BSE on Blood Glucose
- Conditions
- Blood Glucose, High
- Interventions
- Dietary Supplement: BSEDietary Supplement: Placebo
- Registration Number
- NCT03763240
- Lead Sponsor
- Region Skane
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BSE BSE Sulforaphane-containing broccoli sprout extract (BSE). The study product is BSE with standardized amounts of sulforaphane. BSE contains a mixture of maltodextrin as a bulking agent and copper chlorophyllin (E 141) as a food additive. BSE is a dried powder of an aqueous extract of broccoli sprouts that provides a consistent and stable source of sulforaphane. Placebo Placebo A mixture of maltodextrin and copper chlorophyllin will be used as placebo. The active compound and the placebo are the same except BSE. The placebo will look similar to the BSE-containing mixture.
- Primary Outcome Measures
Name Time Method The primary effect variable is venous fasting blood glucose. 12 weeks Participants will be analysed using intraindividual one-tailed comparisons before and after treatment and compared between the placebo and BSE arms
- Secondary Outcome Measures
Name Time Method Change of long-term blood glucose concentration measured as glycated hemoglobin at 12 weeks 12 weeks Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) in mmol/mol at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Change of insulin resistance measured as HOMA-IR at 12 weeks 12 weeks Intraindividual change of insulin resistance measured as Homeostasis model assessment-2 estimates of insulin resistance (HOMA-IR) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Change of insulin secretion measured as HOMA-B at 12 weeks 12 weeks Intraindividual change of insulin secretion measured as Homeostasis model assessment-2 estimates of beta-cell function (HOMA-B) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Change of body mass index at 12 weeks 12 weeks Intraindividual change of body mass index (BMI), measured as the body weight in kilogram divided by the square of the length in meter, at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Change of total cholesterol at 12 weeks 12 weeks Intraindividual change of total cholesterol concentration in plasma (measured in mmol/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Change of triglycerides at 12 weeks 12 weeks Intraindividual change of serurm triglyceride concentration (measured in mmol/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Change of fatty liver index at 12 weeks 12 weeks Intraindividual change of fatty liver index (based on body mass index in kg per square meter, waist circumference in centimeter, triglycerides in mmol/l and gamma-glutamyl transferase in microkat/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Change of LDL cholesterol at 12 weeks 12 weeks Intraindividual change of low-density lipoprotein (LDL) cholesterol concentration in plasma (measured in mmol/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Change of HDL cholesterol at 12 weeks 12 weeks Intraindividual change of high-density lipoprotein (HDL) cholesterol concentration in plasma (measured in mmol/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Change of insulin clearance at 12 weeks 12 weeks Intraindividual change of insulin clearance (measured as fasting plasma C-peptide concentration in nmol/l divided by fasting plasma insulin concentration mIE/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Trial Locations
- Locations (1)
Gothia Forum
🇸🇪Gothenburg, Sweden