Effects of Cranberry Supplementation on Chronic Kidney Disease Patients.
Condition: Renal Insufficiency, Chronic; Inflammation; Oxidative Stress; Gastrointestinal Microbiome
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Inflammation
Study type: Interventional

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.
    

Intervention name(s): Cranberry; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The patients will receive 2 capsules per day containing 500mg of cranberry extract for 8 weeks; The patients will receive 2 capsules per day containing 500mg of maize starch for 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care