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
|Condition or disease||Intervention/treatment||Phase|
|Blood Glucose, High||Dietary Supplement: BSE Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel arm study with placebo and intervention substance|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
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.
|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|
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.
- 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
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
|Contact: Anders Rosengren, MD PhDemail@example.com|
|Gothenburg, Sweden, 41345|
|Contact: Helen Svanström, Nurse 031-3439919 firstname.lastname@example.org|