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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Hemodialysis; Sarcopenia
• Intervention / Treatment: Dietary supplement: NATURLENS

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • AOUConsorziale Policlinico Di Bari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Collaborators: University of Bari Aldo Moro

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 15, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: sarcopenia; hemodialysis; uremic toxins; gut microbiota dysbiosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: K2DTD75_ALTISnefro

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No