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临床试验/NCT03204552
NCT03204552已完成不适用

Dalin Tzu Chi General Hospital

Dalin Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 6,002 人开始时间: 2007年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,002
试验地点
1
主要终点
Diabetes

研究概览

简要总结

To determine the effect of diet and lifestyle, particularly vegetarian diets on chronic degenerative disease outcomes in a cohort of Taiwanese Buddhists participants

详细描述

How did the study come about? The Tzu Chi Health Study (TCHS) began in 2007 with the goal of investigating the role of a vegetarian diet on health outcomes.

Founded in 1966, the Buddhist Tzu Chi Foundation is a leading humanitarian organization with a worldwide base of more than 5 million supporters and volunteers. Tzu means "compassion" and Chi means "relief". The organization has chapters in 47 countries on six continents, which carry out the missions of Charity, Medicine, Education, and Humanistic Culture, and delivered aid to 67 countries, to date. Today in Taiwan, there are six Tzu Chi hospitals: four large teaching hospitals (in Hualien, Dalin, Taipei, and Taichung), and two small community hospitals (in Kuanshan and Yuli). Tzu Chi has established in Taiwan a comprehensive educational system from pre-school to graduate school, including Tzu Chi University (housing now a leading medical school in Taiwan) and operates Da Ai (Great Love) TV, a global satellite television station that runs in part on proceeds from its on-going recycling program.

For reasons of compassion and environmental conservation, a vegetarian diet is suggested, but not required, for Tzu Chi Commissioners. This population of Commissioners is a non-smoking, non-drinking population, with a wide range of dietary practice: about 30% are vegetarians, 38% partial vegetarians, and 32% omnivores. A free comprehensive health examination is available for Tzu Chi commissioners at Tzu Chi hospitals every two years. TCHS was established at Dalin Tzu Chi Hospital, where both Commissioners and patients coming for health examinations have been invited to participate in the study.

This study provides a unique opportunity to examine the health of East Asian Vegetarians. Much evidence for the health effects of a vegetarian diet are currently from western populations, namely the Seventh Day Adventists and the British vegetarians, while there is very little evidence on East Asian vegetarians who consume a different vegetarian diet.

Who is in the sample? A total of 6002 subjects have enrolled in the study. More than 70% of the participants are Tzu Chi Commissioners. The female-to-male ratio is about 2:1.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult individuals who came to Dalin Tzu Chi Hospital for health examination between 2007 to
  • Willing to participate in the study, be interviewed on questionnaires on demographics, diet, and lifestyle; willing to release health examination data for study purpose, and willing to be followed-up on health outcome

排除标准

  • Participants less than 18 years old.

结局指标

主要结局

Diabetes

时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 years

Diabetes incidence as determined through biochemical markers (fasting blood sugar, HbA1C), disease follow-up questionnaire, and medical records

Change in BMI

时间窗: The above outcomes would be measured at baseline, 3rd year, and 6th year

Change in BMI (calculated through height and weigh)

Fatty liver

时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 years

Fatty liver incidence as assessed through ultrasonography, disease follow-up questionnaire, and medical records

Change in cardiometabolic health markers

时间窗: The above outcomes would be measured at baseline, 3rd year, and 6th year

plasma lipids (cholesterol, triglyceride), pulse wave velocity, blood pressures; these markers may be combined to calculate metabolic syndrome or other scores representing metabolic health

次要结局

未报告次要终点

研究者

发起方
Dalin Tzu Chi General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tina H. T. Chiu

Nutritionist

Dalin Tzu Chi General Hospital

研究点 (1)

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