Effect of Broccoli Sprout Extract in Patients With Chronic Kidney Disease With Diabetes Type 2
Condition: Chronic Kidney Disease Stage 3B; Chronic Kidney Disease stage4; Diabetes Mellitus, Type 2
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This research project aims to test if sulforaphane, administered as broccoli sprout extract
      (BSE) can ameliorate glucose control in adult patients with chronic kidney disease (CKD) and
      DM 2 with GFR > 15 < 45 ml/min/1.73 m2. The glucose control will be evaluated by the oral
      glucose tolerance test. Moreover, as a secondary aim, we will investigate the role of
      sulforaphane in improving other signs of metabolic derangements present in this group of
      patients, including oxidate stress, proteinuria, inflammation and a decrease in the
      production of uremic toxins from the gut microbiota. This a multicentre randomized
      double-blinded controlled trial including 100 adult patients with CKD and glomerular
      filtration rate (GFR) between 15 and 29 ml/min/1.73m2, DM type 2, age > 18 years old.
      Patients will be randomized into BSE group or Placebo group. Both groups will be followed for
      20 weeks: The first 12 weeks patients will receive the BSE or Placebo and, the next 8 weeks,
      both groups will be followed with no intervention to observe the changes in the primary and
      secondary outcomes. Patients randomized to BSE Group will receive 50 µmmol/day of
      sulforaphane administered as BSE (Lantmännen®) from week 0 to week 4. If no side-effects are
      reported, the sulforaphane dose will increase to 100 µmmol/day from week 5 to week 8 and in
      the absence of side-effects, the dose will increase to 150 µmmol/day from week 9 to week 12.
      Blood and urine samples and OGTT (in non-insulin dependent patients) will be performed at
      week 0, 12 and 20. On week 4 and 8 blood drawn for partial exam will be performed. The BSE
      and the placebo (maltodextrin sprayed with copper-chlorophyllin) will be administered as
      powder provided in a double-blind manner as dry mixtures in sealed portion size bags of
      similar shape and size. Randomization will be done using a computer-based block randomization
      algorithm. Comparisons between the primary and secondary studied variables will be done with
      two-way analysis of variance (ANOVA) with repeated measures for normally distributed
      variables. Variables that can interfere with the glycemic control, such as changes in the
      dosage of hypoglicemiants agents and insulin during the intervention will be controlled in
      the analysis. Those non-normally distributed will be log transformed aiming to normalize the
      distribution. All test will consider a P<0.05 for statistical significance. The software
      Stata will be used for the statistical analysis.
    


Intervention name(s): Sulforaphane, administered as Broccoli sprout extract
Intervention type(s): Other
Intervention description(s): Patients will randomized to BSE or Control Group. The group BSE will receive the sulforaphane, administered as broccoli sprout extract for 12 weeks. The dose will increase every four weeks if no side-effects are reported (50 µmmol/day; 100 µmmol/day and 150 µmmol/day, respectivelly). The Control group will receive a placebo (maltodextrin sprayed with copper-chlorophyllin) for the same period (12 weeks). The BSE/placebo will be administered as powder provided in 10 ml of water in the morning in a double-blind manner as dry mixtures in sealed portion size bags of similar shape and size.
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicentre randomized double-blinded controlled trial lasting 20 weeks with two study periods. The first 12 weeks will constitute a treatment period with BSE (BSE group) or placebo (Control group) depending on the randomization of the group allocation. After that, patients from both groups will be followed for another eigth weeks, called post-study observational period.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sulforaphane; Nutrition; Glucose control