Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases

Cerebrovascular Disease Clinical Trial

Official title:

Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05092087
• Other study ID #: N202103134
• Status: Completed
• Start date: April 21, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2021
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Disease
• Cerebrovascular Disorders

Intervention

Behavioral:
• nutrition counseling
nutrition counseling

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

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