Dietary Intervention for Cardiovascular Disease

Not Applicable

Terminated

• Conditions: Cardiovascular Diseases

• Registration Number: NCT05201898
• Lead Sponsor: Academia Sinica, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-19
• Study Start: 2021-12-23
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-21
• Primary Completion: 2023-02-14
• Study Completion: 2023-02-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Events of cardiovascular diseases at Year 6.	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
Change from baseline in diet quality at Year 1, 2, and 3.	Baseline, 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
Change from baseline in concentrations of cardiovascular risk factors at Month 6, 12, 18, 24,30, and 36.	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the number of digits at Year 1, 2 and 3.	Baseline, year 1, 2 and 3.	A digit span task is used to measure working memory's number storage capacity. Subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). The score is the length of the longest correctly repeated sequence. The maximum number of digits in a sequence is 9 and the minimum number of digits in a sequence is 2. The higher scores mean a better outcome.
Change from baseline in scores of Montreal Cognitive Assessment at Year 1, 2, and 3.	Baseline, year 1, 2 and 3.	Scores on the Montreal Cognitive Assessment range from zero to 30. A score of 26 and higher is considered normal.
Change from baseline in scores of Number Cancellation test	Baseline, year 1, 2 and 3.	A sub-scale of Alzheimer's Disease Assessment Scale. Cancellation score = number of targets hit in 45 seconds - (minus) number of errors - (minus) number of times reminded of the task.
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.	Prescribed drugs for cardiovascular diseases.
Change from baseline in cardiovascular risk score	Baseline, year 1, 2 and 3.	Taiwanese edition of Framingham Risk Score, a 10-year risk score derived as a percentage. Risk is considered low if the Framingham Risk Score is less than 10%, moderate if it is 10% to 19%, and high if it is 20% or higher.
Change from baseline in concentrations of inflammatory markers at Year 1, 2, and 3.	Baseline, year 1, 2 and 3.	Inflammatory markers include IL-1β, IL-6, IL-8, IL-10，TNF- α, IFN-γ in blood.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Beitou District, Taiwan