Effect of Broccoli Sprout Extract in Patients With Chronic Kidney Disease With Diabetes Type 2

Diabetes Mellitus, Type 2 Clinical Trial

— INITIATE  

Official title:

Effect of Broccoli Sprout Extract in Patients With Chronic Kidney Disease With Diabetes Type 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04858854
• Other study ID #: 2020-06468
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 3B
• Chronic Kidney Disease stage4
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic

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