Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

Effects of Cranberry Supplementation on Chronic Kidney Disease 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. Identifier: NCT04377919
Recruitment Status : Completed
First Posted : May 7, 2020
Last Update Posted : January 5, 2022
Information provided by (Responsible Party):
Universidade Federal Fluminense

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Inflammation Oxidative Stress Gastrointestinal Microbiome Dietary Supplement: Cranberry Dietary Supplement: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Cranberry Supplementation on Chronic Kidney Disease Patients.
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : December 1, 2021
Actual Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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

Primary Outcome Measures :
  1. Antioxidants and anti-inflammatory biomarkers [ Time Frame: 3 months ]
    Evaluate the supplementation effects in anti-inflammatory biomarkers- Nrf2 and antioxidants enzymes

  2. Inflammatory biomarkers [ Time Frame: 3 months ]
    Evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha)

  3. Biochemical Routine [ Time Frame: 12 weeks ]
    Urea, creatinine, albumin, lipid profile plasma levels

  4. Uremic toxins [ Time Frame: 6 months ]
    P-cresol, indoxyl sulfate plasma levels

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:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04377919

Layout table for location information
Denise Mafra
Rio de Janeiro, Brazil, 22260050
Sponsors and Collaborators
Universidade Federal Fluminense
Layout table for investigator information
Principal Investigator: Denise Mafra, phd Universidade Federal Fluminense
Layout table for additonal information
Responsible Party: Universidade Federal Fluminense Identifier: NCT04377919    
Other Study ID Numbers: DeniseMafra6
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Pathologic Processes
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Chronic Disease
Disease Attributes