Dietary Intervention for Cardiovascular Disease

NCT ID: NCT05201898

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-23

Study Completion Date

2023-02-14

Brief Summary

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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

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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usual medical management

with regular doctor visits every 3 months

Group Type PLACEBO_COMPARATOR

control:usual medical management

Intervention Type OTHER

with regular doctor visits every 3 months

usual medical management+individual dietary consultation

with regular doctor visits every 3 months and dietitian visits every 3 months until meeting dietary recommendation or reaching 3 years limit

Group Type EXPERIMENTAL

control:usual medical management

Intervention Type OTHER

with regular doctor visits every 3 months

intervention 1:usual medical management+individual dieting consultation

Intervention Type BEHAVIORAL

with regular doctor visits every 3 months and dietitian visits every 3 months

usual medical management+individual dietary consultation+ daily tea drinking

with regular doctor visits every 3 months, dietitian visits every 3 months until meeting dietary recommendation or reaching 3 years limit, and daily tea drinking

Group Type EXPERIMENTAL

control:usual medical management

Intervention Type OTHER

with regular doctor visits every 3 months

intervention 1:usual medical management+individual dieting consultation

Intervention Type BEHAVIORAL

with regular doctor visits every 3 months and dietitian visits every 3 months

intervention 2:usual medical management+individual dieting consultation+ daily tea drinking

Intervention Type BEHAVIORAL

with regular doctor visits every 3 months and dietitian visits every 3 months and daily tea drinking

Interventions

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control:usual medical management

with regular doctor visits every 3 months

Intervention Type OTHER

intervention 1:usual medical management+individual dieting consultation

with regular doctor visits every 3 months and dietitian visits every 3 months

Intervention Type BEHAVIORAL

intervention 2:usual medical management+individual dieting consultation+ daily tea drinking

with regular doctor visits every 3 months and dietitian visits every 3 months and daily tea drinking

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

Academia Sinica, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Wen-Harn Pan

Distinguished Research Fellow, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wen-Harn Pan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Institute of Biomedical Sciences, Academia Sinica

Locations

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Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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AS-IRB-BM-19057

Identifier Type: -

Identifier Source: org_study_id

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