Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Consumption of Apple Juice in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02974491
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Andréia G. Giaretta, Universidade Federal de Santa Catarina

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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). 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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Other: Fuji apple juice Not Applicable

  Show Detailed Description

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Consumption of Fuji Apple Juice Does Not Affect Oxidative Stress Biomarkers in Hemodialysis Patients: A Pilot Intervention Study
Study Start Date : August 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Apple Juice Other: Fuji apple juice
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Evaluating heigth [ Time Frame: at baseline ]
    Height (meters) data were obtained from the patient's files.

  8. Evaluating weight [ Time Frame: At baseline ]
    Weight (kilograms) data were obtained from the patient's files.

  9. Evaluating body mass index [ Time Frame: At baseline ]
    Body mass index (BMI) (Kg/m2) data were obtained from the patient's files.

  10. Evaluating medication [ Time Frame: At baseline ]
    Medication data were obtained from the patient's files.

  11. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hemodialysis treatment ≥ 3 months, age ≥ 20 years, and body mass index ≥ 23 kg/m2

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Halliwell, 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.
Association 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.
International Diabetes Federation. Guideline for management of postmeal glucose in diabetes, http://www.idf.org/sites/default/files/postmeal%20glucose%20guidelines.pdf; 2011 [accessed 03.10.16].

Layout table for additonal information
Responsible Party: Andréia G. Giaretta, principal investigator, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier: NCT02974491     History of Changes
Other Study ID Numbers: 37090614.6.0000.0118
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Keywords provided by Andréia G. Giaretta, Universidade Federal de Santa Catarina:
hemodialysis
diabetes mellitus
apple juice
potassium