Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vegetarian Diet and Chronic Degenerative Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470584
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital

Tracking Information
First Submitted Date March 12, 2018
First Posted Date March 20, 2018
Last Update Posted Date March 20, 2018
Actual Study Start Date March 1, 2005
Actual Primary Completion Date December 30, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2018)
  • Gout [ Time Frame: 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.
  • Stroke [ Time Frame: 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.
  • Cataract [ Time Frame: 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.
  • Gallstone disease [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Urinary tract infections (UTI) [ Time Frame: 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.
  • Medical expenditures [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vegetarian Diet and Chronic Degenerative Diseases
Official Title Vegetarian Diet and Chronic Degenerative Diseases in the Tzu Chi Health Study (TCHS) and the Tzu Chi Vegetarian Study (TCVS)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum samples for 3500 participants from the Tzu Chi Health Study
Sampling Method Non-Probability Sample
Study Population Participants in the Tzu Chi Vegetarian Study were all certified volunteers of the Buddhist Tzu Chi Foundation. Participants of the Tzu Chi Health Study were the ones who came to the Dalin Tzu Chi Hospital for health examination and agree to join the cohort study (77% were certified Tzu Chi volunteers). About 1/3 of both cohorts were vegetarians at enrollment.
Condition
  • Dementia
  • Depression
  • Cardiovascular Diseases
  • Stroke
  • Gout
  • Cataract
  • Gallstone
  • Urinary Tract Infections
Intervention Other: Diet Exposure
Vegetarian diet vs nonvegetarian diet
Study Groups/Cohorts
  • Tzu Chi Vegetarian Study
    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.
    Intervention: Other: Diet Exposure
  • Tzu Chi Health Study
    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.
    Intervention: Other: Diet Exposure
Publications * Chiu THT, Liu CH, Chang CC, Lin MN, Lin CL. Vegetarian diet and risk of gout in two separate prospective cohort studies. Clin Nutr. 2020 Mar;39(3):837-844. doi: 10.1016/j.clnu.2019.03.016. Epub 2019 Mar 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 18, 2018)
18064
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2014
Actual Primary Completion Date December 30, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender Not Provided
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03470584
Other Study ID Numbers TCHS-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The disease outcome data from the National Health Insurance Database belongs to the Ministry of Health in Taiwan. Access to these data requires permission and formal application to the Health and Welfare Data Science Center, Ministry of Health in Taiwan. This is regulated by local law and regulation to protect individual personal information. Our research team does not have the right to release any data other than summarized results in the forms of peer-reviewed publications, for noncommercial purposes.
Responsible Party Dalin Tzu Chi General Hospital
Study Sponsor Dalin Tzu Chi General Hospital
Collaborators Not Provided
Investigators
Study Chair: Chin-Lon Lin, MD Dalin Tzu Chi General Hospital
PRS Account Dalin Tzu Chi General Hospital
Verification Date March 2018