Clinical trial NCT05092087: Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases
Official title: Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Disease
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 129
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who volunteer to pay and completed nutrition consultations from Bon-Vivant Health Lifestyle Management Center.

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.

Eligibility criteria: 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

Primary outcomes:
measure: body weight
timeFrame: baseline, pre-intervention
measure: body weight
timeFrame: immediately after the intervention
measure: height
timeFrame: baseline, pre-intervention
measure: height
timeFrame: immediately after the intervention
measure: body mass index
timeFrame: baseline, pre-intervention
measure: body mass index
timeFrame: immediately after the intervention
measure: body fat
timeFrame: baseline, pre-intervention
measure: body fat
timeFrame: immediately after the intervention
measure: The concentration of blood triglyceride
timeFrame: baseline, pre-intervention
measure: The concentration of blood total cholesterol
timeFrame: within one week after the intervention
measure: The concentration of blood low density lipoprotein-cholesterol
timeFrame: baseline, pre-intervention
measure: The concentration of blood low density lipoprotein-cholesterol
timeFrame: within one week after the intervention
measure: The concentration of blood high density lipoprotein-cholesterol-cholesterol
timeFrame: baseline, pre-intervention
measure: The concentration of blood high density lipoprotein-cholesterol-cholesterol
timeFrame: within one week after the intervention
measure: The concentration of blood high sensitive C-reactive protein
timeFrame: baseline, pre-intervention
measure: The concentration of blood high sensitive C-reactive protein
timeFrame: within one week after the intervention
measure: The concentration of blood fasting glucose
timeFrame: baseline, pre-intervention
measure: The concentration of blood fasting glucose
timeFrame: within one week after the intervention
measure: blood HbA1C
timeFrame: baseline, pre-intervention
measure: blood HbA1C
timeFrame: within one week after the intervention
measure: The concentration of blood insulin
timeFrame: baseline, pre-intervention
measure: The concentration of blood insulin
timeFrame: within one week after the intervention
measure: The activity of blood aspartate aminotransferase
timeFrame: baseline, pre-intervention
measure: The activity of blood aspartate aminotransferase
timeFrame: within one week after the intervention
measure: The activity of blood alanine aminotransferase
timeFrame: baseline, pre-intervention
measure: The activity of blood alanine aminotransferase
timeFrame: within one week after the intervention
measure: The concentration of blood urinary nitrogen (BUN)
timeFrame: baseline, pre-intervention
measure: The concentration of blood urinary nitrogen (BUN)
timeFrame: within one week after the intervention
measure: The concentration of blood creatinine
timeFrame: baseline, pre-intervention
measure: The concentration of blood creatinine
timeFrame: within one week after the intervention
measure: The concentration of blood uric acid
timeFrame: baseline, pre-intervention
measure: The concentration of blood uric acid
timeFrame: within one week after the intervention
measure: The concentration of blood total protein
timeFrame: baseline, pre-intervention
measure: The concentration of blood total protein
timeFrame: within one week after the intervention
measure: The concentration of blood albumin
timeFrame: baseline, pre-intervention
measure: The concentration of blood albumin
timeFrame: within one week after the intervention
measure: The concentration of blood globulin
timeFrame: baseline, pre-intervention
measure: The concentration of blood globulin
timeFrame: within one week after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Suh-Ching Yang
role: STUDY_CHAIR
References: