Innovative Functional Food Based on Apulian Lens Culinaris for Contrasting Sarcopenia in Dialysis Patients

Study Overview
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Brief Summary
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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

Official Title
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K2DTD75 - ALTIS Alimento Funzionale a Base di Lens Culinaris Tipico Del Territorio Pugliese ed Innovativo Per la Salute - Regione Puglia INNONETWORK 2017

Conditions
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Hemodialysis, Sarcopenia

Intervention / Treatment
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* Dietary Supplement: NATURLENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients > 60 years old omnivore controlled normocaloric diet (30 Kcal/kg ideal weight) patients with chronic kidney disease (CKD) and routine hemodialysis or peritoneal dialysis patients with primary sarcopenia identified with score ≥ 4 at SARC-F Questionnaire informed consent signed Exclusion Criteria: participation to another clinical trial limb removal by amputation altered blood sugar level (HbA1c>8.0%) or type I diabetes mellitus neoplastic events in the last 5 years gut, systemic or autoimmune chronic inflammatory pathologies use of antibiotics or probiotics up to 30 days prior to recruitment life expectancy of less than one year treatment with corticosteroids or immunosuppressive drugs (excluded prednisone at dose <5 mg at day) positivity to hepatitis B and C virus, HIV1/2 and syphilis oxygen saturation in the blood at rest <93% alcohol or drug abuse in the last 3 years clinically important alterations of the following laboratory parameters: hemoglobin <9.0 g / dL, white blood cells <2.500 / μl, platelet count <100.000 / μl, AST and ALT> 3 times the upper limit of the norm, coagulopathy (INR> 1.3 ) not due to a reversible cause (eg Warfarin and / or factor Xa inhibitors) uncontrolled hypertension (resting systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg) unstable angina pectoris, severe peripheral artery disease, coronary bypass surgery, angioplasty or acute major cardiocirculatory diseases in the previous 3 months definite congestive heart failure class III or IV (NYHS) or ejection fraction <25% severe pulmonary dysfunction: acute exacerbation of chronic obstructive pulmonary disease in phase III or IV (Gold classification) and / or PaO2 levels <60 mmHg significant intestinal malabsorption due to partial ileal bypass or other causes score ≤ 24 at the Mini Mental State Examination (MMSE) or presence of cognitive or linguistic limits that prohibit informed consent or possible elements of study diagnosis of disabling neurological disorder, including Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (for example, muscle weakness or gait disorder), dementia or any psychiatric condition that reduces protocol compliance have a history or evidence of any condition, therapy, laboratory abnormality or other circumstances that could confuse the results of the study or interfere with the patient's participation throughout the duration of the study

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemodialysis with sarcopenia<br>10 HD patients, affected by sarcopenia will a undergo 3-months supplementation with NATURLENS | Dietary Supplement: NATURLENS<br>* Oral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water<br>|
| No Intervention: Controls<br>10 HD patients, affected by sarcopenia will be followed for 3 months without any supplementation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of muscle mass | Change of muscle mass by bioelectrical impedance assessment (BIA) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 3 months | 
| Change of anthropometric parameter | Measurement of the arm circumference (cm) | 3 months | 
| Change of body mass index (BMI) | Measurement of BMI (kg/m^2) | 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). | 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). | 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 | 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 | 3 months | 
| Change of blood glucose level | Change of glycemia concentration (mg/dl) | 3 months | 
| Change of insulin levels | Change of insulin concentration (pmol/L) | 3 months | 
| Change of endocrine parameters | Change of C-peptide, growth hormone (GH), insulin-like growth factor 1 (IGF-1), testosterone concentration (ng/mL) | 3 months | 
| Change of serum concentration of D-lactate | Change of D-lactate serum concentration (uM) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uremic toxins, gut microbiota dysbiosis, sarcopenia, hemodialysis