Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2018-09-01
2020-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
The randomization list is kept with the local pharmacy during the entire study. Sealed envelopes with randomization information for each participant are send to investigator and may be opened in case of emergency.
Study Groups
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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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
75 Years
ALL
Yes
Sponsors
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Göteborg University
OTHER
Region Skane
OTHER
Responsible Party
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Locations
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Gothia Forum
Gothenburg, , Sweden
Countries
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References
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Dwibedi C, Axelsson AS, Abrahamsson B, Fahey JW, Asplund O, Hansson O, Ahlqvist E, Tremaroli V, Backhed F, Rosengren AH. Effect of broccoli sprout extract and baseline gut microbiota on fasting blood glucose in prediabetes: a randomized, placebo-controlled trial. Nat Microbiol. 2025 Mar;10(3):681-693. doi: 10.1038/s41564-025-01932-w. Epub 2025 Feb 10.
Other Identifiers
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BSE
Identifier Type: -
Identifier Source: org_study_id