Medika Study
Networks
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Datasets
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Variables
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Nutritional terapy impact on intestinal microbiota and Chronic Kidney
Disease
- Start Year
- 2015
- End Year
- 2019
- Funding
- Italian Society of Nephrology
| Investigators | Contacts |
|---|---|
|
Design
- Study design
- Cohort
- Follow Up
- yes, Baseline +3 month First dietary intervention +9 months Wash out +12 months Secondary dietary intervention +18 months
- Supplementary Information
- Effects of MD (medieterranean diet) and VLPD (very low protein diet) on the modulation of intestinal microbiota and, consequently, on the variation of serum indoxyl sulfate (IS) and p-cresyl sulfate (PCS) levels in patients with CKD were evaluated.
Marker Paper
Di Iorio BR, Rocchetti MT, De Angelis M, Cosola C, Marzocco S, Di Micco L, di Bari I, Accetturo M, Vacca M, Gobbetti M, Di Iorio M, Bellasi A, Gesualdo L. Nutritional Therapy Modulates Intestinal Microbiota and Reduces Serum Levels of Total and Free Indoxyl Sulfate and P-Cresyl Sulfate in Chronic Kidney Disease (Medika Study). J Clin Med. 2019 Sep 10;8(9):1424.
PUBMED doi: 10.3390/jcm8091424.
Recruitment
- Sources of Recruitment
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- Individuals
Number of participants
- Number of participants
- 60
- Number of participants with biosamples
- 60
- Supplementary Information
- Each participant followed three different dietary intervention. FD = free diet, VLPD = very low protein diet, MD = Mediterranean diet
Timeline
medika-study
Selection Criteria
- Minimum age
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56
- Maximum age
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80
- Newborns
- Twins
- Countries
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- Italy
- Territory
- Italy
- International/National/Regional (region name)
- Azienda Sanitaria ASL Avellino 2
- Ethnic Origin
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- Caucasian
- Health Status
-
Recruitment
- Sources of recruitment
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- Specific population
- Other : study on patients belonging to nephrology, dialysis and transplantation section of Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari
- Specific Population
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- Clinic patients
Number of participants
- Number of participants
- 60
- Number of participants with biosamples
- 60
- Supplementary Information
- Each participant followed three different dietary interventions
Data Collection Event
The trial with MD and very low protein diet (VLPD) diets has been successful in modulating intestinal microbiota and in reducing the protein-bound uremic toxin production rate in CKD patients.
- Start Date
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2015
- End Date
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2019
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Measurements & methods
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Dietary intake
- yes/no
-
- Information collected on habitual food intake collected
- Information collected on type of diet (vegetarian/vegan/omnivore)
- Special dietary aspects collected (e.g. supplements, probiotics, prebiotics and synbiotics)
- Methods
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- Other methods
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Other methods
- Other methods
- Nutritional therapy adherence was evaluated by dietary interviews completed by patients for a full week every two months and by photos of the dishes they would eat
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Anthropometric measurements
- Weight/height
- Measured
- Waist/hip circumference
- Other measurements
- Body mass index
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Sociodemographic information
- Information collected
- Sex, age
- Administration method
- Face-to-face interview
- Administration type
- Paper-based
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Medication
- Questionnaire name/set of questions
- Set of questions
- Antibiotics
- Last treatment
- Administration method
- Face-to-face interview
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Health status
- Information collected
- Disease: Chronic kidney disease
- Questionnaire name/set of questions
- Medical records
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Biological samples and laboratory measurements
- Samples collected
- Feaces, blood and urine
- Number of samples
- Whole set
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Biomarkers
-
Lipids
- Measurement(s)
- Cholesterol, triglicerids
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Glucose
- Measurement(s)
- Glycemia, HbA1c
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Inflammation markers
- Measurement(s)
- Protein c reactive
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Metabolomics
- Measurement(s)
- Urinary natrium, Urinary potassium ,Urinary phosphate, urinary urea nitrogen, Uremic toxins (
- Medium
- Urines
- Untargeted approach
- yes
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Microbiome
- Microbial material
- 16S rDNA Illumina Miseq
- Number of samples/number of individuals
-
27
- Library source and library selection
- Targeted metagenomes 16S
- Medium/tissue
- Faeces
- Sampling collection method
- Faecal devices
- Time spent in room temperature
- No time spent in room temperature
- Sequencing platform
- Illumina Miseq
- Read length/depth
- 2 X 300bp
- Further details
- Amplicon sequencing of prokaryotic 16S small subunit rRNA genes - V3-V4 region
- Preservation method
- "-20°C"
- Preservation buffer
- Immediately placed into device containing RNAlater solution
- Information on type of meal last eaten prior to sample extraction available
- no