Plain English Summary
Background and study aims
Protein-energy wasting (PEW) is common in patients with chronic kidney disease. It is a condition where the body has decreased stores of protein and energy and is associated with an increased risk of death. The aim of this study is to investigate the response to a low protein diet and a keto/amino acid supplemented very low protein diet in patients with chronic kidney disease.
Who can participate?
Patients aged 18 to 79 with chronic kidney disease
What does the study involve?
The study is composed of two different studies. In study A participants eat a usual-protein diet followed by a low-protein diet to find out how skeletal muscle protein turnover adapts. Study B consists of four six-week periods: the enrollment period, a low-protein diet period, a keto/amino acid supplemented very low protein diet period, and another low-protein diet period. Protein turnover (both whole body and muscle) is measured at the start of the study and at the end of each six-week period.
What are the possible benefits and risks of participating?
The study provides new information on how the body adapts to a low protein diet, and may be helpful for the understanding of their nutritional safety. The study involves the use of stable isotopes of naturally occurring amino acids, a procedure which is not harmful. The possible risks of measuring muscle protein turnover are those related to cannulation (where a tube is inserted into a blood vessel).
Where is the study run from?
Università degli studi di Genova (Italy)
When is the study starting and how long is it expected to run for?
January 2013 to June 2014
Who is funding the study?
Fresenius Kabi (Germany)
Who is the main contact?
Prof. Giacomo Garibotto
gari@unige.it
Trial website
Contact information
Type
Scientific
Primary contact
Prof Giacomo Garibotto
ORCID ID
Contact details
Viale Benedetto xv
Genoa
16132
Italy
-
gari@unige.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of a low protein diet and of a keto/amino acid supplemented very low protein diet on muscle protein metabolism and myostatin in patients with chronic kidney disease
Acronym
PMCKD
Study hypothesis
The hypothesis is that the use of keto/amino acid supplements may partially or totally reverse the abnormal amino acid metabolism thus counteracting the uremia-related muscle cell loss and catabolic events.
Ethics approval
IRCCS Azienda Ospedaliera Universitaria San Martino- IST Istituto Nazionale per la Ricerca sul Cancro, 13/04/2012, ref: 7/2012
Study design
Non-randomized prospective self-controlled crossover trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic kidney disease
Intervention
Low protein diet or supplemented very low protein dieT (vLPD)
The research protocol is composed of two different studies:
Study A: to determine how skeletal muscle protein metabolism adapt to a low protein diet, forearm protein turnover will be evaluated in the same CKD patients assigned to a usual-protein diet (1.1 g/kg/day, 30-35 kcalday), followed by a low-protein diet (LPD) (0.8 g/kg, followed by 0.55 g/kg, 30-35 kcal/Kg/day). Each time period of study is 6 weeks, with total length of period of time during which patient will be followed up of 18-24 weeks. To determine the muscle responses to a supplemented vLPD (0,45 g/kg, supplemented with 0.1 g/kg Ketosteril, 30-35 kcal/Kg/day)
Study B: protein turnover (both whole body and muscle), muscle and plasma myostatin, muscle apoptosis, muscle proteolytic-related genes and intracellular insulin signaling, will be studied in a prospective cross-over trial with CKD patients serving as their own controls. Study B consists of four six-week consecutive periods: the enrollment period, the baseline (LPD) period, the treatment period (supplemented protein-restricted, vLPD) and the wash-out LPD period .
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Protein metabolism measured at baseline and at the end of each six-week experimental period
Secondary outcome measures
Serum/muscle myostatin measured at baseline and at the end of each six-week experimental period
Overall trial start date
10/01/2013
Overall trial end date
06/06/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18-79, both males and females
2. Non-diabetic CKD (Stages 4-5, estimated glomerular filtration rate [eGFR] 12-25 ml/min)
3. Compliance to treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Evidence of congestive heart failure
2. Incapable of following study requirements to control diet
3. A recent myocardial infarction
4. Pregnancy
5. Unstable renal function
6. Recent (<3 months) infection history
7. Clinical evidence of gastrointestinal or liver diseases
8. Alcoholism
9. Drug abuse
10. Final diagnosis of malignancy
Recruitment start date
10/01/2013
Recruitment end date
06/06/2014
Locations
Countries of recruitment
Italy
Trial participating centre
Viale Benedetto xv
Genoa
16132
Italy
Sponsor information
Organisation
Fresenius Kabi Deutschland GmbH (Germany)
Sponsor details
Else-Kröner-Str.1
Bad Homburg
61346
Germany
-
Anja.Markant@fresenius-kabi.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Fresenius Kabi (Germany) - Ketosteril Award
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary