HemodialysisALTISNCT04223206
Innovative Functional Food Based on Apulian Lens Culinaris for Contrasting Sarcopenia in Dialysis Patients
A study testing NATURLENS in people with Hemodialysis and Sarcopenia, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hemodialysis, Sarcopenia
- What is being tested?
- NATURLENS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Hemodialysis, Sarcopenia
- Being tested
- NATURLENS
- Keywords
- uremic toxins, gut microbiota dysbiosis, sarcopenia, hemodialysis
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NATURLENSDietary supplement
Oral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis with sarcopenia | Experimental | 10 HD patients, affected by sarcopenia will a undergo 3-months supplementation with NATURLENS Receives: Dietary Supplement: NATURLENS |
| Controls | No intervention | 10 HD patients, affected by sarcopenia will be followed for 3 months without any supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of muscle mass
Change of muscle mass by bioelectrical impedance assessment (BIA)
Measured: 3 months
Secondary outcomes (12)
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).
Measured: 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)
Measured: 3 months
Change of anthropometric parameter
Measurement of the arm circumference (cm)
Measured: 3 months
Change of body mass index (BMI)
Measurement of BMI (kg/m^2)
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 3 months
Change of blood glucose level
Change of glycemia concentration (mg/dl)
Measured: 3 months
Change of insulin levels
Change of insulin concentration (pmol/L)
Measured: 3 months
Change of endocrine parameters
Change of C-peptide, growth hormone (GH), insulin-like growth factor 1 (IGF-1), testosterone concentration (ng/mL)
Measured: 3 months
Change of serum concentration of D-lactate
Change of D-lactate serum concentration (uM)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Dec 2020
- Primary completion15 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Responsible party
- Sponsor
- Investigators
- Loreto Gesualdo, MD Full Prof, Principal investigator, Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223206
- Sponsor's protocol ID
- K2DTD75_ALTISnefro
- Acronym
- ALTIS
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2019
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- K2DTD75 - ALTIS "Alimento Funzionale a Base di Lens Culinaris Tipico Del Territorio Pugliese ed Innovativo Per la Salute" - Regione Puglia "INNONETWORK 2017"
- ClinicalTrials.gov ID
- NCT04223206
- Acronym / sponsor ID
- ALTIS / K2DTD75_ALTISnefro
- Conditions
- Hemodialysis, Sarcopenia
- Keywords
- uremic toxins, gut microbiota dysbiosis, sarcopenia, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis with sarcopenia | Experimental | Dietary Supplement: NATURLENS10 HD patients, affected by sarcopenia will a undergo 3-months supplementation with NATURLENS |
| Controls | No intervention | –10 HD patients, affected by sarcopenia will be followed for 3 months without any supplementation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NATURLENSOral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water | Dietary supplement | Hemodialysis with sarcopenia |
Primary outcome
Evaluation of muscle mass
Time frame: 3 months
Change of muscle mass by bioelectrical impedance assessment (BIA)
12 secondary outcomes
Change of sarcopenia conditions
Time frame: 3 months
Change of Mini Nutritional Assessment (MNA) score
Time frame: 3 months
Change of anthropometric parameter
Time frame: 3 months
Change of body mass index (BMI)
Time frame: 3 months
Change of gastrointestinal symptoms
Time frame: 3 months
Change of stool type
Time frame: 3 months
Change of serum concentration of IS and pCS
Time frame: 3 months
Change of serum concentration of inflammatory markers
Time frame: 3 months
Change of blood glucose level
Time frame: 3 months
Change of insulin levels
Time frame: 3 months
Change of endocrine parameters
Time frame: 3 months
Change of serum concentration of D-lactate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loreto Gesualdo, MD Full Prof principal investigator
Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NATURLENS in people with Hemodialysis and Sarcopenia, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of muscle mass (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.