- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02801448
Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes
Randomized Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sulforaphane binds to Keap1 in the cytosol, leading to nuclear translocation of this transcription factor. In the nucleus NRF2 induces the expression of a large number of anti-oxidative genes. Sulforaphane is contained at high concentration in broccoli sprout extracts (BSE). Human studies have been conducted using broccoli sprout products without complication. It is being tested for the treatment or prevention of cancer and inflammatory diseases in ~30 clinical trials without any serious adverse events reported. The low toxicity makes BSE ideal as a dietary supplement for preventing and treating T2D.
The investigators aim to study the clinical effect of sulforaphane on glucose tolerance in T2D patients. Sulforaphane will be given as BSE. BSE is a freeze-dried powder of an aqueous extract of broccoli sprouts that provides a consistent and stable source of sulforaphane. The investigators will use a parallel arm study design with patients receiving BSE or placebo. The randomization will be double-blind. The study will be done at one centre. Patients with BMI between 25-40 kg/m2 will be included. Another inclusion criterion is HbA1c 6-10%. Patients will be treated for 12 weeks to enable us to observe effects on HbA1c (HbA1c turn-over is 3 months).
Patients will come to a screening visit and if they give informed consent and are included they attend a second visit 2-3 weeks later.
The patients will undergo an oral glucose tolerance test (OGTT) before and after the 12-week treatment period. The reason for using OGTT rather than e.g. insulin clamps as the readout is that it is a harmless standard procedure that gives an integrated view of glucose tolerance.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Classified as type 2 diabetes
- Written informed consent
- Age: for men and women 35-75 years; for women below 75 years should be postmenopausal (defined as no menstrual bleeding since at least one year).
- Body mass index 25-40 kg/m2
- At screening visit : HbA1c 6-10 %, equivalent to 41-86 mmol/mol
- Currently treated with metformin or diet
Exclusion Criteria:
- Treatment with insulin, other anti-diabetic treatment given as injections or any oral anti-diabetic treatment except metformin
- Fasting blood glucose at screening > 15.0 mmol/L
- Active liver disease
- At screening or at any subsequent visit a level of aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) of more than three times the upper limit of the normal range
- Gastrointestinal ailments which may interfere with the ability to adequately absorb sulforaphane
- At screening visit creatinine > 130 µmol/L
- Coagulation disorder or current anti-coagulant therapy with warfarin, which may be affected by the BSE
- Diagnosed with a cardiovascular disease or event within 6 months prior to enrolment
- Systemic glucocorticoid treatment
- Herbal treatment, defined as food supplement (except multivitamin treatment) with herbal or vegetable extracts that may contain sulforaphane
- Allergy to broccoli
- Mental disorder making the patient unable to understand the study information
- Participation in other clinical trial which may affect the outcome of the present study
- Any other physical or psychiatric condition or treatment that in the judgment of the investigator makes it difficult to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo containing maltodextrine but no active sulforaphane
|
Maltodextrine-based placebo without sulforaphane
|
Active Comparator: BSE
Broccoli sprout extract once daily for 12 weeks
|
sulforaphane-containing broccoli sprout extracts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delta-HbA1c
Time Frame: 12 weeks
|
difference in HbA1c before and after treatment
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delta-fasting blood glucose
Time Frame: 12 weeks
|
difference in fasting blood glucose before and after treatment
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anders Rosengren, Lund University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSE1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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