Double-blind Randomized Cross-over Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Glycemic control
研究概览
简要总结
The study aims to investigate possible effects of per os Crocus Kozanis administration in children and adolescents with obesity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 10 year-old
- •Diagnosis of Obesity according to International Obesity Task Force Criteria
- •Presence of impaired glucose tolerance and/or impaired fasting glucose
排除标准
- •Overt diabetes (any type)
- •Diagnosis of any chronic disease
- •Previous use of dietary supplement with Crocus or Crocus Sativus
- •Administration of chronic medication
研究组 & 干预措施
Arm 2
Participants of Arm 2 are going to be administered metformin (1000mg once per day) for 12 weeks, wash-out period for 12 weeks and Crocus Kozanis (30mg twice per day) for 12 weeks.
干预措施: Crocus Kozanis (Dietary Supplement)
Arm 1
Participants of Arm 1 are going to be administered Crocus Kozanis for 12 weeks (30mg twice per day), wash-out period for 12 weeks and metformin (1000mg once per day) for 12 weeks.
干预措施: Crocus Kozanis (Dietary Supplement)
Arm 1
Participants of Arm 1 are going to be administered Crocus Kozanis for 12 weeks (30mg twice per day), wash-out period for 12 weeks and metformin (1000mg once per day) for 12 weeks.
干预措施: Metformin (Drug)
Arm 2
Participants of Arm 2 are going to be administered metformin (1000mg once per day) for 12 weeks, wash-out period for 12 weeks and Crocus Kozanis (30mg twice per day) for 12 weeks.
干预措施: Metformin (Drug)
Arm 3
Participants of Arm 3 are going to be administered placebo (5ml twice per day) for 12 weeks
干预措施: Placebo of Crocus Kozanis (Dietary Supplement)
结局指标
主要结局
Glycemic control
时间窗: Glycemic control will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).
Glycemic control will be assessed with glycated hemoglobin (ΗbA1c%) and/or oral glucose tolerance test (OGTT)
次要结局
- Lipidemic profile(Lipidemic profile will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).)
研究者
Assimina Galli-Tsinopoulou
Professor in Paediatrics-Paediatric Endocrinology
Aristotle University Of Thessaloniki