Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases

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: Completed
• Conditions: Cerebrovascular Disease
• Intervention / Treatment: Behavioral: nutrition counseling

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: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 21, 2021
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (ACTUAL): October 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Cerebrovascular Disorders
• Other Study ID 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