NCT04298970已完成不适用
Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- iAUC
研究概览
简要总结
Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on patients with type 2 diabetes.
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)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes, dietary treatment and/or with oral anti-diabetics
- •Diabetes debut > 30 year
- •Plasma fasting blood glucose > 4mM and < 12 mM
- •HbA1c > 43 and ≤ 108 mmol/mol
- •BMI between 23-40 kg/m2
- •Fasting triglyceride > 1.7 mmol/L and HDL-cholesterol, men: < 1.03 mmol/L and women: 1.29 mmol/L.
排除标准
- •Participating or have been participating in other clinical trials within the last 2 months.
- •In treatment with insulin, systemic glucocorticoids, glitazones or GLP-1 analogs.
- •Cardiovascular-, physiological-, neurological-, and/or kidney diseases.
- •Alcohol- or pill abuse.
- •Acute diseases.
- •Blood pressure ≥ 160/100
- •Pregnant or breastfeeding women.
结局指标
主要结局
iAUC
时间窗: Throughout the study (up to 1 year)
The blood glucose incremental area under curve, OGTT
次要结局
未报告次要终点
研究者
Per Bendix Jeppesen
Associate. Prof, Phd, Diabetes and hormone diseases
University of Aarhus
研究点 (2)
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