Methods |
Parallel RCT (double‐blind) |
Participants |
HD patients |
Interventions |
Oral nutritional supplement specifically developed for undernourished HD patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants and carnitine), with probiotics |
Outcomes |
Nutritional status: anthropometric measurements, handgrip strength measured by a Jamar hand dynamometer, body composition assessed by bioelectrical impedance analysis, and a 5‐day dietary record
Functional status assessed by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire"
QoL assessed by the "12‐item short form health survey", and the presence of symptoms of depression and anxiety by the "Hospital Anxiety and Depression Scale"
Inflammatory markers
Oxidative markers
Gut microbiota
Circulating miRNAs and the expression of it's target genes on cells
|
Notes |
Protocol registration only; current status is completed, the results is unknown |