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

NCT04858854 | Completed

• 1 other identifier: 2020-06468
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Chronic Kidney Disease Stage 3B; Chronic Kidney Disease stage4; Diabetes Mellitus, Type 2

Keywords

Sulforaphane; Nutrition; Glucose control

Outcome Measures

Primary Outcomes (1)

• Fasting serum glucose

  Change in fasting serum glucose from baseline at week 12

  Baseline, Week 12

Secondary Outcomes (13)

• C-reactive protein (CRP)

  Baseline, Week 12 and Week 20

• Interleukin-6 (IL6)

  Baseline, Week 12 and Week 20

• Tumor necrosis alpha (TNF)

  Baseline, Week 12 and Week 20

• Interleukin 10

  Baseline, Week 12 and Week 20

• Advanced oxidation protein products (AOPP)

  Baseline, Week 12 and Week 20

Study Arms (2)

BSE group (Broccoli sprout group)

ACTIVE COMPARATOR

The BSE Group will receive 50 µmmol/day of sulforaphane administered by 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.

Other: Sulforaphane, administered as Broccoli sprout extract

Control group

PLACEBO COMPARATOR

The Control Group will receive a placebo (maltodextrin sprayed with copper-chlorophyllin) for 12 weeks.

Other: Sulforaphane, administered as Broccoli sprout extract

Interventions

Sulforaphane, administered as Broccoli sprout extract OTHER

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.

BSE group (Broccoli sprout group); Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a GFR 15-45 ml/min/1.73 m2, DM type 2, age \>18 years old, able to read and understand Swedish.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Lantmännen: collaborator

Study Sites (12)

Gävle Hospital

Gävle, 80187, Sweden

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 41345, Sweden

Location

Linköpings universitet

Linköping, 58183, Sweden

Location

Skånes University Hospital Sus

Lund, 22185, Sweden

Location

Skånes universitetssjukhus

Malmo, 20502, Sweden

Location

Karolinska Institutet

Stockholm, 14134, Sweden

Location

Danderyds sjukhus AB

Stockholm, 18288, Sweden

Location

Norrlands Universitetssjukhus

Umeå, 90185, Sweden

Location

Akademiska sjukhuset

Uppsala, 75185, Sweden

Location

Hallands Hospital Varberg

Varberg, 43281, Sweden

Location

Västmanlands Hospital Västerås

Västerås, 72189, Sweden

Location

Västervikssjukhus

Västervik, 59333, Sweden

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Peter x Stenvinkel, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Carla Avesani, PhD

  Karolinska Institutet

  STUDY CHAIR

• Marie Evans, MD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 26, 2021
• Study Start: October 10, 2021
• Primary Completion: December 30, 2022
• Study Completion: May 18, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (12)