fish and eggs) are allowed once a day in the usual quantity; 5. 4-5 servings/day of fruits or vegetables are suggested; 6. Once or twice a week the main course may be of "normal" noodle with legumes instead of the second course, with fruit and vegetables. | Dietary supplement | Six point diet |
| Low protein dietClassical low-protein diet prescribed according to the patients' desired body weight (DBW), obtained by multiplying the squared value of the height times a reference BMI value of 23. These diets contained at least 30 kcal/kg/day (25 in overweight patients), with a dietary sodium intake restricted to 2.5 g/day. | Dietary supplement | Low protein diet |
Primary outcome
Effect on renal disease progression
Time frame: 6 months
Evaluation of modification of GFR and proteinuria
Effect on metabolic control
Time frame: 6 months
Evaluation of the modifications of serum urea nitrogen, sodium, potassium, phosphate, bicarbonate, parathormone , urinary urea nitrogen, phosphate, potassium, sodium, protein and phosphate intake
Effect on nutritional status
Time frame: 6 months
Evaluation of modifications of total protein, albumin, C-reactive protein, body weight, BMI
Effect on patients'compliance to the dietetic therapy
Time frame: 6 months
The compliance was defined by a constant protein intake between 0.7 and 0.9 g/kg B.W. throughout the study
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 31 May 2013.
- Derived from this study: PubMed 26453483Pisani A, Riccio E, Bellizzi V, Caputo DL, Mozzillo G, Amato M, Andreucci M, Cianciaruso B, Sabbatini M. 6-tips diet: a simplified dietary approach in patients with chronic renal disease. A clinical randomized trial. Clin Exp Nephrol. 2016 Jun;20(3):433-42. doi: 10.1007/s10157-015-1172-5. Epub 2015 Oct 9.
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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.
eleonora riccio, md principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six point diet and Low protein diet in people with Chronic Kidney Disease, run by Federico II University 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 2 inclusion and 7 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 31 May 2013. 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?
Effect on renal disease progression (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01865526, which also lists 1 linked publication.
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 31 May 2013.