Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases

October 11, 2021 updated by: Taipei Medical University
This study aims to investigate the frequency of personalized nutrition counseling's effect on individual cardiovascular risk factors. The study collected 110 to 150 cases data, including a regular blood test, blood glucose, blood lipid, liver panel, and inflammatory factors. The enrolled cases were classified into two groups according to the subjects' duration of consultation: those who completed the consultation and subsequent tests in >24 weeks were in the control group, whereas those who completed the consultation and subsequent tests in <24 weeks were in the test group. The effectiveness of nutrition consultation toward managing cardiovascular disease risk factors and its correlation with the subjects' frequency of following the consultations was analyzed using the pre- and post-consultation data. It was found that personalized nutrition consultation significantly improved the subjects' risk factors of cardiovascular diseases, and that the treatment group showed a greater improvement than the control group which who require over 24 weeks to complete all consultation sessions.

Study Overview

Status

Status

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

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.

Detailed Description

The most of interventional studies on nutrition consultation have generally emphasized on the extent to which the diet composition can prevent chronic diseases or provide improvement. Although dietitians play an important role in health education for the primary prevention of chronic disease, their individuals dietary consultation results are mostly focused on weight loss and blood glucose control. However, the effectiveness of nutrition consultation on the prevention of chronic diseases, such as hyperlipidemia, hypertension and cardiovascular diseases, has few been studied. The effectiveness of dietary instructions provided to individuals by dietitians in primary health care institutes is yet to be validated with significant evidence. In addition, nutrition consultation methods, processes, and influencing factors on its results are seldom discussed. Therefore, this study aims to investigate the frequency of personalized nutrition counseling's effect on individual cardiovascular risk factors. The study collected1 10 to 150 cases data who aimed to prevent or improve chronic diseases and had completed eight times individualized nutrition consultations from Bon Vivant Health Lifestyle Management Center, and the pre- and post-consultation data, including a regular blood test, blood glucose, blood lipid, liver panel, and inflammatory factors, will be analyzed. Blood were drawn before and after the first and the last time consultation for biochemical tests; blood pressure and body composition was also measured for comparison. The enrolled cases will be classified into two groups according to the subjects' duration of consultation: those who completed the consultation and subsequent tests in >24 weeks were in the control group, whereas those who completed the consultation and subsequent tests in <24 weeks were in the test group. The effectiveness of nutrition consultation toward managing cardiovascular disease risk factors and its correlation with the subjects' frequency of following the consultations was analyzed using the pre- and post-consultation data. It was found that personalized nutrition consultation significantly improved the subjects' risk factors of cardiovascular diseases, and that the treatment group showed a greater improvement than the control group which who require over 24 weeks to complete all consultation sessions.

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.
Observational

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.
129

Contacts and Locations

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

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Taipei Medical University

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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People who volunteer to pay and completed nutrition consultations from Bon-Vivant Health Lifestyle Management Center.

Description

Inclusion Criteria:

  • Age ≧ 20
  • Anyone of follow： body mass index > 24 systolic blood pressure > 120 mmHg diastolic blood pressure > 80 mmHg triglyceride > 150 mg/dL fasting blood glucose >100 mg/dL

Exclusion Criteria:

  • Age <20
  • pregnant
  • Mental problem
  • unable to do the measurement of body composition
  • incomplete the nutritional counseling program

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Control group/ non-regularity group
those who completed 8 consultations by average interval time more than 3 weeks were in the non-regularity group
Behavioral: nutrition counseling
nutrition counseling
test group/ regularity group
those who completed the consultations and interval time within in 3 weeks were in the higher regularity
Behavioral: nutrition counseling
nutrition counseling

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
body weight
Time Frame: baseline, pre-intervention
body weight in kilograms
baseline, pre-intervention
body weight
Time Frame: immediately after the intervention
body weight in kilograms
immediately after the intervention
height
Time Frame: baseline, pre-intervention
height in meters
baseline, pre-intervention
height
Time Frame: immediately after the intervention
height in meters
immediately after the intervention
body mass index
Time Frame: baseline, pre-intervention
body mass index in kg/m^2
baseline, pre-intervention
body mass index
Time Frame: immediately after the intervention
body mass index in kg/m^2
immediately after the intervention
body fat
Time Frame: baseline, pre-intervention
body fat in ratio
baseline, pre-intervention
body fat
Time Frame: immediately after the intervention
body fat in ratio
immediately after the intervention
The concentration of blood triglyceride
Time Frame: baseline, pre-intervention
blood triglyceride in mg/dL
baseline, pre-intervention
The concentration of blood total cholesterol
Time Frame: within one week after the intervention
blood total cholesterol in mg/dL
within one week after the intervention
The concentration of blood low density lipoprotein-cholesterol
Time Frame: baseline, pre-intervention
blood blood low density lipoprotein-cholesterol in mg/dL
baseline, pre-intervention
The concentration of blood low density lipoprotein-cholesterol
Time Frame: within one week after the intervention
blood blood low density lipoprotein-cholesterol in mg/dL
within one week after the intervention
The concentration of blood high density lipoprotein-cholesterol-cholesterol
Time Frame: baseline, pre-intervention
blood high density lipoprotein-cholesterol in mg/dL
baseline, pre-intervention
The concentration of blood high density lipoprotein-cholesterol-cholesterol
Time Frame: within one week after the intervention
blood high density lipoprotein-cholesterol in mg/dL
within one week after the intervention
The concentration of blood high sensitive C-reactive protein
Time Frame: baseline, pre-intervention
blood high sensitive sensitive C-reactive protein in mg/L
baseline, pre-intervention
The concentration of blood high sensitive C-reactive protein
Time Frame: within one week after the intervention
blood high sensitive sensitive C-reactive protein in mg/L
within one week after the intervention
The concentration of blood fasting glucose
Time Frame: baseline, pre-intervention
blood fasting glucose in mg/dL
baseline, pre-intervention
The concentration of blood fasting glucose
Time Frame: within one week after the intervention
blood fasting glucose in mg/dL
within one week after the intervention
blood HbA1C
Time Frame: baseline, pre-intervention
blood HbA1C in percentage
baseline, pre-intervention
blood HbA1C
Time Frame: within one week after the intervention
blood HbA1C in percentage
within one week after the intervention
The concentration of blood insulin
Time Frame: baseline, pre-intervention
blood insulin in mg/dL
baseline, pre-intervention
The concentration of blood insulin
Time Frame: within one week after the intervention
blood insulin in mg/dL
within one week after the intervention
The activity of blood aspartate aminotransferase
Time Frame: baseline, pre-intervention
blood aspartate aminotransferase in U/L
baseline, pre-intervention
The activity of blood aspartate aminotransferase
Time Frame: within one week after the intervention
blood aspartate aminotransferase in U/L
within one week after the intervention
The activity of blood alanine aminotransferase
Time Frame: baseline, pre-intervention
blood alanine aminotransferase in U/L
baseline, pre-intervention
The activity of blood alanine aminotransferase
Time Frame: within one week after the intervention
blood alanine aminotransferase in U/L
within one week after the intervention
The concentration of blood urinary nitrogen (BUN)
Time Frame: baseline, pre-intervention
BUN in mg/L
baseline, pre-intervention
The concentration of blood urinary nitrogen (BUN)
Time Frame: within one week after the intervention
BUN in mg/L
within one week after the intervention
The concentration of blood creatinine
Time Frame: baseline, pre-intervention
BUN in mg/dL
baseline, pre-intervention
The concentration of blood creatinine
Time Frame: within one week after the intervention
BUN in mg/dL
within one week after the intervention
The concentration of blood uric acid
Time Frame: baseline, pre-intervention
blood uric acid in mg/dL
baseline, pre-intervention
The concentration of blood uric acid
Time Frame: within one week after the intervention
blood uric acid in mg/dL
within one week after the intervention
The concentration of blood total protein
Time Frame: baseline, pre-intervention
blood uric acid in mg/dL
baseline, pre-intervention
The concentration of blood total protein
Time Frame: within one week after the intervention
blood uric acid in mg/dL
within one week after the intervention
The concentration of blood albumin
Time Frame: baseline, pre-intervention
blood uric acid in mg/dL
baseline, pre-intervention
The concentration of blood albumin
Time Frame: within one week after the intervention
blood uric acid in mg/dL
within one week after the intervention
The concentration of blood globulin
Time Frame: baseline, pre-intervention
blood uric acid in mg/dL
baseline, pre-intervention
The concentration of blood globulin
Time Frame: within one week after the intervention
blood uric acid in mg/dL
within one week after the intervention

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.
Taipei Medical University

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.
  • Study Chair: Suh-Ching Yang, Taipei Medical University

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.
April 21, 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.
May 31, 2021

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.
May 31, 2021

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).
September 1, 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.
October 11, 2021

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.
October 25, 2021

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 25, 2021

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 11, 2021

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.
April 1, 2021

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.
  • N202103134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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