Vegetarian Diet and Chronic Degenerative Diseases
- Conditions
- DepressionUrinary Tract InfectionsCardiovascular DiseasesStrokeCataractGallstoneDementiaGout
- Interventions
- Other: Diet Exposure
- Registration Number
- NCT03470584
- Lead Sponsor
- Dalin Tzu Chi General Hospital
- Brief Summary
To investigate the prospective association between a vegetarian diet and chronic degenerative diseases in two cohorts of Taiwanese Buddhists
- Detailed Description
The Tzu Chi Vegetarian Study (TCVS) recruited 12062 community volunteers of the Buddhists Tzu Chi Foundation throughout Taiwan in the year 2005. All participants completed a self-administered questionnaire on basic information, medical history, lifestyle, and diet.
The Tzu Chi Health Study (TCHS) recruited 6002 participants who came to the Buddhist Tzu Chi Dalin General Hospital for health examination. All participants were interviewed on basic information, medical history, lifestyle, and diet. Biochemical and anthropometric data was collected through a health examination:
Biochemical variables: CBC, fasting glucose, lipid profile (TCH, LDL, HDL, TG), BUN, Cr, ALT, AST, and UA. In addition, homocysteine, serum vitamin B12, folate, and C-reactive protein (CRP) are available for 1500 subjects.
Blood: Extra blood samples have been obtained and stored for 3500 subjects and will be available for future investigation.
Anthropometric variables: body weight, height, waist circumference, % body fat (with BIA), blood pressure, pulse wave velocity, bone mineral density through DXA (at spine for female and hip for male), lung function test (spirometric), abdominal sonography, colonoscopy, esophageal-gastro-duodenal-scopy, chest X-ray, KUB.
Follow-up: Individual baseline data were linked to the National Health Insurance Database and the National Death Registry to ascertain disease outcomes at the Health and Welfare Data Science Center.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 18064
- Participants who consent to be followed.
- Participants with inaccurate ID which make linkage to NHIRD impossible.
- Participants already with study outcome (disease) prior to enrollment in the study.
- Participants with missing covariates
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tzu Chi Vegetarian Study Diet Exposure 12062 Tzu Chi volunteers of the Buddhist Tzu Chi Foundation recruited throughout communities in Taiwan in the year 2005. All participants filled out a self-administered questionnaire on basic information, medical history, lifestyle, and diet. Diet exposure: 1/3 vegetarians, 2/3 nonvegetarians. Tzu Chi Health Study Diet Exposure 6002 participants who came for health examination at the Dalin Tzu Chi Hospital between the years 2007 to 2009. 77% were Tzu Chi volunteers. All participants were interviewed on a structured questionnaire including basic information, medical history, lifestyle, and diet, and received a comprehensive health examination. Diet exposure: 1/3 vegetarians, 2/3 nonvegetarians.
- Primary Outcome Measures
Name Time Method Stroke From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014). Incidence of stroke are ascertained by linking individual participants' baseline data to the the National Health Insurance Database. Cases of stroke are identified using ICD-9 code: 430-438, where hemorrhagic stroke is defined by ICD9 430-432 and ischemic stroke is defined by ICD9 433-434.
Gout From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014). Incidence of gout are ascertained by linking individual participants' baseline data to the the National Health Insurance Database. Cases of gout are identified using ICD-9 code: 274.
Cataract From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014). Incidence of cataract are ascertained by linking individual participants' baseline data to the the National Health Insurance Database. Cases of cataract are identified using ICD-9 code: 366.
Urinary tract infections (UTI) From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014). Incidence of UTI are ascertained by linking individual participants' baseline data to the the National Health Insurance Database. Cases of UTI are identified using ICD-9 code: 599.0, 595, 590.
Gallstone disease From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014). Incidence of gallstone disease are ascertained by linking individual participants' baseline data to the the National Health Insurance Database. Cases of gallstone diseases are identified using ICD-9 code: 574.
Dementia and mild cognitive impairment From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014). Incidence of dementia are ascertained by linking individual participants' baseline data to the the National Health Insurance Database. Cases of dementia and mild cognitive impairment are identified using ICD-9 code: 290.0, 290.1,290.4, 331.0, 331.1, 331.82, 331.83.
Depression From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014). Incidence of depression are ascertained by linking individual participants' baseline data to the the National Health Insurance Database. Cases of depression and are identified using ICD-9 code: 296.2, 296.3, 300.4 and 311.
Medical expenditures From enrollment to December 31st 2014. Actual medical expenditure associated with different dietary patterns are analyzed. Medical expenditures are obtained and computed from the National Health Insurance Database claim data for outpatient treatment, inpatient treatment, and dental treatment. This also includes costs associated with laboratory work and medication prescription.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dalin Tzu Chi Hospital
🇨🇳Chiayi City, Taiwan