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

NCT ID: NCT04223206

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-03-01

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

Conditions

Hemodialysis; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemodialysis with sarcopenia

10 HD patients, affected by sarcopenia will a undergo 3-months supplementation with NATURLENS

Group Type: EXPERIMENTAL

NATURLENS

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water

Controls

10 HD patients, affected by sarcopenia will be followed for 3 months without any supplementation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NATURLENS

Oral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bari Aldo Moro

OTHER

Sponsor Role: collaborator

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loreto Gesualdo, MD Full Prof

Role: PRINCIPAL_INVESTIGATOR

Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari

Locations

AOUConsorziale Policlinico Di Bari

Bari, , Italy

Countries

Italy

Other Identifiers

K2DTD75_ALTISnefro

Identifier Type: -

Identifier Source: org_study_id