Clinical trial NCT03470584: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Depression
Cardiovascular Diseases
Stroke
Gout
Cataract
Gallstone
Urinary Tract Infections
Keywords: Diet, vegetarian
Dementia
Depression
Cardiovascular Diseases
Stroke
Gout
Cataract
Gallstone
Urinary Tract Infections
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 18064
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Gout
timeFrame: From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
measure: Stroke
timeFrame: From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
measure: Cataract
timeFrame: From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
measure: Gallstone disease
timeFrame: From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
measure: Dementia and mild cognitive impairment
timeFrame: From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
measure: Depression
timeFrame: From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
measure: Urinary tract infections (UTI)
timeFrame: From enrollment to time of disease occurrence, death of any cause, or end of study period (December 31st 2014).
measure: Medical expenditures
timeFrame: From enrollment to December 31st 2014.
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Dalin Tzu Chi Hospital
Study officials:
affiliation: Dalin Tzu Chi General Hospital
name: Chin-Lon Lin, MD
role: STUDY_CHAIR
References:
citation: 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.