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Clinical Trials/NCT05092087
NCT05092087
Completed
Not Applicable

Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases

Taipei Medical University1 site in 1 country129 target enrollmentApril 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebrovascular Disease
Sponsor
Taipei Medical University
Enrollment
129
Locations
1
Primary Endpoint
The concentration of blood insulin
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 21, 2021
End Date
May 31, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

  • Mental problem
  • unable to do the measurement of body composition
  • incomplete the nutritional counseling program

Outcomes

Primary Outcomes

The concentration of blood insulin

Time Frame: within one week after the intervention

blood insulin in mg/dL

body mass index

Time Frame: immediately after the intervention

body mass index in kg/m\^2

The concentration of blood urinary nitrogen (BUN)

Time Frame: within one week after the intervention

BUN in mg/L

The concentration of blood globulin

Time Frame: within one week after the intervention

blood uric acid in mg/dL

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

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

The concentration of blood total cholesterol

Time Frame: within one week after the intervention

blood total cholesterol in mg/dL

blood HbA1C

Time Frame: within one week after the intervention

blood HbA1C in percentage

The concentration of blood total protein

Time Frame: within one week after the intervention

blood uric acid in mg/dL

height

Time Frame: immediately after the intervention

height in meters

The concentration of blood triglyceride

Time Frame: baseline, pre-intervention

blood triglyceride in mg/dL

The activity of blood alanine aminotransferase

Time Frame: within one week after the intervention

blood alanine aminotransferase in U/L

body weight

Time Frame: immediately after the intervention

body weight in kilograms

body fat

Time Frame: immediately after the intervention

body fat in ratio

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

The concentration of blood fasting glucose

Time Frame: within one week after the intervention

blood fasting glucose in mg/dL

The activity of blood aspartate aminotransferase

Time Frame: within one week after the intervention

blood aspartate aminotransferase in U/L

The concentration of blood creatinine

Time Frame: within one week after the intervention

BUN in mg/dL

The concentration of blood uric acid

Time Frame: within one week after the intervention

blood uric acid in mg/dL

The concentration of blood albumin

Time Frame: within one week after the intervention

blood uric acid in mg/dL

Study Sites (1)

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