BSE on Blood Glucose

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of BSE on Blood Glucose

Conditions
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Blood Glucose, High

Intervention / Treatment
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* Dietary Supplement: BSE
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel arm study with placebo and intervention substance
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BSE<br>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. | Dietary Supplement: BSE<br>* BSE powder will be provided as dry mixtures in sealed, non-transparent portion size bags. Each BSE bag contains 150 μmole, equal to 0.26 g, sulforaphane at a minimum. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning. BSE should be stored at room temperature in dry conditions. The doses of sulforaphane contained in the BSE is not possible to get by eating fresh broccoli, thus it has to be given as an extract.<br>|
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: Placebo<br>* Placebo powder will be provided as dry mixtures in sealed, non-transparent portion size bags. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary effect variable is venous fasting blood glucose. | Participants will be analysed using intraindividual one-tailed comparisons before and after treatment and compared between the placebo and BSE arms | 12 weeks |