Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes
|Diabetes Mellitus, Non-Insulin-Dependent||Drug: sulforaphane Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes|
- Delta-HbA1c [ Time Frame: 12 weeks ]difference in HbA1c before and after treatment
- Delta-fasting blood glucose [ Time Frame: 12 weeks ]difference in fasting blood glucose before and after treatment
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02801448
|Principal Investigator:||Anders Rosengren||Lund University|