Dietary Intervention for Cardiovascular Disease

October 25, 2023 updated by: Wen-Harn Pan, Academia Sinica, Taiwan
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Beitou District
      • Taipei, Beitou District, Taiwan, 112
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: usual medical management
with regular doctor visits every 3 months
Other: control:usual medical management
with regular doctor visits every 3 months
Experimental: 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
Other: control:usual medical management
with regular doctor visits every 3 months
Behavioral: intervention 1:usual medical management+individual dieting consultation
with regular doctor visits every 3 months and dietitian visits every 3 months
Experimental: 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
Other: control:usual medical management
with regular doctor visits every 3 months
Behavioral: intervention 1:usual medical management+individual dieting consultation
with regular doctor visits every 3 months and dietitian visits every 3 months
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in diet quality at Year 1, 2, and 3.
Time Frame: 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
Baseline, year 1, 2 and 3
Change from baseline in concentrations of cardiovascular risk factors at Month 6, 12, 18, 24,30, and 36.
Time Frame: 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.
Baseline and Month 6, 12, 18, 24, 30, and 36.
Events of cardiovascular diseases at Year 6.
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the dosage of prescribed drugs at Month 6, 12, 18, 24,30, and 36.
Time Frame: Baseline and Month 6, 12, 18, 24, 30, and 36.
Prescribed drugs for cardiovascular diseases.
Baseline and Month 6, 12, 18, 24, 30, and 36.
Change from baseline in cardiovascular risk score
Time Frame: 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.
Baseline, year 1, 2 and 3.
Change from baseline in concentrations of inflammatory markers at Year 1, 2, and 3.
Time Frame: Baseline, year 1, 2 and 3.
Inflammatory markers include IL-1β, IL-6, IL-8, IL-10，TNF- α, IFN-γ in blood.
Baseline, year 1, 2 and 3.
Change from baseline in scores of Montreal Cognitive Assessment at Year 1, 2, and 3.
Time Frame: 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.
Baseline, year 1, 2 and 3.
Change from baseline in scores of Number Cancellation test
Time Frame: 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.
Baseline, year 1, 2 and 3.
Change from baseline in the number of digits at Year 1, 2 and 3.
Time Frame: 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.
Baseline, year 1, 2 and 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academia Sinica, Taiwan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wen-Harn Pan, Ph.D, Institute of Biomedical Sciences, Academia Sinica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AS-IRB-BM-19057

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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