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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status

Completed

Conditions

Hemodialysis

Sarcopenia

Treatments

Dietary Supplement: NATURLENS

Study type

Interventional

Funder types

Other

Identifiers

NCT04223206

K2DTD75_ALTISnefro

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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