Effects of Cranberry Supplementation on Chronic Kidney Disease Patients.

• ClinicalTrials.gov Identifier: NCT04377919
• Recruitment Status: Completed
• First Posted: May 7, 2020
• Last Update Posted: January 5, 2022
• Sponsor: Universidade Federal Fluminense
• Information provided by (Responsible Party): Universidade Federal Fluminense

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

Brazil

Denise Mafra

Rio de Janeiro, Brazil, 22260050

Sponsors and Collaborators

Universidade Federal Fluminense

Investigators

• Principal Investigator: Denise Mafra, phd; Universidade Federal Fluminense

More Information

• Responsible Party: Universidade Federal Fluminense
• ClinicalTrials.gov Identifier: NCT04377919
• Other Study ID Numbers: DeniseMafra6
• First Posted: May 7, 2020
• Last Update Posted: January 5, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Inflammation; Pathologic Processes; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes