Clinical trial NCT03763240: BSE on Blood Glucose
Official title: Effect of BSE on Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose, High
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2018-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel arm study with placebo and intervention substance
Primary purpose: TREATMENT

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 could be used to improve glucose control in drug-naïve pre-diabetic individuals. The participants will receive BSE or placebo in a randomized double-blind parallel arm study. The participants will take their study compound once daily over 12 weeks. The primary study variable is fasting glucose.

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 could be used to improve glucose control in drug-naïve pre-diabetic individuals. The participants will receive BSE or placebo in a randomized double-blind parallel arm study. The participants will take their study compound once daily over 12 weeks. The primary study variable is fasting glucose.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The primary effect variable is venous fasting blood glucose.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change of long-term blood glucose concentration measured as glycated hemoglobin at 12 weeks
timeFrame: 12 weeks
measure: Change of insulin resistance measured as HOMA-IR at 12 weeks
timeFrame: 12 weeks
measure: Change of insulin secretion measured as HOMA-B at 12 weeks
timeFrame: 12 weeks
measure: Change of body mass index at 12 weeks
timeFrame: 12 weeks
measure: Change of total cholesterol at 12 weeks
timeFrame: 12 weeks
measure: Change of LDL cholesterol at 12 weeks
timeFrame: 12 weeks
measure: Change of HDL cholesterol at 12 weeks
timeFrame: 12 weeks
measure: Change of triglycerides at 12 weeks
timeFrame: 12 weeks
measure: Change of fatty liver index at 12 weeks
timeFrame: 12 weeks
measure: Change of insulin clearance at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Gothia Forum
Study officials:
References: