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Completed

NCT Number: NCT03763240

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.

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Key information

Conditions

Blood Glucose, High

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gothia Forum

Gothenburg, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Change of body mass index at 12 weeks

    Time frame: 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.

  5. Change of total cholesterol at 12 weeks

    Time frame: 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.

  6. Change of LDL cholesterol at 12 weeks

    Time frame: 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.

  7. Change of HDL cholesterol at 12 weeks

    Time frame: 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.

  8. Change of triglycerides at 12 weeks

    Time frame: 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.

  9. Change of fatty liver index at 12 weeks

    Time frame: 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.

  10. Change of insulin clearance at 12 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Göteborg University

Registry information

Official study title

Effect of BSE on Blood Glucose

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2018
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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