ISRCTN ISRCTN64383094
DOI https://doi.org/10.1186/ISRCTN64383094
Secondary identifying numbers N/A
Submission date
18/01/2013
Registration date
21/02/2013
Last edited
22/06/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Giacomo Garibotto
Scientific

Viale Benedetto xv
Genoa
16132
Italy

Email gari@unige.it

Study information

Study designNon-randomized prospective self-controlled crossover trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffects 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
Study acronymPMCKD
Study objectivesThe 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(s)IRCCS Azienda Ospedaliera Universitaria “San Martino”- IST Istituto Nazionale per la Ricerca sul Cancro, 13/04/2012, ref: 7/2012
Health condition(s) or problem(s) studiedChronic kidney disease
InterventionLow 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 typeOther
Primary outcome measureProtein metabolism measured at baseline and at the end of each six-week experimental period
Secondary outcome measuresSerum/muscle myostatin measured at baseline and at the end of each six-week experimental period
Overall study start date10/01/2013
Completion date06/06/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit79 Years
SexBoth
Target number of participants20
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment10/01/2013
Date of final enrolment06/06/2014

Locations

Countries of recruitment

  • Italy

Study participating centre

Viale Benedetto xv
Genoa
16132
Italy

Sponsor information

Fresenius Kabi Deutschland GmbH (Germany)
Industry

Else-Kröner-Str.1
Bad Homburg
61346
Germany

Email Anja.Markant@fresenius-kabi.com
Website http://www.fresenius-kabi.com/
ROR logo "ROR" https://ror.org/01v376g59

Funders

Funder type

Industry

Fresenius Kabi (Germany) - Ketosteril Award

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

22/06/2017: Plain English summary added.