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DiabetesTCHSNCT03204552

Tzu Chi Health Study (Diabetes and Cardiometabolic Health Components)

An observational study of Diabetes and Fatty Liver, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes, Fatty Liver, Cardiometabolic Health
How many people
6,002 participants
Where
1 siteTaiwan
Study dates
15 Oct 2007to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: More than 70% of the participants are Tzu Chi Commissioners. The female-to-male ratio is about 2:1, and about one-third of study participants were vegetarians.

Who may be able to join

  • Adult individuals who came to Dalin Tzu Chi Hospital for health examination between 2007 to 2009.
  • 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

Who cannot join

  • Participants less than 18 years old.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Dalin Tzu Chi Hospital

    Chiayi City

Other trials in Taiwan

About this study

Official title: Dalin Tzu Chi General Hospital

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

Read the detailed description

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.

How are the study subjects followed up? Participants are followed through several methods: (1) every three years, participants were invited back for detailed health examination. (2) Follow-up questionnaire sent to participants who did not return for health examination. (3) Linkages to the National Health Insurance Database and death registry.

What has been measured? Dietary, lifestyle and medical and family histories on diseases were obtained through a questionnaire, administered by interviewers. Biochemical and anthropometric data was collected through physical exams.

  • Dietary questionnaire: A dietary questionnaire has been administered, with trained research dietitians as interviewers. The questionnaire was adopted from the National Nutrition Survey in Taiwan.
  • 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.
Being tested
No intervention (observational study)
Medical subject headings
Diabetes Mellitus, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention (observational study)Other

    No intervention (observational study)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes

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

    Measured: 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

  2. Fatty liver

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

    Measured: 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

  3. Change in cardiometabolic health markers

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

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

  4. Change in BMI

    Change in BMI (calculated through height and weigh)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2017
  2. Study start15 Oct 2007
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03204552
Sponsor's protocol ID
TCHS-01
Acronym
TCHS
Status last verified
Jul 2018
First submitted
21 Jun 2017
Last updated
26 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chiu TH, Huang HY, Chen KJ, Wu YR, Chiu JP, Li YH, Chiu BC, Lin CL, Lin MN. Relative validity and reproducibility of a quantitative FFQ for assessing nutrient intakes of vegetarians in Taiwan. Public Health Nutr. 2014 Jul;17(7):1459-66. doi: 10.1017/S1368980013001560. Epub 2013 Jun 20.

    PubMed 23782894

  • Chiu TH, Huang HY, Chiu YF, Pan WH, Kao HY, Chiu JP, Lin MN, Lin CL. Taiwanese vegetarians and omnivores: dietary composition, prevalence of diabetes and IFG. PLoS One. 2014 Feb 11;9(2):e88547. doi: 10.1371/journal.pone.0088547. eCollection 2014.

    PubMed 24523914

  • Chiu THT, Pan WH, Lin MN, Lin CL. Vegetarian diet, change in dietary patterns, and diabetes risk: a prospective study. Nutr Diabetes. 2018 Mar 9;8(1):12. doi: 10.1038/s41387-018-0022-4.

    PubMed 29549240

  • Chiu TH, Lin MN, Pan WH, Chen YC, Lin CL. Vegetarian diet, food substitution, and nonalcoholic fatty liver. Tzu Chi Med J. 2018 Apr-Jun;30(2):102-109. doi: 10.4103/tcmj.tcmj_109_17.

    PubMed 29875591

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes and Fatty Liver, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03204552, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.

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