Clinical trial NCT05201898: Dietary Intervention for Cardiovascular Disease
Official title: Dietary Intervention for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2022-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Have received percutaneous transluminal coronary artery surgery.
2. Stable drug control for more than one month

Exclusion Criteria:

1. Suffer from cancer and undergo chemotherapy or surgery within one year.
2. Those who have a major illness in hospital within one year.
3. Those with kidney disease stage 5 (inclusive) or above
4. Those whose life expectancy does not exceed half a year
5. Patients with diagnosed dementia
6. Those who do not want to be tracked

Primary outcomes:
measure: Change from baseline in diet quality at Year 1, 2, and 3.
timeFrame: Baseline, year 1, 2 and 3
measure: Change from baseline in concentrations of cardiovascular risk factors at Month 6, 12, 18, 24,30, and 36.
timeFrame: Baseline and Month 6, 12, 18, 24, 30, and 36.
measure: Events of cardiovascular diseases at Year 6.
timeFrame: Year 6.
Secondary outcomes:
measure: Change from baseline in the dosage of prescribed drugs at Month 6, 12, 18, 24,30, and 36.
timeFrame: Baseline and Month 6, 12, 18, 24, 30, and 36.
measure: Change from baseline in cardiovascular risk score
timeFrame: Baseline, year 1, 2 and 3.
measure: Change from baseline in concentrations of inflammatory markers at Year 1, 2, and 3.
timeFrame: Baseline, year 1, 2 and 3.
measure: Change from baseline in scores of Montreal Cognitive Assessment at Year 1, 2, and 3.
timeFrame: Baseline, year 1, 2 and 3.
measure: Change from baseline in scores of Number Cancellation test
timeFrame: Baseline, year 1, 2 and 3.
measure: Change from baseline in the number of digits at Year 1, 2 and 3.
timeFrame: Baseline, year 1, 2 and 3.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
Study officials:
affiliation: Institute of Biomedical Sciences, Academia Sinica
name: Wen-Harn Pan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: