An Eight-week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Persimmon Leaf Extract on Anti-diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Fasting and postprandial plasma glucose
研究概览
简要总结
The investigators performed a 8-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of persimmon leaf extract on blood glucose. The investigators measures changes in diabetes associated parameters, including fasting blood glucose, postprandial blood glucose, insulin, C-peptide and HbA1c.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-75 years
- •Fasting blood glucose (FPG) 100~140 mg/dL or postprandial blood glucose (PPG) 140~250 mg/dL
排除标准
- •FPG more than 140 mg/dL
- •2h PPG more than 200 mg/dL
- •Type 1 diabetes or HbA1c more than 9.0%
- •treatment with corticosteroids within the past 4 weeks
- •cardiovascular disease
研究组 & 干预措施
Treatment sequence 1
PLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks.
干预措施: Persimmon leaf extract (Dietary Supplement)
Treatment sequence 1
PLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks.
干预措施: Placebo (Dietary Supplement)
Treatment sequence 2
Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks.
干预措施: Persimmon leaf extract (Dietary Supplement)
Treatment sequence 2
Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Fasting and postprandial plasma glucose
时间窗: baseline day 57, 85 and 141
次要结局
- C-peptide(baseline and day 57, 85 and 141)
- Markers of Inflammation(baseline and day 57, 85 and 141)
- resistin(baseline and day 57, 85 and 141)
- Interleukin-6 (IL-6)(baseline and day 57, 85 and 141)
- Glycated hemoglobin (HbA1c)(baseline and day 57, 85 and 141)
- adiponectin(baseline and day 57, 85 and 141)
- leptin(baseline and day 57, 85 and 141)
- Fasting plasma insulin(baseline and day 57, 85 and 141)
- Tumor necrosis factor alpha (TNF-α)(baseline and day 57, 85 and 141)
- Monocyte chemoattractant protein-1 (MCP-1)(baseline and day 57, 85 and 141)
研究者
Soo-Wan Chae
Professor
Chonbuk National University Hospital