NCT03956914已完成不适用
A 8-weeks, Randomized, Double-blind, Placebo-Controlled, Cross-Over Clinical Trials to Evaluated the Efficacy and Safety of Deep Sea Water on Blood Glucose Level
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Changes of blood glucose
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia
详细描述
This study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fasting plasma glucose concentration of 100-140 mg/dL or 2h-postprandial plasma glucose concentration of 140 ~199 mg/dL
排除标准
- •Patients with type 1 or type 2 diabetes
- •HbA1c ≥9.0%
- •Weight decreased by more than 10% within past 3 months
- •Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
- •Hypoglycemic agent, obesity medicine, lipid lowering agent within past 6 months or functional food within past 2 month
- •Subjects who have taken corticosteroid within past 1 months
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test by show the following results
- •Serum AST (aspartate aminotransferase) or ALT (alanine aminotransferase) > 2 times the upper limit of normal range
- •Serum Creatinine > 2.0 mg/dl
- •Pregnancy or breast feeding
- •If a woman of childbearing doesn't accept the implementation of appropriate contraception
- •Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc
结局指标
主要结局
Changes of blood glucose
时间窗: Baseline, 8 weeks
Concentration of fasting and postprandial glucose during OGTT (oral glucose tolerance test) were assessed before and after the intervention
次要结局
- Weight(Baseline, 8 weeks)
- Changes of blood insulin(Baseline, 8 weeks)
- Waist circumference(Baseline, 8 weeks)
- C-pepetide(Baseline, 8 weeks)
- Homeostatic model assessment - insulin resistance (HOMA-IR)(Baseline, 8 weeks)
- LDL-cholesterol(Baseline, 8 weeks)
- HbA1c(Baseline, 8 weeks)
- Triglyceride(Baseline, 8 weeks)
- HDL-cholesterol(Baseline, 8 weeks)
- BMI(Baseline, 8 weeks)
- Body fat mass(Baseline, 8 weeks)
- Percent of body fat mass(Baseline, 8 weeks)
- Total cholesterol(Baseline, 8 weeks)
- Waist-hip ratio (WHR)(Baseline, 8 weeks)
研究者
Soo-Wan Chae
Principal Investigator
Chonbuk National University Hospital
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