BSE on Blood Glucose

NCT03763240 | Completed

• 1 other identifier: BSE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Glucose, High

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change of long-term blood glucose concentration measured as glycated hemoglobin at 12 weeks

  12 weeks

• Change of insulin resistance measured as HOMA-IR at 12 weeks

  12 weeks

• Change of insulin secretion measured as HOMA-B at 12 weeks

  12 weeks

• Change of body mass index at 12 weeks

  12 weeks

• Change of total cholesterol at 12 weeks

  12 weeks

Study Arms (2)

BSE

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

BSE DIETARY_SUPPLEMENT

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.

BSE

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead
• Göteborg University: collaborator

Study Sites (1)

Gothia Forum

Gothenburg, 41345, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39929977 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each participant receives the kit that corresponds to his/her study ID. The randomization is blind to both participants and the Investigator during the study. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel arm study with placebo and intervention substance

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: September 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)