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临床试验/NCT05680532
NCT05680532已完成不适用

The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori

Chung Shan Medical University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Glycemic indices

研究概览

简要总结

The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori). Through checking various parameters including anthropometric, antioxidants, and CDR.

详细描述

The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori).

Preclinical studies (In vitro model) were conducted using 3T3-L1 adipocyte cells to check the anti-adhesion activity of BR.

For the clinical trial, a total of 21 obese mild AZ patients were recruited and separated into 2 groups: Experimental (BR group) and Placebo group.

Experimental group and Placebo group subjects were requested to take either 50 g of BR or 50 g of dextrin respectively for 4 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •BMI ≧ 27, Waist circumference: men ≧ 90cm, women ≧ 80cm,
  • •Body fat: male ≧ 25%, female ≧ 30%,
  • •UBT 13C test value> 10‰ (H. pylori (+)),
  • •CDR (clinical dementia rating) = 0.5

排除标准

  • •Severe chronic diseases (liver disease, cardiovascular disease, kidney disease)
  • •Alcohol abuse
  • •Smoking habit
  • •Taking berry-related supplementation or any known allergies related to berries.
  • •Subjects with prior history of H. pylori infection were treated with triple therapy.

研究组 & 干预措施

Placebo group

Placebo Comparator

Placebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks.

干预措施: Placebo (Other)

BR group

Experimental

Experimental group AZ subjects were requested to take 50 g of BR powder dissolved in 240 ml of water for 4 weeks.

干预措施: Black raspberry (Dietary Supplement)

结局指标

主要结局

Glycemic indices

时间窗: 8 weeks

No significant changes in any of the glycemic indices

Anthropometric parameters

时间窗: 8 weeks

BMI were significantly altered

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chin Kun Wang

Professor

Chung Shan Medical University

研究点 (1)

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