Vegetarian Diet and Chronic Degenerative Diseases

Stroke Clinical Trial

Official title:

Vegetarian Diet and Chronic Degenerative Diseases in the Tzu Chi Health Study (TCHS) and the Tzu Chi Vegetarian Study (TCVS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470584
• Other study ID #: TCHS-02
• Status: Completed
• First received: March 12, 2018
• Last updated: March 18, 2018
• Start date: March 1, 2005
• Est. completion date: December 31, 2014

Study information

• Verified date: March 2018
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the prospective association between a vegetarian diet and chronic degenerative diseases in two cohorts of Taiwanese Buddhists

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 information / eligibility

• Status: Completed
• Enrollment: 18064
• Est. completion date: December 31, 2014
• Est. primary completion date: December 30, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants who consent to be followed.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cataract
• Cholecystolithiasis
• Cholelithiasis
• Dementia
• Depression
• Gallstone
• Gallstones
• Gout
• Stroke
• Urinary Tract Infections

Intervention

Other:
• Diet Exposure
Vegetarian diet vs nonvegetarian diet

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gout	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.	From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
Primary	Stroke	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.	From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
Primary	Cataract	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.	From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
Primary	Gallstone disease	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.	From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
Primary	Dementia and mild cognitive impairment	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.	From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
Primary	Depression	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.	From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
Primary	Urinary tract infections (UTI)	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.	From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
Primary	Medical expenditures	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.	From enrollment to December 31st 2014.