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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gothia Forum | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39929977 | Derived | 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. |
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Parallel arm study with placebo and intervention substance
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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.
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| 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. |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 weeks |