The objective of the pilot study is to validate the clinical use of a dietary supplement for contrasting sarcopenia in dialysis patients. The study aims at evaluating the effects of a nutritional supplement, consisting of flour from Lens culinaris of Altamura IGP, pea proteins and vitamins (A, B12, D, E) by achieving the following objectives: * Reduction of sarcopenia conditions, through improvement of nutritional and anthropometrical levels * Decrease of the serum levels of microbiota-derived uremic toxins * Reduction of intestinal permeability and inflammatory markers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Oral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water
AOUConsorziale Policlinico Di Bari
Bari, Italy
Evaluation of muscle mass
Change of muscle mass by bioelectrical impedance assessment (BIA)
Time frame: 3 months
Change of sarcopenia conditions
Change of sarcopenia assessed by the European Working Group on Sarcopenia in Older People (EWGSOP) guidelines through the SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls) questionnaire. The SARC-F scale scores range from 0 to 10 (i.e. 0-2 points for each item; 0=best to 10=worst) and represents no sarcopenia (0-3) and sarcopenia (4-10).
Time frame: 3 months
Change of Mini Nutritional Assessment (MNA) score
Measurement of MNA questionnaire (12-14 points, normal nutritional status; 8-11 points, at risk of malnutrition; 0-7, malnourished)
Time frame: 3 months
Change of anthropometric parameter
Measurement of the arm circumference (cm)
Time frame: 3 months
Change of body mass index (BMI)
Measurement of BMI (kg/m\^2)
Time frame: 3 months
Change of gastrointestinal symptoms
Change of gastrointestinal symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (15 items scored 1-7 each, 1 representing the best and 7 the worse outcome for each item).
Time frame: 3 months
Change of stool type
Change of stool type evaluated by BRISTOL Stool Scale (range 1-7, lower and higher values representing worse outcome, middle values representing better outcome).
Time frame: 3 months
Change of serum concentration of IS and pCS
Change of free and total indoxyl sulfate (IS) and p-cresyl sulfate (pCS) serum concentrations (μg/mL) assessed by liquid chromatography/mass spectrometry
Time frame: 3 months
Change of serum concentration of inflammatory markers
Change of serum concentrations of interleukins: IL-6, TNF-α, IL-1, IL-8, IL-10 (pg/mL) evaluated by ELISA
Time frame: 3 months
Change of blood glucose level
Change of glycemia concentration (mg/dl)
Time frame: 3 months
Change of insulin levels
Change of insulin concentration (pmol/L)
Time frame: 3 months
Change of endocrine parameters
Change of C-peptide, growth hormone (GH), insulin-like growth factor 1 (IGF-1), testosterone concentration (ng/mL)
Time frame: 3 months
Change of serum concentration of D-lactate
Change of D-lactate serum concentration (uM)
Time frame: 3 months
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