Oxidative StressNCT02974491
Consumption of Apple Juice in Hemodialysis Patients
A study testing Fuji apple juice in people with Oxidative Stress, run by Universidade Federal de Santa Catarina.
Trial summary
The investigators hypothesized that acute consumption of Fuji apple juice (AJ) could increase the antioxidant status and/or decrease the oxidative stress (OS) biomarkers, without increasing serum biochemical parameters in patients undergoing maintenance hemodialysis (MHD). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Fuji apple juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Oct 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemodialysis treatment ≥ 3 months, age ≥ 20 years, and body mass index ≥ 23 kg/m2
Who cannot join
- allergy to apple, presence of cancer or acquired immunodeficiency syndrome, kidney transplant less than 6 months before enrolling in the study, taking antioxidant or nutritional supplements during the 30 days before enrollment, having been hospitalized within 6 weeks before the beginning of the study, or suffering from an acute illness
About this study
Official title: Acute Consumption of Fuji Apple Juice Does Not Affect Oxidative Stress Biomarkers in Hemodialysis Patients: A Pilot Intervention Study
The investigators hypothesized that acute consumption of Fuji apple juice (AJ) could increase the antioxidant status and/or decrease the oxidative stress (OS) biomarkers, without increasing serum biochemical parameters in patients undergoing maintenance hemodialysis (MHD). In this pre-post pilot feasibility study, patients served as their own controls, received 300 and 150 mL AJ immediately after a dialysis section, on different days, with a 3 week-washout period. Blood was collected at the baseline period, after 30 and 60 min of AJ consumption. OS biomarkers (total antioxidant status (TAS), total oxidant status (TOS), ascorbic acid, catalase (CAT), glutathione peroxidase (Gpx), superoxide dismutase (SOD) and reduced glutathione (GSH) and potassium, phosphorus, uric acid, and glucose concentrations were analyzed.
Read the detailed description
Subjects and study design
In this pre-post pilot feasibility study, subjects served as their own controls. Participants were recruited from a hemodialysis clinic, located in Florianópolis' metropolitan area, Santa Catarina state (Southern Brazil), from June to August 2015 with the following inclusion criteria: hemodialysis treatment ≥ 3 months, age ≥ 20 years, and body mass index (BMI) ≥ 23 kg/m2. Exclusion criteria were allergy to apple, presence of cancer or acquired immunodeficiency syndrome, kidney transplant less than 6 months before enrolling in the study, taking antioxidant or nutritional supplements during the 30 days before enrollment, having been hospitalized within 6 weeks before the beginning of the study, or suffering from an acute illness.
Subjects were instructed to keep their usual dietary habits for the duration of the study, except for avoiding intake of polyphenol-rich foods (i.e., vegetables, fruits and fruit-containing products, chocolate, tea, coffee, honey, and any alcoholic beverage) within 2 days before and during intervention. On two different days, each volunteer consumed 300 mL Fuji AJ, immediately after a dialysis section. After a washout period of 3 weeks, the volunteers drank 150 mL Fuji AJ in a similar manner as described above. Before and after 30 and 60 min of AJ consumption, blood samples were withdrawn for biochemical analysis. This protocol was chosen taking into account the previous favorable effects of AJ consumption on serum OS biomarkers described for healthy volunteers.
Baseline clinical and biochemical data were obtained from medical records. This study was approved by the ethics committee of human research of the Federal University of Santa Catarina (UFSC) (protocol number 37090614.6.0000.0118) and all participants gave written and informed consent.
Apple juice and analysis
Fuji apples were obtained from the Experimental Seasonal Fields at the Empresa de Pesquisa Agropecuária e Extensão Rural de Santa Catarina' Station in the city of São Joaquin, Santa Catarina, Brazil (latitude 28º 17' 39", longitude 49º 55' 56" and altitude 1.415 m), harvested in their commercial maturation stage during 2015's harvest. After harvest, apples were stored at 4 ± 1°C. To allow for a quick and easy apple intake in large amounts, 300 mL of AJ, equivalent to 3.5 apples, and 150 mL AJ, equivalent to 1.5 apples were used. Before preparing the juice, the fruits were sanitized in sodium hypochlorite. Apples with peel and no seeds were blended in a centrifugal juice extractor without water addition. Each dose of AJ was prepared and consumed immediately.
The contents of dry matter, total soluble solids, potential of hydrogen (pH) and titratable acidity of AJ were measured following official methods. The total phenolic content of the AJ extracts was measured using the Folin-Ciocalteu method colorimetric. The total flavanol content was estimated using p-dimethylaminocinnamaldehyde (DMACA) method. The total antioxidant capacity was determined using the DPPH (2,2-diphenyl-1-picryl-hydrazyl-hydrate) method. For total monomeric anthocyanin, a spectrophotometric pH differential method was used. Analyses were conducted with each AJ used in the two intervention days, in triplicate.
Blood sampling and laboratory methods
In each experiment day, blood samples from participants were collected in three different moments. Venous blood samples were collected using a vacuum system (Vacutainer Becton Dickinson BD®, São Paulo, Brazil) into heparin, Ethylenediaminetetraacetic acid (EDTA)-containing tubes or additive-free tubes. Plasma and serum were immediately obtained by centrifugation (3,000 revolutions per minute (RPM), 10 min, room temperature) for the measurement of uric acid, phosphorus, glucose, potassium, Total Antioxidant Status (TAS) and Total Oxidant Status( TOS). In order to quantify the endogenous antioxidant enzymes, an aliquot of whole blood was lysed. In order to measure reduced glutathione (GSH), an aliquot of whole blood was preserved in N-ethylmaleimide (NEM). All samples were immediately stored at -80°C for later analysis in duplicate.
Serum uric acid, phosphorus and glucose concentrations were determined using commercially available kits (Labtest Diagnóstica SA, Lagoa Santa, Minas Gerais, Brazil) in an automated multi-biochemical analyzer (Cobas Miras Plus, Roche®, Germany). Serum potassium levels were measured in an automated Dimension Max System (Siemens Healthcare Diagnostics Products®, Germany), according to the manufacturer's instructions.
TAS and TOS assays were measured spectrophotometrically, according to Erel's methods. Ascorbic acid and GSH were determined using high-performance liquid chromatography (HPLC), as previously described. The superoxide dismutase (SOD) activity was evaluated using SOD Assay Kit (Sigma Aldrich®, St. Louis, Missouri, USA) according to the manufacturer's instructions. Catalase (CAT) activity was determined spectrophotometrically according to the previously described method. The glutathione peroxidase (GPx) activity was determined using the NADPH oxidation rate method.
- Conditions
- Oxidative Stress
- Being tested
- Fuji apple juice
- Keywords
- hemodialysis, diabetes mellitus, apple juice, potassium
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuji apple juiceOther
On two different days, each volunteer consumed 300 mL Fuji apple juice (AJ), immediately after a dialysis section. After a washout period of 3 weeks, the volunteers drank 150 mL Fuji AJ in a similar manner as described above. Before and after 30 and 60 min of AJ consumption, blood samples were withdrawn for biochemical analysis.
| Study group | Role | What they receive |
|---|---|---|
| Apple Juice | Experimental | Not described Receives: Other: Fuji apple juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring oxidative stress biomarkers
Total antioxidant status (TAS) (mmol/L) and total oxidant status (TOS) (mmol/L) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measured: Change from baseline at 30 and 60 minutes
Measuring endogenous antioxidant enzymes
Catalase (U mg/Hb), glutathione peroxidase (U mg/Hb) and superoxide dismutase (U mg/Hb) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measured: Change from baseline at 30 and 60 minutes
Measuring oxidative stress biomarkers
Ascorbic acid (micromole/L) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measured: Change from baseline at 30 and 60 minutes
Measuring oxidative stress biomarkers
Reduced glutathione (micromole mg/Hb) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measured: Change from baseline at 30 and 60 minutes
Measuring serum biochemical parameters
Potassium (mmol/L), phosphorus (mmol/L) and glucose (mmol/L) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measured: Change from baseline at 30 and 60 minutes
Measuring serum biochemical parameters
Uric acid (micromole/L) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measured: Change from baseline at 30 and 60 minutes
Evaluating heigth
Height (meters) data were obtained from the patient's files.
Measured: at baseline
Evaluating weight
Weight (kilograms) data were obtained from the patient's files.
Measured: At baseline
Evaluating body mass index
Body mass index (BMI) (Kg/m2) data were obtained from the patient's files.
Measured: At baseline
Evaluating medication
Medication data were obtained from the patient's files.
Measured: At baseline
Evaluating adequacy of the dialysis treatment
Adequacy of the dialysis treatment was captured by extracting the routine Kt/V from the medical record.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréia G. Giaretta, Universidade Federal de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974491
- Sponsor's protocol ID
- 37090614.6.0000.0118
- Status last verified
- Nov 2016
- First submitted
- 10 Nov 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruskovska T, Jansen EH, Antarorov R. Evaluation of assays for measurement of serum (anti)oxidants in hemodialysis patients. Biomed Res Int. 2014;2014:843157. doi: 10.1155/2014/843157. Epub 2014 May 19.
PubMed 24982909Halliwell, B, Gutteridge, JMC. Cellular responses to oxidative stress: adaptation, damage, repair, senescence and death. In: Halliwell, B, Gutteridge, JMC. Free Radical in Biology and Medicine. 4th ed. Oxford, UK: Oxford University Press; 2007, p. 87-267.
McDonald CI, Fraser JF, Coombes JS, Fung YL. Oxidative stress during extracorporeal circulation. Eur J Cardiothorac Surg. 2014 Dec;46(6):937-43. doi: 10.1093/ejcts/ezt637. Epub 2014 Jan 30.
PubMed 24482384Melidou M, Riganakos K, Galaris D. Protection against nuclear DNA damage offered by flavonoids in cells exposed to hydrogen peroxide: the role of iron chelation. Free Radic Biol Med. 2005 Dec 15;39(12):1591-600. doi: 10.1016/j.freeradbiomed.2005.08.009. Epub 2005 Aug 29.
PubMed 16298684Spormann TM, Albert FW, Rath T, Dietrich H, Will F, Stockis JP, Eisenbrand G, Janzowski C. Anthocyanin/polyphenolic-rich fruit juice reduces oxidative cell damage in an intervention study with patients on hemodialysis. Cancer Epidemiol Biomarkers Prev. 2008 Dec;17(12):3372-80. doi: 10.1158/1055-9965.EPI-08-0364.
PubMed 19064553Castilla P, Echarri R, Davalos A, Cerrato F, Ortega H, Teruel JL, Lucas MF, Gomez-Coronado D, Ortuno J, Lasuncion MA. Concentrated red grape juice exerts antioxidant, hypolipidemic, and antiinflammatory effects in both hemodialysis patients and healthy subjects. Am J Clin Nutr. 2006 Jul;84(1):252-62. doi: 10.1093/ajcn/84.1.252.
PubMed 16825703Shema-Didi L, Sela S, Ore L, Shapiro G, Geron R, Moshe G, Kristal B. One year of pomegranate juice intake decreases oxidative stress, inflammation, and incidence of infections in hemodialysis patients: a randomized placebo-controlled trial. Free Radic Biol Med. 2012 Jul 15;53(2):297-304. doi: 10.1016/j.freeradbiomed.2012.05.013. Epub 2012 May 17.
PubMed 22609423Fouque D, Kalantar-Zadeh K, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H, Guarnieri G, Ikizler TA, Kaysen G, Lindholm B, Massy Z, Mitch W, Pineda E, Stenvinkel P, Trevino-Becerra A, Wanner C. A proposed nomenclature and diagnostic criteria for protein-energy wasting in acute and chronic kidney disease. Kidney Int. 2008 Feb;73(4):391-8. doi: 10.1038/sj.ki.5002585. Epub 2007 Dec 19.
PubMed 18094682Golding JB, McGlasson WB, Wyllie SG, Leach DN. Fate of apple peel phenolics during cool storage. J Agric Food Chem. 2001 May;49(5):2283-9. doi: 10.1021/jf0015266.
PubMed 11368590Dai X, Luo H, Jiang L, Ling L, Xue Y, Yu Z. Efficacy of different sanitizing agents and their combination on microbe population and quality of fresh-cut Chinese chives. J Food Sci. 2012 Jul;77(7):M348-53. doi: 10.1111/j.1750-3841.2012.02770.x. Epub 2012 Jun 18.
PubMed 22708729Association of Official Analytical Chemists (AOAC). Official Methods of Analysis. 18th ed. Washington, DC: Association of Official Analytical Chemists; 2005.
Singleton, VL, Rossi, JA. Colorimetry of total phenolics with phosphomolybdic phosphotungstic acid reagents. Am J Enol Vitic 1965;16(3):144-58.
Arnous, A, Markis, D, Kefalas, P. Correlation of pigment and flavonol content with antioxidant properties in selected aged regional wines from Greece. J Food Composit Ana 2002;15(6):655-65.
Brand-Williams, W, Cuvelier, ME, Berset, C. Use of free radical method to evaluate antioxidant activity. LWT Food Sci Technol 1995;28(1):25-30.
Giusti, MM, Wrolstad, RE. Anthocyanins: characterization and measurement with UV-visible spectroscopy. In: Wrolstald, RE, ed. Current Protocols in Food Analytical Chemistry. New York, NY: John Wiley and Sons; 2001, p. 1-13.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Consumption of Fuji Apple Juice Does Not Affect Oxidative Stress Biomarkers in Hemodialysis Patients: A Pilot Intervention Study
- ClinicalTrials.gov ID
- NCT02974491
- Acronym / sponsor ID
- 37090614.6.0000.0118
- Conditions
- Oxidative Stress
- Keywords
- hemodialysis, diabetes mellitus, apple juice, potassium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Nov 2016 (estimated)
- 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 investigators hypothesized that acute consumption of Fuji apple juice (AJ) could increase the antioxidant status and/or decrease the oxidative stress (OS) biomarkers, without increasing serum biochemical parameters in patients undergoing maintenance hemodialysis (MHD). In this pre-post pilot feasibility study, patients served as their own controls, received 300 and 150 mL AJ immediately after a dialysis section, on different days, with a 3 week-washout period. Blood was collected at the baseline period, after 30 and 60 min of AJ consumption. OS biomarkers (total antioxidant status (TAS), total oxidant status (TOS), ascorbic acid, catalase (CAT), glutathione peroxidase (Gpx), superoxide dismutase (SOD) and reduced glutathione (GSH) and potassium, phosphorus, uric acid, and glucose concentrations were analyzed.
Detailed description
Subjects and study design
In this pre-post pilot feasibility study, subjects served as their own controls. Participants were recruited from a hemodialysis clinic, located in Florianópolis' metropolitan area, Santa Catarina state (Southern Brazil), from June to August 2015 with the following inclusion criteria: hemodialysis treatment ≥ 3 months, age ≥ 20 years, and body mass index (BMI) ≥ 23 kg/m2. Exclusion criteria were allergy to apple, presence of cancer or acquired immunodeficiency syndrome, kidney transplant less than 6 months before enrolling in the study, taking antioxidant or nutritional supplements during the 30 days before enrollment, having been hospitalized within 6 weeks before the beginning of the study, or suffering from an acute illness.
Subjects were instructed to keep their usual dietary habits for the duration of the study, except for avoiding intake of polyphenol-rich foods (i.e., vegetables, fruits and fruit-containing products, chocolate, tea, coffee, honey, and any alcoholic beverage) within 2 days before and during intervention. On two different days, each volunteer consumed 300 mL Fuji AJ, immediately after a dialysis section. After a washout period of 3 weeks, the volunteers drank 150 mL Fuji AJ in a similar manner as described above. Before and after 30 and 60 min of AJ consumption, blood samples were withdrawn for biochemical analysis. This protocol was chosen taking into account the previous favorable effects of AJ consumption on serum OS biomarkers described for healthy volunteers.
Baseline clinical and biochemical data were obtained from medical records. This study was approved by the ethics committee of human research of the Federal University of Santa Catarina (UFSC) (protocol number 37090614.6.0000.0118) and all participants gave written and informed consent.
Apple juice and analysis
Fuji apples were obtained from the Experimental Seasonal Fields at the Empresa de Pesquisa Agropecuária e Extensão Rural de Santa Catarina' Station in the city of São Joaquin, Santa Catarina, Brazil (latitude 28º 17' 39", longitude 49º 55' 56" and altitude 1.415 m), harvested in their commercial maturation stage during 2015's harvest. After harvest, apples were stored at 4 ± 1°C. To allow for a quick and easy apple intake in large amounts, 300 mL of AJ, equivalent to 3.5 apples, and 150 mL AJ, equivalent to 1.5 apples were used. Before preparing the juice, the fruits were sanitized in sodium hypochlorite. Apples with peel and no seeds were blended in a centrifugal juice extractor without water addition. Each dose of AJ was prepared and consumed immediately.
The contents of dry matter, total soluble solids, potential of hydrogen (pH) and titratable acidity of AJ were measured following official methods. The total phenolic content of the AJ extracts was measured using the Folin-Ciocalteu method colorimetric. The total flavanol content was estimated using p-dimethylaminocinnamaldehyde (DMACA) method. The total antioxidant capacity was determined using the DPPH (2,2-diphenyl-1-picryl-hydrazyl-hydrate) method. For total monomeric anthocyanin, a spectrophotometric pH differential method was used. Analyses were conducted with each AJ used in the two intervention days, in triplicate.
Blood sampling and laboratory methods
In each experiment day, blood samples from participants were collected in three different moments. Venous blood samples were collected using a vacuum system (Vacutainer Becton Dickinson BD®, São Paulo, Brazil) into heparin, Ethylenediaminetetraacetic acid (EDTA)-containing tubes or additive-free tubes. Plasma and serum were immediately obtained by centrifugation (3,000 revolutions per minute (RPM), 10 min, room temperature) for the measurement of uric acid, phosphorus, glucose, potassium, Total Antioxidant Status (TAS) and Total Oxidant Status( TOS). In order to quantify the endogenous antioxidant enzymes, an aliquot of whole blood was lysed. In order to measure reduced glutathione (GSH), an aliquot of whole blood was preserved in N-ethylmaleimide (NEM). All samples were immediately stored at -80°C for later analysis in duplicate.
Serum uric acid, phosphorus and glucose concentrations were determined using commercially available kits (Labtest Diagnóstica SA, Lagoa Santa, Minas Gerais, Brazil) in an automated multi-biochemical analyzer (Cobas Miras Plus, Roche®, Germany). Serum potassium levels were measured in an automated Dimension Max System (Siemens Healthcare Diagnostics Products®, Germany), according to the manufacturer's instructions.
TAS and TOS assays were measured spectrophotometrically, according to Erel's methods. Ascorbic acid and GSH were determined using high-performance liquid chromatography (HPLC), as previously described. The superoxide dismutase (SOD) activity was evaluated using SOD Assay Kit (Sigma Aldrich®, St. Louis, Missouri, USA) according to the manufacturer's instructions. Catalase (CAT) activity was determined spectrophotometrically according to the previously described method. The glutathione peroxidase (GPx) activity was determined using the NADPH oxidation rate method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apple Juice | Experimental | Other: Fuji apple juice |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hemodialysis treatment ≥ 3 months, age ≥ 20 years, and body mass index ≥ 23 kg/m2
Key exclusion criteria (1 listed)
- allergy to apple, presence of cancer or acquired immunodeficiency syndrome, kidney transplant less than 6 months before enrolling in the study, taking antioxidant or nutritional supplements during the 30 days before enrollment, having been hospitalized within 6 weeks before the beginning of the study, or suffering from an acute illness
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 |
|---|---|---|
| Fuji apple juiceOn two different days, each volunteer consumed 300 mL Fuji apple juice (AJ), immediately after a dialysis section. After a washout period of 3 weeks, the volunteers drank 150 mL Fuji AJ in a similar manner as described above. Before and after 30 and 60 min of AJ consumption, blood samples were withdrawn for biochemical analysis. | Other | Apple Juice |
Primary outcome
Measuring oxidative stress biomarkers
Time frame: Change from baseline at 30 and 60 minutes
Total antioxidant status (TAS) (mmol/L) and total oxidant status (TOS) (mmol/L) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measuring endogenous antioxidant enzymes
Time frame: Change from baseline at 30 and 60 minutes
Catalase (U mg/Hb), glutathione peroxidase (U mg/Hb) and superoxide dismutase (U mg/Hb) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measuring oxidative stress biomarkers
Time frame: Change from baseline at 30 and 60 minutes
Ascorbic acid (micromole/L) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measuring oxidative stress biomarkers
Time frame: Change from baseline at 30 and 60 minutes
Reduced glutathione (micromole mg/Hb) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measuring serum biochemical parameters
Time frame: Change from baseline at 30 and 60 minutes
Potassium (mmol/L), phosphorus (mmol/L) and glucose (mmol/L) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Measuring serum biochemical parameters
Time frame: Change from baseline at 30 and 60 minutes
Uric acid (micromole/L) was measured at the baseline period, after 30 and 60 min of acute consumption of 300 and 150 mL of Fuji apple (Malus domestica Borkh) juice. Patients were not fasted for the withdrawal of blood. This measure was taken to prevent discomfort among volunteers. Venous blood samples were collected through aseptic venipuncture on the opposite arm of the arteriovenous fistula by a qualified professional using a vacuum system into heparin or EDTA-containing tubes or tubes without additives according to established standards of clinical and biological safety.
Evaluating heigth
Time frame: at baseline
Height (meters) data were obtained from the patient's files.
Evaluating weight
Time frame: At baseline
Weight (kilograms) data were obtained from the patient's files.
Evaluating body mass index
Time frame: At baseline
Body mass index (BMI) (Kg/m2) data were obtained from the patient's files.
Evaluating medication
Time frame: At baseline
Medication data were obtained from the patient's files.
Evaluating adequacy of the dialysis treatment
Time frame: At baseline
Adequacy of the dialysis treatment was captured by extracting the routine Kt/V from the medical record.
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 28 Nov 2016.
- Background: PubMed 24982909Ruskovska T, Jansen EH, Antarorov R. Evaluation of assays for measurement of serum (anti)oxidants in hemodialysis patients. Biomed Res Int. 2014;2014:843157. doi: 10.1155/2014/843157. Epub 2014 May 19.
- BackgroundHalliwell, B, Gutteridge, JMC. Cellular responses to oxidative stress: adaptation, damage, repair, senescence and death. In: Halliwell, B, Gutteridge, JMC. Free Radical in Biology and Medicine. 4th ed. Oxford, UK: Oxford University Press; 2007, p. 87-267.
- Background: PubMed 24482384McDonald CI, Fraser JF, Coombes JS, Fung YL. Oxidative stress during extracorporeal circulation. Eur J Cardiothorac Surg. 2014 Dec;46(6):937-43. doi: 10.1093/ejcts/ezt637. Epub 2014 Jan 30.
- Background: PubMed 16298684Melidou M, Riganakos K, Galaris D. Protection against nuclear DNA damage offered by flavonoids in cells exposed to hydrogen peroxide: the role of iron chelation. Free Radic Biol Med. 2005 Dec 15;39(12):1591-600. doi: 10.1016/j.freeradbiomed.2005.08.009. Epub 2005 Aug 29.
- Background: PubMed 19064553Spormann TM, Albert FW, Rath T, Dietrich H, Will F, Stockis JP, Eisenbrand G, Janzowski C. Anthocyanin/polyphenolic-rich fruit juice reduces oxidative cell damage in an intervention study with patients on hemodialysis. Cancer Epidemiol Biomarkers Prev. 2008 Dec;17(12):3372-80. doi: 10.1158/1055-9965.EPI-08-0364.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fuji apple juice in people with Oxidative Stress, run by Universidade Federal de Santa Catarina.
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 1 inclusion and 1 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Measuring oxidative stress biomarkers (time frame: Change from baseline at 30 and 60 minutes). The study lists 11 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 NCT02974491, which also lists 23 linked publications.
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 28 Nov 2016.