Condition category
Urological and Genital Diseases
Date applied
18/01/2013
Date assigned
21/02/2013
Last edited
22/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.fresenius-kabi.com/

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

Publication citations

Additional files

Editorial Notes

22/06/2017: Plain English summary added.