Shanghai Meiji Health Science and Technology Co., Ltd
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- Changes in anthropometrix indices during the study
研究概览
简要总结
Investigators performed a randomized double-blind trial to determine the effects of long-term NnEx ingestion in patients with overweight or obesity. Ninety-five participants (23<BMI<30 kg/m2) were randomly allocated to three groups: a control group, a 1 g/day NnEx group, and a 2 g/day NnEx group. The effects of the consumption of 2 g/day or 1 g/day NnEx for 12 weeks on indices of adiposity and fasting blood metabolic parameters were compared with those of no consumption of NnEx.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a body mass index (BMI) of 23-30 kg/m2
- •Has no history of using any antidiabetic medication
- •Absence of liver, kidney, or heart disease
- •Absence of food allergy and daily tea consumption <2 L
- •Meet all of the above criteria and to follow the instructions given during the study.
排除标准
- •Testing delayed for >1 week without justification
- •Difficulty attending the hospital on the required days
- •Lack of data regarding the times of beverage consumption for over 5% of the study
- •Abnormal overeating
- •Test results believed to be unreliable because of the lack of provision of diet and exercise reports during the fasting period
- •Difficulty drawing blood
- •Poor confidence in the test data
研究组 & 干预措施
control group
During the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (0g NnEx) per day with or after meals.
干预措施: Nelumbo nucifera Leaf Extract (Dietary Supplement)
low concentration of NnEx group
During the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (1g NnEx) per day with or after meals.
干预措施: Nelumbo nucifera Leaf Extract (Dietary Supplement)
high concentration of NnEx group
During the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (2g NnEx) per day with or after meals.
干预措施: Nelumbo nucifera Leaf Extract (Dietary Supplement)
结局指标
主要结局
Changes in anthropometrix indices during the study
时间窗: baseline, 6 weeks, 12 weeks
weight in kilograms
次要结局
- Changes in fasting biochemical indices during the study(baseline, 6 weeks, 12 weeks)
研究者
Zai-Si Ji, phD
Principal Investigator
Shanghai Meiji Health Science and Technology Co., Ltd.