Effect of BSE on Blood Glucose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The primary effect variable is venous fasting blood glucose.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The primary effect variable is venous fasting blood glucose.
时间窗: 12 weeks
Participants will be analysed using intraindividual one-tailed comparisons before and after treatment and compared between the placebo and BSE arms
次要结局
- Change of long-term blood glucose concentration measured as glycated hemoglobin at 12 weeks(12 weeks)
- Change of insulin resistance measured as HOMA-IR at 12 weeks(12 weeks)
- Change of insulin secretion measured as HOMA-B at 12 weeks(12 weeks)
- Change of body mass index at 12 weeks(12 weeks)
- Change of total cholesterol at 12 weeks(12 weeks)
- Change of triglycerides at 12 weeks(12 weeks)
- Change of fatty liver index at 12 weeks(12 weeks)
- Change of LDL cholesterol at 12 weeks(12 weeks)
- Change of HDL cholesterol at 12 weeks(12 weeks)
- Change of insulin clearance at 12 weeks(12 weeks)