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

Primary Purpose

Hemodialysis, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
NATURLENS
Sponsored by
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis focused on measuring uremic toxins, gut microbiota dysbiosis, sarcopenia, hemodialysis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AOUConsorziale Policlinico Di Bari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hemodialysis with sarcopenia

Controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

Evaluation of muscle mass
Change of muscle mass by bioelectrical impedance assessment (BIA)

Secondary Outcome Measures

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).
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)
Change of anthropometric parameter
Measurement of the arm circumference (cm)
Change of body mass index (BMI)
Measurement of BMI (kg/m^2)
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).
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).
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
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
Change of blood glucose level
Change of glycemia concentration (mg/dl)
Change of insulin levels
Change of insulin concentration (pmol/L)
Change of endocrine parameters
Change of C-peptide, growth hormone (GH), insulin-like growth factor 1 (IGF-1), testosterone concentration (ng/mL)
Change of serum concentration of D-lactate
Change of D-lactate serum concentration (uM)

Full Information

First Posted
December 17, 2019
Last Updated
February 2, 2023
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborators
University of Bari Aldo Moro
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1. Study Identification

Unique Protocol Identification Number
NCT04223206
Brief Title
Innovative Functional Food Based on Apulian Lens Culinaris for Contrasting Sarcopenia in Dialysis Patients
Acronym
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"
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborators
University of Bari Aldo Moro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Sarcopenia
Keywords
uremic toxins, gut microbiota dysbiosis, sarcopenia, hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemodialysis with sarcopenia
Arm Type
Experimental
Arm Description
10 HD patients, affected by sarcopenia will a undergo 3-months supplementation with NATURLENS
Arm Title
Controls
Arm Type
No Intervention
Arm Description
10 HD patients, affected by sarcopenia will be followed for 3 months without any supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
NATURLENS
Intervention Description
Oral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water
Primary Outcome Measure Information:
Title
Evaluation of muscle mass
Description
Change of muscle mass by bioelectrical impedance assessment (BIA)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of sarcopenia conditions
Description
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).
Time Frame
3 months
Title
Change of Mini Nutritional Assessment (MNA) score
Description
Measurement of MNA questionnaire (12-14 points, normal nutritional status; 8-11 points, at risk of malnutrition; 0-7, malnourished)
Time Frame
3 months
Title
Change of anthropometric parameter
Description
Measurement of the arm circumference (cm)
Time Frame
3 months
Title
Change of body mass index (BMI)
Description
Measurement of BMI (kg/m^2)
Time Frame
3 months
Title
Change of gastrointestinal symptoms
Description
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).
Time Frame
3 months
Title
Change of stool type
Description
Change of stool type evaluated by BRISTOL Stool Scale (range 1-7, lower and higher values representing worse outcome, middle values representing better outcome).
Time Frame
3 months
Title
Change of serum concentration of IS and pCS
Description
Change of free and total indoxyl sulfate (IS) and p-cresyl sulfate (pCS) serum concentrations (μg/mL) assessed by liquid chromatography/mass spectrometry
Time Frame
3 months
Title
Change of serum concentration of inflammatory markers
Description
Change of serum concentrations of interleukins: IL-6, TNF-α, IL-1, IL-8, IL-10 (pg/mL) evaluated by ELISA
Time Frame
3 months
Title
Change of blood glucose level
Description
Change of glycemia concentration (mg/dl)
Time Frame
3 months
Title
Change of insulin levels
Description
Change of insulin concentration (pmol/L)
Time Frame
3 months
Title
Change of endocrine parameters
Description
Change of C-peptide, growth hormone (GH), insulin-like growth factor 1 (IGF-1), testosterone concentration (ng/mL)
Time Frame
3 months
Title
Change of serum concentration of D-lactate
Description
Change of D-lactate serum concentration (uM)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Gut microbiota
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loreto Gesualdo, MD Full Prof
Organizational Affiliation
Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOUConsorziale Policlinico Di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy

12. IPD Sharing Statement

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

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