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Chronic Kidney Disease Stage 3BINITIATENCT04858854

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

A study testing Sulforaphane, administered as Broccoli sprout extract in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease stage4, run by Karolinska Institutet at 12 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Sulforaphane, administered as Broccoli sprout extract
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
12 sitesSweden
Study dates
10 Oct 2021to 18 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Sweden12 sites

  • Gävle Hospital

    Gävle, 80187

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41345

  • Linköpings universitet

    Linköping, 58183

  • Skånes University Hospital Sus

    Lund, 22185

  • Skånes universitetssjukhus

    Malmö, 20502

  • Karolinska Institutet

    Stockholm, 14134

  • Danderyds sjukhus AB

    Stockholm, 18288

  • Norrlands Universitetssjukhus

    Umeå, 90185

  • Akademiska sjukhuset

    Uppsala, 75185

  • Hallands Hospital Varberg

    Varberg, 43281

  • Västmanlands Hospital Västerås

    Västerås, 72189

  • Västervikssjukhus

    Västervik, 59333

Other trials in Sweden

About this study

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.

Being tested
Sulforaphane, administered as Broccoli sprout extract
Keywords
Sulforaphane, Nutrition, Glucose control
Medical subject headings
Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sulforaphane, administered as Broccoli sprout extractOther

    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.

Study groups in NCT04858854
Study groupRoleWhat they receive
BSE group (Broccoli sprout group)Active comparatorThe 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.
Receives: Other: Sulforaphane, administered as Broccoli sprout extract
Control groupPlacebo comparatorThe Control Group will receive a placebo (maltodextrin sprayed with copper-chlorophyllin) for 12 weeks.
Receives: Other: Sulforaphane, administered as Broccoli sprout extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting serum glucose

    Change in fasting serum glucose from baseline at week 12

    Measured: Baseline, Week 12

Secondary outcomes (13)

  1. C-reactive protein (CRP)

    Inflammatory marker

    Measured: Baseline, Week 12 and Week 20

  2. Interleukin-6 (IL6)

    Inflammatory marker

    Measured: Baseline, Week 12 and Week 20

  3. Tumor necrosis alpha (TNF)

    Inflammatory marker

    Measured: Baseline, Week 12 and Week 20

  4. Interleukin 10

    Inflammatory marker

    Measured: Baseline, Week 12 and Week 20

  5. Advanced oxidation protein products (AOPP)

    Oxidative stress

    Measured: Baseline, Week 12 and Week 20

  6. 8-hydroxydeoxyguanosine (8-OHdG)

    Oxidative stress

    Measured: Baseline, Week 12 and Week 20

  7. Urinary albumin creatinine ratio (ACR)

    Proteinuria

    Measured: Baseline, Week 12 and Week 20

  8. Indoxyl-sulfate (IS)

    Uremic toxins

    Measured: Baseline, Week 12 and Week 20

  9. Trimethylamine N-oxide (TMAO)

    Uremic toxins

    Measured: Baseline, Week 12 and Week 20

  10. P-cresyl sulfate (IPC)

    Uremic toxins

    Measured: Baseline, Week 12 and Week 20

  11. Oral glucose tolerance test

    Performed in patients not using insulin at the local participating Hospital Chemical

    Measured: Baseline, Week 12 and Week 20

  12. Fasting HbA1c

    Fasting HbA1c

    Measured: Baseline, Week 12, Week 20 and week 20

  13. Fasting insulin

    Fasting insulin

    Measured: Baseline, Week 4, Week 8, Week 12 and Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2021
  2. Study start10 Oct 2021
  3. Primary completion30 Dec 2022
  4. Study completion18 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04858854
Sponsor's protocol ID
2020-06468
Acronym
INITIATE
Status last verified
Mar 2024
First submitted
9 Apr 2021
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sulforaphane, administered as Broccoli sprout extract in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease stage4, run by Karolinska Institutet at 12 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting serum glucose (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04858854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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