Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases

Completed

• Conditions: Cerebrovascular Disease
• Interventions: Behavioral: nutrition counseling

• Registration Number: NCT05092087
• Lead Sponsor: Taipei Medical University

Brief Summary

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.

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 Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-21
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-10-11
• Last Update Submitted: 2021-10-11
• Study First Posted: 2021-10-25
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
test group/ regularity group	nutrition counseling	those who completed the consultations and interval time within in 3 weeks were in the higher regularity
Control group/ non-regularity group	nutrition counseling	those who completed 8 consultations by average interval time more than 3 weeks were in the non-regularity group

Primary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan