Effects of Cranberry Supplementation on Chronic Kidney Disease Patients.
Primary Purpose
Renal Insufficiency, Chronic, Inflammation, Oxidative Stress
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cranberry
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Insufficiency, Chronic
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Chronic Kidney Disease in conservative treatment
- Aged 18 years or older
- Must be able to swallow tablets
Exclusion Criteria:
- Patients pregnant
- Smokers
- Using antibiotics in the last 3 months
- Using antioxidant supplements in the last 3 months
- Usual intake of cranberry fruit or extract
- Clinical diagnosis of infectious diseases
- Clinical diagnosis of Cancer
- Clinical diagnosis of AIDS
Sites / Locations
- Denise Mafra
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cranberry
Placebo
Arm Description
Administration of 2 capsules with 500mg (Miralys Ltda) of cranberry extract per day, for 8 weeks
Administration of 2 capsules with 500mg of maize starch per day, for 8 weeks
Outcomes
Primary Outcome Measures
Antioxidants and anti-inflammatory biomarkers
Evaluate the supplementation effects in anti-inflammatory biomarkers- Nrf2 and antioxidants enzymes
Inflammatory biomarkers
Evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha)
Biochemical Routine
Urea, creatinine, albumin, lipid profile plasma levels
Uremic toxins
P-cresol, indoxyl sulfate plasma levels
Secondary Outcome Measures
Full Information
NCT ID
NCT04377919
First Posted
September 28, 2018
Last Updated
January 4, 2022
Sponsor
Universidade Federal Fluminense
1. Study Identification
Unique Protocol Identification Number
NCT04377919
Brief Title
Effects of Cranberry Supplementation on Chronic Kidney Disease Patients.
Official Title
Effects of Cranberry Supplementation on Chronic Kidney Disease Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Federal Fluminense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with chronic kidney disease (CKD) have several complications that are linked to oxidative stress and inflammation, and among the most recently studied is the alteration of the intestinal microbiota. Considering this scenario, bioactive compounds have been considered as a therapeutic alternative in the modulation of intestinal microbiota as well as transcription factors such as nuclear-kappa factor B (NF-κB) and factor 2 nuclear factor-related erythroid 2 Nrf2), involved with oxidative stress and inflammation. Among several foods, cranberry is a fruit rich in flavonoids and other polyphenols, which has antioxidant, anti-inflammatory and immunoregulatory actions and may be an adjuvant treatment for CKD complications. However, clinical evidence evaluating the effects of cranberry is limited and there are no studies specifically involving patients with CKD. Thus, the present randomized crossover double-blind crossover with placebo-controlled washout period will aim to evaluate the effects of cranberry supplementation on the modulation of the intestinal microbiota and expression of transcription factors as well as cytokine levels inflammatory effects of CKD patients.
Detailed Description
This is a longitudinal study with a randomized crossover design, double-blind, placebo-controlled, and with washout period. Thirty non-dialysis patients of both genders, aged between 18 and 60 years and with CKD stage3-4 (glomerular filtration rate < 59 mL/min/1.73 m2) will be included in the study. Pregnant patients, smokers and those under use of antibiotics in the last 3 months, or in use antithrombotic, pre-, pro- or synbiotic supplements, antioxidant supplements or habitual cranberry intake will be excluded. In addition, those with autoimmune and infectious diseases, cancer, liver diseases and HIV will also not be included in the study. The patients that fulfill the eligible criteria and sign the ethical informed consent will be randomized to either Group A (Cranberry) or Group B (Placebo). During 12 weeks, patients allocated in group A will receive capsules containing cranberry extract (Vaccinium macrocarpon to 25% anthocyanosides 160mg, equivalent to 40mg anthocyanosides), once daily (lunch), totaling 500mg / day and those allocated in the group B will receive a placebo (500mg of corn starch). After the supplementation period, a 12-week washout will be performed for subsequent crossover of the supplement. The randomization will be computed in the ratio of 1: 1, with block size of 15 (Cranberry group and Control), to receive cranberry or placebo. This project was approved by the Ethics Committee of the Faculty of Medicine-UFF, n. 2.653.752.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Inflammation, Oxidative Stress, Gastrointestinal Microbiome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cranberry
Arm Type
Active Comparator
Arm Description
Administration of 2 capsules with 500mg (Miralys Ltda) of cranberry extract per day, for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administration of 2 capsules with 500mg of maize starch per day, for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry
Intervention Description
The patients will receive 2 capsules per day containing 500mg of cranberry extract for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The patients will receive 2 capsules per day containing 500mg of maize starch for 8 weeks
Primary Outcome Measure Information:
Title
Antioxidants and anti-inflammatory biomarkers
Description
Evaluate the supplementation effects in anti-inflammatory biomarkers- Nrf2 and antioxidants enzymes
Time Frame
3 months
Title
Inflammatory biomarkers
Description
Evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha)
Time Frame
3 months
Title
Biochemical Routine
Description
Urea, creatinine, albumin, lipid profile plasma levels
Time Frame
12 weeks
Title
Uremic toxins
Description
P-cresol, indoxyl sulfate plasma levels
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Chronic Kidney Disease in conservative treatment
Aged 18 years or older
Must be able to swallow tablets
Exclusion Criteria:
Patients pregnant
Smokers
Using antibiotics in the last 3 months
Using antioxidant supplements in the last 3 months
Usual intake of cranberry fruit or extract
Clinical diagnosis of infectious diseases
Clinical diagnosis of Cancer
Clinical diagnosis of AIDS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Mafra, phd
Organizational Affiliation
Universidade Federal Fluminense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
ZIP/Postal Code
22260050
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Cranberry Supplementation on Chronic Kidney Disease Patients.
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