BSE on Blood Glucose

Blood Glucose, High Clinical Trial

Official title:

Effect of BSE on Blood Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763240
• Other study ID #: BSE
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Glucose, High
• Hyperglycemia

Intervention

Dietary Supplement:
• BSE
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.
• Placebo
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.

Locations

Country	Name	City	State
Sweden	Gothia Forum	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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