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Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02801448
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Anders Rosengren, MD PhD, Region Skane

Tracking Information
First Submitted Date  ICMJE June 12, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date June 29, 2020
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Delta-HbA1c [ Time Frame: 12 weeks ]
difference in HbA1c before and after treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Delta-fasting blood glucose [ Time Frame: 12 weeks ]
difference in fasting blood glucose before and after treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes
Official Title  ICMJE Randomized Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes
Brief Summary Type 2 diabetes (T2D) results from a combination of insufficient insulin secretion from pancreatic islets and insulin resistance of target cells. The investigators have extensive pre-clinical data suggesting that BSE through its high content of the isothiocyanate sulforaphane improves hepatic insulin sensitivity. BSE as a dietary supplement could therefore benefit both patients with T2D and individuals at risk for the disease. BSE-containing sulforaphane is suggested to activate Nuclear factor-like 2 (NRF2). The investigators aim to study the clinical effect of using BSE as a dietary supplement on glucose tolerance and insulin sensitivity.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Non-Insulin-Dependent
Intervention  ICMJE
  • Drug: sulforaphane
    sulforaphane-containing broccoli sprout extracts
  • Drug: Placebo
    Maltodextrine-based placebo without sulforaphane
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo containing maltodextrine but no active sulforaphane
    Intervention: Drug: Placebo
  • Active Comparator: BSE
    Broccoli sprout extract once daily for 12 weeks
    Intervention: Drug: sulforaphane
Publications * Axelsson AS, Tubbs E, Mecham B, Chacko S, Nenonen HA, Tang Y, Fahey JW, Derry JMJ, Wollheim CB, Wierup N, Haymond MW, Friend SH, Mulder H, Rosengren AH. Sulforaphane reduces hepatic glucose production and improves glucose control in patients with type 2 diabetes. Sci Transl Med. 2017 Jun 14;9(394). pii: eaah4477. doi: 10.1126/scitranslmed.aah4477.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 14, 2016)
103
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02801448
Other Study ID Numbers  ICMJE BSE1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anders Rosengren, MD PhD, Region Skane
Study Sponsor  ICMJE Anders Rosengren, MD PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anders Rosengren Lund University
PRS Account Region Skane
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP