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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 : August 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Drug: sulforaphane Drug: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes
Study Start Date : September 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo containing maltodextrine but no active sulforaphane
Drug: Placebo
Maltodextrine-based placebo without sulforaphane
Active Comparator: BSE
Broccoli sprout extract once daily for 12 weeks
Drug: sulforaphane
sulforaphane-containing broccoli sprout extracts


Outcome Measures

Primary Outcome Measures :
  1. Delta-HbA1c [ Time Frame: 12 weeks ]
    difference in HbA1c before and after treatment


Secondary Outcome Measures :
  1. Delta-fasting blood glucose [ Time Frame: 12 weeks ]
    difference in fasting blood glucose before and after treatment


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801448


Sponsors and Collaborators
Anders Rosengren, MD PhD
Investigators
Principal Investigator: Anders Rosengren Lund University
More Information

Responsible Party: Anders Rosengren, MD PhD, MD PhD, Region Skane
ClinicalTrials.gov Identifier: NCT02801448     History of Changes
Other Study ID Numbers: BSE1
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents