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

Sarcopenia Clinical Trial

— ALTIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223206
• Other study ID #: K2DTD75_ALTISnefro
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: January 2021
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis
• Sarcopenia

Intervention

Dietary Supplement:
• NATURLENS
Oral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water

Locations

Country	Name	City	State
Italy	AOUConsorziale Policlinico Di Bari	Bari

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	University of Bari Aldo Moro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiota	Change of the relative abundance (%) of Operational Taxonomic Units (OTUs) of Firmicutes, Bacteroidetes,Proteobacteria, Verrucomicrobia, Actinobacteria, Synergistetes, Cyanobacteria, Euryarchaeota, Chloroflexi, Nitrospirae, Tenericutes, Fusobacteria, Thermotogae, Acidobacteria evaluated by fecal bacterial DNA genome sequencing.	3 months
Primary	Evaluation of muscle mass	Change of muscle mass by bioelectrical impedance assessment (BIA)	3 months
Secondary	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
Secondary	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
Secondary	Change of anthropometric parameter	Measurement of the arm circumference (cm)	3 months
Secondary	Change of body mass index (BMI)	Measurement of BMI (kg/m^2)	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of serum concentration of inflammatory markers	Change of serum concentrations of interleukins: IL-6, TNF-a, IL-1, IL-8, IL-10 (pg/mL) evaluated by ELISA	3 months
Secondary	Change of blood glucose level	Change of glycemia concentration (mg/dl)	3 months
Secondary	Change of insulin levels	Change of insulin concentration (pmol/L)	3 months
Secondary	Change of endocrine parameters	Change of C-peptide, growth hormone (GH), insulin-like growth factor 1 (IGF-1), testosterone concentration (ng/mL)	3 months
Secondary	Change of serum concentration of D-lactate	Change of D-lactate serum concentration (uM)	3 months