Blood Glucose, HighNCT03763240
BSE on Blood Glucose
A study testing BSE in people with Blood Glucose, High, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, High
- What is being tested?
- BSE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of BSE on Blood Glucose
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.
Read the detailed 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.
- Conditions
- Blood Glucose, High
- Being tested
- BSE, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSEDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (10)
Change of long-term blood glucose concentration measured as glycated hemoglobin at 12 weeks
Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) in mmol/mol at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Change of insulin resistance measured as HOMA-IR at 12 weeks
Intraindividual change of insulin resistance measured as Homeostasis model assessment-2 estimates of insulin resistance (HOMA-IR) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Change of insulin secretion measured as HOMA-B at 12 weeks
Intraindividual change of insulin secretion measured as Homeostasis model assessment-2 estimates of beta-cell function (HOMA-B) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Change of body mass index at 12 weeks
Intraindividual change of body mass index (BMI), measured as the body weight in kilogram divided by the square of the length in meter, at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Change of total cholesterol at 12 weeks
Intraindividual change of total cholesterol concentration in plasma (measured in mmol/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Change of LDL cholesterol at 12 weeks
Intraindividual change of low-density lipoprotein (LDL) cholesterol concentration in plasma (measured in mmol/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Change of HDL cholesterol at 12 weeks
Intraindividual change of high-density lipoprotein (HDL) cholesterol concentration in plasma (measured in mmol/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Change of triglycerides at 12 weeks
Intraindividual change of serurm triglyceride concentration (measured in mmol/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Change of fatty liver index at 12 weeks
Intraindividual change of fatty liver index (based on body mass index in kg per square meter, waist circumference in centimeter, triglycerides in mmol/l and gamma-glutamyl transferase in microkat/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Change of insulin clearance at 12 weeks
Intraindividual change of insulin clearance (measured as fasting plasma C-peptide concentration in nmol/l divided by fasting plasma insulin concentration mIE/l) at 12 weeks relative to baseline compared between participants treated with BSE and placebo, respectively.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Sep 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Glucose, HighStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel arm study with placebo and intervention substance
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763240
- Sponsor's protocol ID
- BSE
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2018
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39929977
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BSE on Blood Glucose
- ClinicalTrials.gov ID
- NCT03763240
- Acronym / sponsor ID
- BSE
- Conditions
- Blood Glucose, High
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel arm study with placebo and intervention substance
| Arm | Type | Receives |
|---|---|---|
| BSE | Active comparator | Dietary Supplement: BSESulforaphane-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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSEBSE 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. | Dietary supplement | BSE |
| PlaceboPlacebo 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. | Dietary supplement | Placebo |
Primary outcome
The primary effect variable is venous fasting blood glucose.
Time frame: 12 weeks
Participants will be analysed using intraindividual one-tailed comparisons before and after treatment and compared between the placebo and BSE arms
10 secondary outcomes
Change of long-term blood glucose concentration measured as glycated hemoglobin at 12 weeks
Time frame: 12 weeks
Change of insulin resistance measured as HOMA-IR at 12 weeks
Time frame: 12 weeks
Change of insulin secretion measured as HOMA-B at 12 weeks
Time frame: 12 weeks
Change of body mass index at 12 weeks
Time frame: 12 weeks
Change of total cholesterol at 12 weeks
Time frame: 12 weeks
Change of LDL cholesterol at 12 weeks
Time frame: 12 weeks
Change of HDL cholesterol at 12 weeks
Time frame: 12 weeks
Change of triglycerides at 12 weeks
Time frame: 12 weeks
Change of fatty liver index at 12 weeks
Time frame: 12 weeks
Change of insulin clearance at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 39929977Dwibedi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BSE in people with Blood Glucose, High, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary effect variable is venous fasting blood glucose. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03763240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.