Clinical trial NCT04223206: Innovative Functional Food Based on Apulian Lens Culinaris for Contrasting Sarcopenia in Dialysis Patients
Official title: K2DTD75 - ALTIS "Alimento Funzionale a Base di Lens Culinaris Tipico Del Territorio Pugliese ed Innovativo Per la Salute" - Regione Puglia "INNONETWORK 2017"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Sarcopenia
Keywords: uremic toxins
gut microbiota dysbiosis
sarcopenia
hemodialysis
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
Collaborators: name: University of Bari Aldo Moro
First posted: 2020-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of muscle mass
timeFrame: 3 months
Secondary outcomes:
measure: Change of sarcopenia conditions
timeFrame: 3 months
measure: Change of Mini Nutritional Assessment (MNA) score
timeFrame: 3 months
measure: Change of anthropometric parameter
timeFrame: 3 months
measure: Change of body mass index (BMI)
timeFrame: 3 months
measure: Change of gastrointestinal symptoms
timeFrame: 3 months
measure: Change of stool type
timeFrame: 3 months
measure: Change of serum concentration of IS and pCS
timeFrame: 3 months
measure: Change of serum concentration of inflammatory markers
timeFrame: 3 months
measure: Change of blood glucose level
timeFrame: 3 months
measure: Change of insulin levels
timeFrame: 3 months
measure: Change of endocrine parameters
timeFrame: 3 months
measure: Change of serum concentration of D-lactate
timeFrame: 3 months
Other outcomes:
measure: Gut microbiota
timeFrame: 3 months
Locations:
city: Bari
country: Italy
facility: AOUConsorziale Policlinico Di Bari
Study officials:
affiliation: Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
name: Loreto Gesualdo, MD Full Prof
role: PRINCIPAL_INVESTIGATOR
References: