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BSE on Blood Glucose

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ClinicalTrials.gov Identifier: NCT03763240
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Region Skane

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.

Condition or disease Intervention/treatment Phase
Blood Glucose, High Dietary Supplement: BSE Dietary Supplement: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel arm study with placebo and intervention substance
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Effect of BSE on Blood Glucose
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: 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 Comparator: 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.
Dietary Supplement: 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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763240


Contacts
Contact: Anders Rosengren, MD PhD +46705316704 anders.rosengren@gu.se

Locations
Sweden
Gothia Forum Recruiting
Gothenburg, Sweden, 41345
Contact: Helen Svanström, Nurse    031-3439919    rekrytering.ctc.su@vgregion.se   
Sponsors and Collaborators
Region Skane
Göteborg University

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03763240     History of Changes
Other Study ID Numbers: BSE
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents