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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04858854
Other study ID # 2020-06468
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2021
Est. completion date May 18, 2023

Study information

Verified date March 2024
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 18, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients with a GFR 15-45 ml/min/1.73 m2, DM type 2, age >18 years old, able to read and understand Swedish. Exclusion Criteria: - Use of metformin, use of warfarin, levels of ASAT, ALAT more than three times the upper limit at screening or at any subsequent visit, kidney transplantation, inflammatory bowel disease, celiac disease, malignant diseases (except skin basalioma) in the previous 3 years, and any other condition that the treating doctor believes is contraindicated; allergy to broccoli; participation in another clinical trial which may affect the outcome of the present study; not to understand the study information.

Study Design


Intervention

Other:
Sulforaphane, administered as Broccoli sprout extract
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.

Locations

Country Name City State
Sweden Gävle Hospital Gävle
Sweden Sahlgrenska Universitetssjukhuset Göteborg
Sweden Linköpings universitet Linköping
Sweden Skånes University Hospital Sus Lund
Sweden Skånes universitetssjukhus Malmö
Sweden Danderyds sjukhus AB Stockholm
Sweden Karolinska Institutet Stockholm
Sweden Norrlands Universitetssjukhus Umeå
Sweden Akademiska sjukhuset Uppsala
Sweden Hallands Hospital Varberg Varberg
Sweden Västmanlands Hospital Västerås Västerås
Sweden Västervikssjukhus Västervik

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Lantmännen

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fasting serum glucose Change in fasting serum glucose from baseline at week 12 Baseline, Week 12
Secondary C-reactive protein (CRP) Inflammatory marker Baseline, Week 12 and Week 20
Secondary Interleukin-6 (IL6) Inflammatory marker Baseline, Week 12 and Week 20
Secondary Tumor necrosis alpha (TNF) Inflammatory marker Baseline, Week 12 and Week 20
Secondary Interleukin 10 Inflammatory marker Baseline, Week 12 and Week 20
Secondary Advanced oxidation protein products (AOPP) Oxidative stress Baseline, Week 12 and Week 20
Secondary 8-hydroxydeoxyguanosine (8-OHdG) Oxidative stress Baseline, Week 12 and Week 20
Secondary Urinary albumin creatinine ratio (ACR) Proteinuria Baseline, Week 12 and Week 20
Secondary Indoxyl-sulfate (IS) Uremic toxins Baseline, Week 12 and Week 20
Secondary Trimethylamine N-oxide (TMAO) Uremic toxins Baseline, Week 12 and Week 20
Secondary P-cresyl sulfate (IPC) Uremic toxins Baseline, Week 12 and Week 20
Secondary Oral glucose tolerance test Performed in patients not using insulin at the local participating Hospital Chemical Baseline, Week 12 and Week 20
Secondary Fasting HbA1c Fasting HbA1c Baseline, Week 12, Week 20 and week 20
Secondary Fasting insulin Fasting insulin Baseline, Week 4, Week 8, Week 12 and Week 20
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