Study Stopped
Due to the severe epidemic situation of COVID-19 and the shortage of research funds and manpower for research projects, the study was halted prematurely.
Dietary Intervention for Cardiovascular Disease
1 other identifier
interventional
40
1 country
1
Brief Summary
Incidence of cardiometabolic disease (CMD) continues to rise, which consumes huge medical resources in Taiwan. The effectiveness of dietary therapy for CMD has not been locally evaluated in detail. CVD is an important risk factor for dementia. At the present time, there is no effective treatment available for dementia. Early prevention is extremely important. Our previous studies have shown that Taiwanese dementia protective diet is very similar to cardiovascular prevention and control diet, meaning that effective dietary therapy may not only control CVD but also prevent dementia development. Therefore, this study intends to document the effects of dietary intervention on cardiovascular disease risk factor control, the long-term outcomes on the occurrence of cardiovascular events, and the maintenance of cognitive function for patients with coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Dec 2021
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2021
CompletedStudy Start
First participant enrolled
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2023
CompletedOctober 27, 2023
October 1, 2023
1.1 years
December 19, 2021
October 25, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Change from baseline in diet quality at Year 1, 2, and 3.
Diet quality is estimated according to the daily intake of nutrients and the distribution of the six food groups, with a qualified food frequency questionnaire. The six food groups include: 1. Whole grains and starchy vegetables 2. Protein foods: soybeans, fish, eggs, and meat 3. Vegetables 4. Fruits 5. Dairy 6. Oils, nuts \& seeds
Baseline, year 1, 2 and 3
Change from baseline in concentrations of cardiovascular risk factors at Month 6, 12, 18, 24,30, and 36.
Cardiovascular risk factors include total cholesterol,triglyceride, low-density lipoprotein ,high-density lipoprotein, uric acid, glucose, HbA1C.
Baseline and Month 6, 12, 18, 24, 30, and 36.
Events of cardiovascular diseases at Year 6.
CVD or non-CVD death, stroke, acute myocardial infarction, hospitalization for acute coronary syndrome, hospitalization for coronary intervention surgery, hospitalization for various cardiovascular diseases, hospitalization for heart failure, hospitalization for other CVD diseases, new-onset heart arrhythmia, new-onset peripheral blood vessels block
Year 6.
Secondary Outcomes (6)
Change from baseline in the dosage of prescribed drugs at Month 6, 12, 18, 24,30, and 36.
Baseline and Month 6, 12, 18, 24, 30, and 36.
Change from baseline in cardiovascular risk score
Baseline, year 1, 2 and 3.
Change from baseline in concentrations of inflammatory markers at Year 1, 2, and 3.
Baseline, year 1, 2 and 3.
Change from baseline in scores of Montreal Cognitive Assessment at Year 1, 2, and 3.
Baseline, year 1, 2 and 3.
Change from baseline in scores of Number Cancellation test
Baseline, year 1, 2 and 3.
- +1 more secondary outcomes
Study Arms (3)
usual medical management
PLACEBO COMPARATORwith regular doctor visits every 3 months
usual medical management+individual dietary consultation
EXPERIMENTALwith regular doctor visits every 3 months and dietitian visits every 3 months until meeting dietary recommendation or reaching 3 years limit
usual medical management+individual dietary consultation+ daily tea drinking
EXPERIMENTALwith regular doctor visits every 3 months, dietitian visits every 3 months until meeting dietary recommendation or reaching 3 years limit, and daily tea drinking
Interventions
with regular doctor visits every 3 months
with regular doctor visits every 3 months and dietitian visits every 3 months
with regular doctor visits every 3 months and dietitian visits every 3 months and daily tea drinking
Eligibility Criteria
You may qualify if:
- Have received percutaneous transluminal coronary artery surgery.
- Stable drug control for more than one month
You may not qualify if:
- Suffer from cancer and undergo chemotherapy or surgery within one year.
- Those who have a major illness in hospital within one year.
- Those with kidney disease stage 5 (inclusive) or above
- Those whose life expectancy does not exceed half a year
- Patients with diagnosed dementia
- Those who do not want to be tracked
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Academia Sinica, Taiwanlead
- Taipei Veterans General Hospital, Taiwancollaborator
Study Sites (1)
Taipei Veterans General Hospital
Taipei, Beitou District, 112, Taiwan
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Wen-Harn Pan, Ph.D
Institute of Biomedical Sciences, Academia Sinica
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Research Fellow, Principal Investigator
Study Record Dates
First Submitted
December 19, 2021
First Posted
January 21, 2022
Study Start
December 23, 2021
Primary Completion
February 14, 2023
Study Completion
February 14, 2023
Last Updated
October 27, 2023
Record last verified: 2023-10