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Renal Effects of Meditarranean Diet and Low-protein Diet With Ketoacids on Physiological Intestinal Mibrobiota in CKD (MEDIKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02302287
Recruitment Status : Unknown
Verified January 2016 by Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2.
Recruitment status was:  Active, not recruiting
First Posted : November 27, 2014
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2

Brief Summary:

Food intake has a deep influence on gut microbiota composition and function, both in health and in disease status. In chronic kidney disease (CKD), a microbiota dysbiosis status is observed. Moreover, many toxic uremic molecules are microbial-derived and their accumulation promotes, in turn, disease progression.

Investigators' hypothesis foresees a beneficial effect of nutritional treatments, able to restore gut microbiota balance, to lower microbial-derived uremic toxins and to improve clinical conditions in CKD patients.

Mediterranean Diet (MD) is supposed to have beneficial effect on microbiota composition, while low-protein diet supplemented with ketoacids (KD) is used in CKD patients for the improvement of clinical conditions, but its effects on gut microbiota are currently unknown. Investigators' project aim is to verify the effects of MD and KD on: microbiota and metabolome composition, microbial-derived uremic toxins level and clinical conditions in a cohort of CKD patients.


Condition or disease Intervention/treatment Phase
Chronic Renal Insufficiency Dietary Supplement: Ketoacids diet Other: Mediterranean diet Other: Free diet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gut-kidney Axis: Renal Effects of Meditarranean Diet and Low-protein Diet With Ketoacids to Restore Physiological Intestinal Mibrobiota in Chronic Kidney Disease
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Group A
  1. Free diet for 3 months: protein 1 g/body weight/day (animal protein 50-70 g/day, plant protein 15-20 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 6 g/day, potassium 2-4 g/day;
  2. Ketoacids diet for 6 months: protein 0,3-0,5 g/bw/day (animal protein 0 g/day, plant protein 30-40 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 0,6-0,8 g/day; sodium 6 g/day, potassium 2-4 g/day; mixture of essential aminoacids and ketoacids 0,05 g/kg ideal bw/day
  3. Mediterranean diet for 6 months: protein 0,7-0,8 g/bw/day (animal protein 30-40 g/day, plant protein 40-50 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 2,5-3 g/day, potassium 2-4 g/day
  4. Mediterranean diet and ketoacids for 6 months
Dietary Supplement: Ketoacids diet
Ketoacids diet for 6 months: protein 0,3-0,5 g/bw/day (animal protein 0 g/day, plant protein 30-40 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 0,6-0,8 g/day; sodium 6 g/day, potassium 2-4 g/day; mixture of essential aminoacids and ketoacids 0,05 g/kg ideal bw/day
Other Name: KD

Other: Mediterranean diet
Mediterranean diet for 6 months: protein 0,7-0,8 g/bw/day (animal protein 30-40 g/day, plant protein 40-50 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 2,5-3 g/day, potassium 2-4 g/day
Other Name: MD

Other: Free diet
Free diet for 3 months: protein 1 g/body weight/day (animal protein 50-70 g/day, plant protein 15-20 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 6 g/day, potassium 2-4 g/day;
Other Name: FD

Experimental: Group B
  1. Free diet for 3 months: protein 1 g/body weight/day (animal protein 50-70 g/day, plant protein 15-20 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 6 g/day, potassium 2-4 g/day;
  2. Mediterranean diet for 6 months: protein 0,7-0,8 g/bw/day (animal protein 30-40 g/day, plant protein 40-50 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 2,5-3 g/day, potassium 2-4 g/day;
  3. Ketoacids diet for 6 months: protein 0,3-0,5 g/bw/day (animal protein 0 g/day, plant protein 30-40 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 0,6-0,8 g/day; sodium 6 g/day, potassium 2-4 g/day; mixture of essential aminoacids and ketoacids 0,05 g/kg ideal bw/day
  4. Mediterranean diet and ketoacids for 6 months
Dietary Supplement: Ketoacids diet
Ketoacids diet for 6 months: protein 0,3-0,5 g/bw/day (animal protein 0 g/day, plant protein 30-40 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 0,6-0,8 g/day; sodium 6 g/day, potassium 2-4 g/day; mixture of essential aminoacids and ketoacids 0,05 g/kg ideal bw/day
Other Name: KD

Other: Mediterranean diet
Mediterranean diet for 6 months: protein 0,7-0,8 g/bw/day (animal protein 30-40 g/day, plant protein 40-50 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 2,5-3 g/day, potassium 2-4 g/day
Other Name: MD

Other: Free diet
Free diet for 3 months: protein 1 g/body weight/day (animal protein 50-70 g/day, plant protein 15-20 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 6 g/day, potassium 2-4 g/day;
Other Name: FD

Group control
Free diet: protein 1 g/body weight/day (animal protein 50-70 g/day, plant protein 15-20 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 6 g/day, potassium 2-4 g/day
Other: Free diet
Free diet for 3 months: protein 1 g/body weight/day (animal protein 50-70 g/day, plant protein 15-20 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 6 g/day, potassium 2-4 g/day;
Other Name: FD




Primary Outcome Measures :
  1. Change from baseline in fecal microbiota by MD and KD at 18 months [ Time Frame: 0-18 months from the beginning of the study ]
    Active fecal microbiota will be analyzed a culture-independent methods. Bacterial tag encoded FLX-titanium amplican pyrosequencing (bTEFAP) analyses will be carried out for bacterial RNA directly extracted from feces at months 0, 3, 9, 12 and 18.


Secondary Outcome Measures :
  1. Change from baseline in microbial-derived uremic toxins level at 18 months [ Time Frame: 0-18 months from the beginning of the study ]
    Untarget metabolomic analysis will be carried out on fecal and urine samples collected at months 0,3,9,12 and 18 after the beginning of the study for volatile organic compounds (VOC) (GC-MS/MS) and non-VOC profiling (LC-MS/MS). Sera collected at the same time points will be also analyzed by untarget metabolomic for non-VOC profiling and by target matabolomic to quantify uremic toxins, as indoxyl sulfate and p-cresyl sulfate, and potential metabolite biomarkers found by the untarget experiment

  2. Change from baseline in renal function at 18 months [ Time Frame: 0-18 months from the beginning of the study ]
    each patient will provide at months 0,3,9,12 and 18 blood and urine samples for routine analyses to measure urea, creatinine, estimated glomerular filtration rate, BUN, blood pressure, proteinuria

  3. Change from baseline in nutritional status at 18 months [ Time Frame: 0-18 months from the beginning of the study ]
    each patient will provide at months 0,3,9,12 and 18 blood and urine samples for routine analyses to measure acid-basic balance, serum and urine electrolytes, PTH, serum proteins, haemoglobin,

  4. Change from baseline in inflammatory status at 18 months [ Time Frame: 0-18 months from the beginning of the study ]
    each patient will provide at months 0,3,9,12 and 18 blood and urine samples for routine analyses to measure EGF/MCP-1 ratio, CRP, TNF-a, IL-6

  5. Change from baseline in microbial-derived uremic toxins level at 18 months [ Time Frame: 0-18 months from the beginning of the study ]
    Sera will be collected at months 0,3,9,12 and 18 after the beginning of the study to quantify uremic toxin Cyanate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • prevalent patients in tertiary nephrology clinic;
  • patients over 18 years;
  • CKD stage 3b-4 (eGFR between 15 and 45 ml/min/1.73m2, estimated by MDRD formula);
  • clinically proven adherence to prescribed therapies;
  • informed consent signed.

Exclusion Criteria:

  • change of GFR >30% within the last 3 months;
  • acute, intercurrent disease during the previous 3 months;
  • severe undernutrition as indicated by: BMI < 20 kg/m2 and serum albumin < 3.2 g/dl, or BMI < 17.5 kg/m2 whatever albumin value, or body weight reduction > 5% within the last month or > 10% within the last six months;
  • pregnancy or feeding;
  • chronic treatment with steroid or cytotoxic drugs; fast progressing glomerulonephritis; active SLE and vasculitis;
  • gastrointestinal diseases (Crohn disease, Ulcerative colitis, Celiac Sprue, Stypsis); 7) infectious diseases; 8) cardiac failure stage III-IV NYHA; advanced liver cirrhosis; active cancer diseases; severe encephalopathy associated with lack of spontaneous feeding; chronic obstructive respiratory diseases needing oxygen treatment; 9) use of antibiotics or probiotics until 15 days before the enrolment; 10) psychiatric disease or inability to assess follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302287


Locations
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Italy
UOC Nefrologia
Solofra, Avellino, Italy, I-83029
Sponsors and Collaborators
Azienda Sanitaria ASL Avellino 2
Investigators
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Principal Investigator: Biagio Raffaele Di Iorio, PI Azienda Sanitaria ASL Avellino 2

Publications:

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Responsible Party: Dr Biagio Di Iorio, Chair of Nephrology Departement, Azienda Sanitaria ASL Avellino 2
ClinicalTrials.gov Identifier: NCT02302287    
Other Study ID Numbers: rf 2013-02355394
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: January 2016
Keywords provided by Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2:
Chronic kidney disease
mediterranean diet
low-protein diet
ketoacids
intestinal microbiota
Additional relevant MeSH terms:
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Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents