Effects of Cranberry Supplementation on Chronic Kidney Disease Patients.

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Renal Insufficiency, Chronic; Oxidative Stress; Gastrointestinal Microbiome
• Intervention / Treatment: Dietary supplement: Cranberry; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22260050
    • Denise Mafra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cranberry; Administration of 2 capsules with 500mg (Miralys Ltda) of cranberry extract per day, for 8 weeks	Dietary supplement: Cranberry; The patients will receive 2 capsules per day containing 500mg of cranberry extract for 8 weeks
Placebo Comparator: Placebo; Administration of 2 capsules with 500mg of maize starch per day, for 8 weeks	Dietary supplement: Placebo; The patients will receive 2 capsules per day containing 500mg of maize starch for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antioxidants and anti-inflammatory biomarkers	Evaluate the supplementation effects in anti-inflammatory biomarkers- Nrf2 and antioxidants enzymes	3 months
Inflammatory biomarkers	Evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha)	3 months
Biochemical Routine	Urea, creatinine, albumin, lipid profile plasma levels	12 weeks
Uremic toxins	P-cresol, indoxyl sulfate plasma levels	6 months

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Investigators: Principal Investigator: Denise Mafra, PhD, Universidade Federal Fluminense

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: May 3, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Inflammation; Renal Insufficiency
• Other Study ID Numbers: DeniseMafra6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No