NCT04377919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2018

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

3.3 years

First QC Date

September 28, 2018

Last Update Submit

January 4, 2022

Conditions

Renal Insufficiency, ChronicInflammationOxidative StressGastrointestinal Microbiome

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Cranberry

ACTIVE COMPARATOR

Administration of 2 capsules with 500mg (Miralys Ltda) of cranberry extract per day, for 8 weeks

Dietary Supplement: Cranberry

Placebo

PLACEBO COMPARATOR

Administration of 2 capsules with 500mg of maize starch per day, for 8 weeks

Dietary Supplement: Placebo

Interventions

CranberryDIETARY_SUPPLEMENT

The patients will receive 2 capsules per day containing 500mg of cranberry extract for 8 weeks

Cranberry
PlaceboDIETARY_SUPPLEMENT

The patients will receive 2 capsules per day containing 500mg of maize starch for 8 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Chronic Kidney Disease in conservative treatment
  • Aged 18 years or older
  • Must be able to swallow tablets

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denise Mafra

Rio de Janeiro, 22260050, Brazil

Location

Related Publications (1)

  • de Souza Gouveia Moreira L, Resende Teixeira KT, Cardozo LFMF, Alvarenga L, Regis B, Sousa de Brito J, de Oliveira Leal V, Borges NA, de Souza da Costa Brum I, Carraro-Eduardo JC, Borini GB, Berretta AA, Ribeiro-Alves M, Mafra D. Effects of Cranberry Extract (Vaccinium macrocarpon) Supplementation on Lipid Peroxidation and Inflammation in Patients with Chronic Kidney Disease (Stages 3-4): A Randomized Controlled Trial. J Nutr Metab. 2024 May 8;2024:9590066. doi: 10.1155/2024/9590066. eCollection 2024.

    PMID: 38752013DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicInflammation

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Denise Mafra, phd

    Universidade Federal Fluminense

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2018

First Posted

May 7, 2020

Study Start

August 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 5, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)