Status:
COMPLETED
BSE on Blood Glucose
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Göteborg University
Conditions:
Blood Glucose, High
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
Here we will investigate the effect of sulforaphane, provided as a broccoli sprout extract (BSE) on blood glucose in pre-diabetic individuals without metformin treatment. This will address whether BSE...
Detailed Description
Here we will investigate the effect of sulforaphane, provided as a broccoli sprout extract (BSE) on blood glucose in pre-diabetic individuals without metformin treatment. This will address whether BSE...
Eligibility Criteria
Inclusion
- Impaired fasting glucose, defined as fasting blood glucose 6.1-6.9 mM.
- Written informed consent
- Age 35-75 years. Participating women of fertile age must have no current pregnancy, which will be assessed by pregnancy test.
- Body mass index 27-45 kg/m2
Exclusion
- Diagnosed with diabetes mellitus according to the WHO criteria
- Anti-diabetic medication
- 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, which may be affected by the BSE
- Diagnosed with a cardiovascular disease or known cardiovascular event, transient ischemic attack, coronary by-pass surgery or other coronary vessel intervention 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 affect blood glucose
- Allergy to broccoli
- Participant 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.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03763240
Start Date
September 1 2018
End Date
December 1 2020
Last Update
December 16 2024
Active Locations (1)
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1
Gothia Forum
Gothenburg, Sweden, 41345