BSE on Blood Glucose

Region Skane

Status: Completed

Conditions: Blood Glucose, High

Treatments: Dietary Supplement: BSE; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03763240

BSE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

BSE

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: BSE

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo