Renal DiseaseNCT04208451
The Effects of One Month Consumption of Standardized Aronia Melanocarpa Extract on Anemia in Patients on Hemodialysis
A study testing Alixir 400 Protect in people with Renal Disease and Dialysis; Complications, run by University of Kragujevac at 1 site in Serbia.
Trial summary
In this study are included patients on hemodialysis with anemia (levels of Hemoglobin<110). After baseline measurements tha patients take Standardized Aronia melanocarpa extract for one mont and then all measurements were repeated. Read more about this study
- Who is it for?
- Ages 37 to 68 years
- Conditions the study is for
- Renal Disease, Dialysis; Complications, Anemia
- What is being tested?
- Alixir 400 Protect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Aug 2019to 1 Oct 2019
- 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 37 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- regular dialysis treatment for more than 3 months, 3 times a week
- hemoglobin values lower than 110g / L
Who cannot join
- hemoglobin values lower than 80g/L,
- the use of antioxidant and immunosuppressive therapy,
- uncontrolled malignancies,
- proven active bleeding
- presence of systemic inflammation or active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of One Month Consumption of Standardized Aronia Melanocarpa Extract on Anemia in Patients on Hemodialysis: Focus on Oxidative Stress and Inflammation
In this study are included patients on hemodialysis with anemia (levels of Hemoglobin<110). After baseline measurements tha patients take Standardized Aronia melanocarpa extract for one mont and then all measurements were repeated.
Read the detailed description
- Patients The study included 30 patients with chronic kidney failure on dialysis treatment at the Center for Nephrology and Dialysis of the Clinical Center Kragujevac. Inclusion criteria were: regular dialysis treatment for more than 3 months, 3 times a week and hemoglobin values lower than 110g / L. Exclusion criteria were: hemoglobin values lower than 80g/L, the use of antioxidant and immunosuppressive therapy, uncontrolled malignancies, proven active bleeding and presence of systemic inflammation or active infection.
- Ethical approval The research was conducted with respect to the Helsinki Declaration on Medical Research, the approval of the Ethics Committee of the Clinical Center Kragujevac No 01-14-3039. All subjects provided written informed consent before study enrollment.
- Used plant extract Standardized Aronia extract (SAE) is official product of pharmaceutical company Pharmanova (Belgrade, Serbia); nevertheless, procedure of extraction was done by EU-Chem company (Belgrade, Serbia). This product contains 400mg/30ml of polyphenols, while the recommended daily dosage is 30ml.
- Blood sampling Patients included in the study consumed standardized Aronia melanocarpa extract (30ml/day) for 30 days. On the day 0, before SAE consumption, blood samples from all patients were collected for hematologic analyzes, inflammation parameters, oxidative stress parameters and antioxidant protection before the dialysis procedure. All mentioned parameters were determined again after consuming the product, ie. on the 30th day of the study.
- Analytic Procedures Venous blood samples (2 x 4.5ml) were taken before the start of supplementation (zero day) and at the end of supplementation (30th day). Vacuum tubes with sodium citrate were used for blood sampling. The first sample was used for routine hematologic analyzes, the second sample was used for plasma and erythrocyte lysate extraction in order to determinate redox and inflammatory status.
- Evaluation of Systemic Redox State Plasma samples were used for determination of the levels of the following pro-oxidants: superoxide anion radical (O2-), hydrogen peroxide (H2O2), nitrites (NO2-) and index of lipid peroxidation measured as thiobarbituric acid reactive substances (TBARS), while the parameters of antioxidative defence system, such as activities of superoxide dismutase (SOD) and catalase (CAT) and level of reduced glutathione (GSH) were determined in erythrocytes lysates samples.
- Index of lipid peroxidation (TBARS) determination The degree of lipid peroxidation in the plasma samples was estimated by measuring TBARS, using 1% thiobarbituric acid in 0.05 NaOH, which was incubated with the sample at 100°C for 15 min and measured at 530 nm. TBA extract was obtained by combining 0.8 ml sample and 0.4 ml trichloro acetic acid (TCA); afterwards, the samples were put on ice for 10 min and centrifuged for 15 min at 6000 rpm. (1).
- Nitrite determination (NO2-) Nitric oxide (NO) decomposes rapidly to form stable nitrite/nitrate products. The NO2- level was measured and used as an index of NO production, using Griess's reagent. For NO2 - determination in plasma 0.1 ml 3 N PCA (perchloride acid), 0.4 ml 20 mM ethylenediaminetetraacetic acid (EDTA) and 0.2 ml plasma were put on ice for 15 min, then centrifuged for 15 min at 6000 rpm. After pouring off the supernatant, 220 μl K2CO3 was added. Nitrites were measured at 550 nm. (2)
- Superoxide anion radical determination (O2-) Superoxide anion radical concentrations in plasma samples were measured using the NTB (Nitro Blue Tetrazolium) reagent in TRIS buffer (assay mixture). The measurement was performed at a wavelength of 530 nm. (3).
- Hydrogen peroxide determination (H2O2) The measurement of H2O2 was based on the oxidation of phenol red by H2O2 in a reaction catalyzed by horseradish peroxidase. Two hundred microlitres of perfusate or plasma was precipitated using 800 mL of freshly prepared phenol red solution; 10 μL of (1:20) horseradish peroxidase (made immediately before use) was subsequently added. The level of H2O2 was measured at 610 nm (4).
- Determination of reduced glutathione (GSH) The level of reduced glutathione (GSH) was determined based on GSH oxidation via 5,5-dithiobis-6,2-nitrobenzoic acid. GSH extract was obtained by combining 0.1 ml 0.1% EDTA, 400 μl hemolysate, and 750 μl precipitation solution (containing 1.67 g metaphosphoric acid, 0.2 g EDTA, 30 g NaCl, and filled with distilled water until 100 ml; the solution is stable for 3 weeks at +4C°). The level of GSH was measured at 420 nm (5).
- Determination of antioxidant enzymes (SOD, CAT) Isolated RBCs were washed three times with three volumes of ice-cold 0.9 mmol/l NaCl, and hemolysates containing about 50 g Hb/l were used for the determination of CAT activity. CAT buffer, prepared hemolysate sample, and 10 mM H2O2 were used for CAT determination. Detection was performed at 360 nm. SOD activity was determined by the epinephrine method. Hemolysate was mixed with carbonate buffer, and then epinephrine was added. Detection was performed at 470 nm (6-10).
- Evaluation of the inflammatory status In order to evaluate the inflammatory status of patients, following parameters were measured at both points of interest (0 and 30th day): serum C-reactive protein concentration - CRP and tumor necrosis factor concentration - TNF-α. The serum C- reactive protein (CRP) concentration was determined by the turbidimetric method on the Olympus AU680. The normal serum CRP concentration is ≤ 5 mg/L. Microinflammation is defined as the concentration of CRP in the serum of 5 mg/L. Plasma TNF-α concentrations were determined by enzyme linked immunoadsorbent assay (ELISA) using commercially available high sensitivity indirect sandwich enzyme-linked immunosorbent assay (Sigma Aldrich).
- Evaluation of the hematological parameters At both points of interest, the values of the following haematological parameters in all patients were analyzed: Erythrocytes (Er), hemoglobin (Hb), hematocrit (Hct), erythrocyte index- mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), serum lactate dehydrogenase concentration (LDH), serum haptoglobin concentration and iron status: serum iron concentration, ferritin; total iron binding capacity (TIBC), unsaturated iron binding capacity (UIBC), transferrin saturation (TSAT), haptoglobin.
- Statistical Analysis IBM SPSS Statistics 20.0 Desktop for Windows was used for statistical analysis. Shapiro-Wilk test was used to check the distribution of data. Statistical comparisons were performed using the one-way analysis of variance (ANOVA) tests with a Tukey's post hoc test for multiple comparisons, in the case of normal distribution of data between groups, while Kruskal-Wallis was used for comparison between groups where the distribution of data was different than normal. Values of p < 0.05 were considered to be statistically significant.
- Conditions
- Renal Disease, Dialysis; Complications, Anemia
- Being tested
- Alixir 400 Protect
- Keywords
- hemodialysis, anemia, oxidative stress, inflammation
- Medical subject headings
- Kidney Diseases, Anemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alixir 400 ProtectDietary supplement
During 30 days all patients take every day 30ml of Alixir 400 protect
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients on hemodialysis who consumed one month Standardized Aronia Melanocrpa extract Receives: Dietary Supplement: Alixir 400 Protect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia control
The iron levels Unit µmol/l
Measured: two months
Anemia control
The hemoglobin levels Unit g/l
Measured: two months
Anemia control
The ferritin levels Unit ng/ml
Measured: two months
Anemia control
The transferrin levels Unit g/l
Measured: two months
Secondary outcomes (3)
Oxidative stress
Superoxide anion radical, Hydrogen peroxide, Nitrites Units nmol/ml
Measured: two months
Oxidative stress
Superoxide dismutase, Catalase Units U/g Hb x 1000
Measured: two months
Oxidative stress
Reduced glutathione Unit nmol/l RBC x 1000
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Aug 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: All required data are already collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DiseaseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kragujevac
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmanova d.o.o., Obrenovac, Serbia
- Responsible party
- Principal investigator, Isidora Milosavljevic, University of Kragujevac
- Investigators
- Isidora Milosavljevic, Principal investigator, Department of pharmacy, University of Kragujevac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208451
- Sponsor's protocol ID
- Alixir400protect
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milosavljevic I, Jakovljevic V, Petrovic D, Draginic N, Jeremic J, Mitrovic M, Zivkovic V, Srejovic I, Stojic V, Bolevich S, Andjelkovic N. Standardized Aronia melanocarpa extract regulates redox status in patients receiving hemodialysis with anemia. Mol Cell Biochem. 2021 Nov;476(11):4167-4175. doi: 10.1007/s11010-021-04225-y. Epub 2021 Jul 29.
PubMed 34327604
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of One Month Consumption of Standardized Aronia Melanocarpa Extract on Anemia in Patients on Hemodialysis: Focus on Oxidative Stress and Inflammation
- ClinicalTrials.gov ID
- NCT04208451
- Acronym / sponsor ID
- Alixir400protect
- Conditions
- Renal Disease, Dialysis; Complications, Anemia
- Keywords
- hemodialysis, anemia, oxidative stress, inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All required data are already collected.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of KragujevacUniversity, hospital or other
- Collaborators
- Pharmanova d.o.o., Obrenovac, Serbia
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 23 Dec 2019 (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.
In this study are included patients on hemodialysis with anemia (levels of Hemoglobin<110). After baseline measurements tha patients take Standardized Aronia melanocarpa extract for one mont and then all measurements were repeated.
Detailed description
- Patients The study included 30 patients with chronic kidney failure on dialysis treatment at the Center for Nephrology and Dialysis of the Clinical Center Kragujevac. Inclusion criteria were: regular dialysis treatment for more than 3 months, 3 times a week and hemoglobin values lower than 110g / L. Exclusion criteria were: hemoglobin values lower than 80g/L, the use of antioxidant and immunosuppressive therapy, uncontrolled malignancies, proven active bleeding and presence of systemic inflammation or active infection.
- Ethical approval The research was conducted with respect to the Helsinki Declaration on Medical Research, the approval of the Ethics Committee of the Clinical Center Kragujevac No 01-14-3039. All subjects provided written informed consent before study enrollment.
- Used plant extract Standardized Aronia extract (SAE) is official product of pharmaceutical company Pharmanova (Belgrade, Serbia); nevertheless, procedure of extraction was done by EU-Chem company (Belgrade, Serbia). This product contains 400mg/30ml of polyphenols, while the recommended daily dosage is 30ml.
- Blood sampling Patients included in the study consumed standardized Aronia melanocarpa extract (30ml/day) for 30 days. On the day 0, before SAE consumption, blood samples from all patients were collected for hematologic analyzes, inflammation parameters, oxidative stress parameters and antioxidant protection before the dialysis procedure. All mentioned parameters were determined again after consuming the product, ie. on the 30th day of the study.
- Analytic Procedures Venous blood samples (2 x 4.5ml) were taken before the start of supplementation (zero day) and at the end of supplementation (30th day). Vacuum tubes with sodium citrate were used for blood sampling. The first sample was used for routine hematologic analyzes, the second sample was used for plasma and erythrocyte lysate extraction in order to determinate redox and inflammatory status.
- Evaluation of Systemic Redox State Plasma samples were used for determination of the levels of the following pro-oxidants: superoxide anion radical (O2-), hydrogen peroxide (H2O2), nitrites (NO2-) and index of lipid peroxidation measured as thiobarbituric acid reactive substances (TBARS), while the parameters of antioxidative defence system, such as activities of superoxide dismutase (SOD) and catalase (CAT) and level of reduced glutathione (GSH) were determined in erythrocytes lysates samples.
- Index of lipid peroxidation (TBARS) determination The degree of lipid peroxidation in the plasma samples was estimated by measuring TBARS, using 1% thiobarbituric acid in 0.05 NaOH, which was incubated with the sample at 100°C for 15 min and measured at 530 nm. TBA extract was obtained by combining 0.8 ml sample and 0.4 ml trichloro acetic acid (TCA); afterwards, the samples were put on ice for 10 min and centrifuged for 15 min at 6000 rpm. (1).
- Nitrite determination (NO2-) Nitric oxide (NO) decomposes rapidly to form stable nitrite/nitrate products. The NO2- level was measured and used as an index of NO production, using Griess's reagent. For NO2 - determination in plasma 0.1 ml 3 N PCA (perchloride acid), 0.4 ml 20 mM ethylenediaminetetraacetic acid (EDTA) and 0.2 ml plasma were put on ice for 15 min, then centrifuged for 15 min at 6000 rpm. After pouring off the supernatant, 220 μl K2CO3 was added. Nitrites were measured at 550 nm. (2)
- Superoxide anion radical determination (O2-) Superoxide anion radical concentrations in plasma samples were measured using the NTB (Nitro Blue Tetrazolium) reagent in TRIS buffer (assay mixture). The measurement was performed at a wavelength of 530 nm. (3).
- Hydrogen peroxide determination (H2O2) The measurement of H2O2 was based on the oxidation of phenol red by H2O2 in a reaction catalyzed by horseradish peroxidase. Two hundred microlitres of perfusate or plasma was precipitated using 800 mL of freshly prepared phenol red solution; 10 μL of (1:20) horseradish peroxidase (made immediately before use) was subsequently added. The level of H2O2 was measured at 610 nm (4).
- Determination of reduced glutathione (GSH) The level of reduced glutathione (GSH) was determined based on GSH oxidation via 5,5-dithiobis-6,2-nitrobenzoic acid. GSH extract was obtained by combining 0.1 ml 0.1% EDTA, 400 μl hemolysate, and 750 μl precipitation solution (containing 1.67 g metaphosphoric acid, 0.2 g EDTA, 30 g NaCl, and filled with distilled water until 100 ml; the solution is stable for 3 weeks at +4C°). The level of GSH was measured at 420 nm (5).
- Determination of antioxidant enzymes (SOD, CAT) Isolated RBCs were washed three times with three volumes of ice-cold 0.9 mmol/l NaCl, and hemolysates containing about 50 g Hb/l were used for the determination of CAT activity. CAT buffer, prepared hemolysate sample, and 10 mM H2O2 were used for CAT determination. Detection was performed at 360 nm. SOD activity was determined by the epinephrine method. Hemolysate was mixed with carbonate buffer, and then epinephrine was added. Detection was performed at 470 nm (6-10).
- Evaluation of the inflammatory status In order to evaluate the inflammatory status of patients, following parameters were measured at both points of interest (0 and 30th day): serum C-reactive protein concentration - CRP and tumor necrosis factor concentration - TNF-α. The serum C- reactive protein (CRP) concentration was determined by the turbidimetric method on the Olympus AU680. The normal serum CRP concentration is ≤ 5 mg/L. Microinflammation is defined as the concentration of CRP in the serum of 5 mg/L. Plasma TNF-α concentrations were determined by enzyme linked immunoadsorbent assay (ELISA) using commercially available high sensitivity indirect sandwich enzyme-linked immunosorbent assay (Sigma Aldrich).
- Evaluation of the hematological parameters At both points of interest, the values of the following haematological parameters in all patients were analyzed: Erythrocytes (Er), hemoglobin (Hb), hematocrit (Hct), erythrocyte index- mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), serum lactate dehydrogenase concentration (LDH), serum haptoglobin concentration and iron status: serum iron concentration, ferritin; total iron binding capacity (TIBC), unsaturated iron binding capacity (UIBC), transferrin saturation (TSAT), haptoglobin.
- Statistical Analysis IBM SPSS Statistics 20.0 Desktop for Windows was used for statistical analysis. Shapiro-Wilk test was used to check the distribution of data. Statistical comparisons were performed using the one-way analysis of variance (ANOVA) tests with a Tukey's post hoc test for multiple comparisons, in the case of normal distribution of data between groups, while Kruskal-Wallis was used for comparison between groups where the distribution of data was different than normal. Values of p < 0.05 were considered to be statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Alixir 400 ProtectPatients on hemodialysis who consumed one month Standardized Aronia Melanocrpa extract |
Who may qualify
- Ages
- 37 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- regular dialysis treatment for more than 3 months, 3 times a week
- hemoglobin values lower than 110g / L
Key exclusion criteria (5 listed)
- hemoglobin values lower than 80g/L,
- the use of antioxidant and immunosuppressive therapy,
- uncontrolled malignancies,
- proven active bleeding
- presence of systemic inflammation or active infection
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 |
|---|---|---|
| Alixir 400 ProtectDuring 30 days all patients take every day 30ml of Alixir 400 protect | Dietary supplement | Experimental group |
Primary outcome
Anemia control
Time frame: two months
The iron levels Unit µmol/l
Anemia control
Time frame: two months
The hemoglobin levels Unit g/l
Anemia control
Time frame: two months
The ferritin levels Unit ng/ml
Anemia control
Time frame: two months
The transferrin levels Unit g/l
3 secondary outcomes
Oxidative stress
Time frame: two months
Oxidative stress
Time frame: two months
Oxidative stress
Time frame: two months
Results and safety
The study was stopped early (reason given: All required data are already collected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Derived from this study: PubMed 34327604Milosavljevic I, Jakovljevic V, Petrovic D, Draginic N, Jeremic J, Mitrovic M, Zivkovic V, Srejovic I, Stojic V, Bolevich S, Andjelkovic N. Standardized Aronia melanocarpa extract regulates redox status in patients receiving hemodialysis with anemia. Mol Cell Biochem. 2021 Nov;476(11):4167-4175. doi: 10.1007/s11010-021-04225-y. Epub 2021 Jul 29.
- Individual participant dataSharing planned: No
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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.
Isidora Milosavljevic principal investigator
Department of pharmacy, University of Kragujevac
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alixir 400 Protect in people with Renal Disease and Dialysis; Complications, run by University of Kragujevac at 1 site in Serbia.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Dec 2019. 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 Serbia. 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 was stopped early (reason given: All required data are already collected.). Results are not available in the source record.
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?
Anemia control (time frame: two months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208451, which also lists 1 linked publication.
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 24 Dec 2019.