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NCT Number: NCT05092087

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.

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Key information

Conditions

Cerebrovascular Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Medical University

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition counseling

Behavioral

nutrition counseling

Primary outcomes

  1. body weight

    Time frame: baseline, pre-intervention

    body weight in kilograms

  2. body weight

    Time frame: immediately after the intervention

    body weight in kilograms

  3. height

    Time frame: baseline, pre-intervention

    height in meters

  4. height

    Time frame: immediately after the intervention

    height in meters

  5. body mass index

    Time frame: baseline, pre-intervention

    body mass index in kg/m^2

  6. body mass index

    Time frame: immediately after the intervention

    body mass index in kg/m^2

  7. body fat

    Time frame: baseline, pre-intervention

    body fat in ratio

  8. body fat

    Time frame: immediately after the intervention

    body fat in ratio

  9. The concentration of blood triglyceride

    Time frame: baseline, pre-intervention

    blood triglyceride in mg/dL

  10. The concentration of blood total cholesterol

    Time frame: within one week after the intervention

    blood total cholesterol in mg/dL

  11. The concentration of blood low density lipoprotein-cholesterol

    Time frame: baseline, pre-intervention

    blood blood low density lipoprotein-cholesterol in mg/dL

  12. 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

  13. The concentration of blood high density lipoprotein-cholesterol-cholesterol

    Time frame: baseline, pre-intervention

    blood high density lipoprotein-cholesterol in mg/dL

  14. 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

  15. The concentration of blood high sensitive C-reactive protein

    Time frame: baseline, pre-intervention

    blood high sensitive sensitive C-reactive protein in mg/L

  16. 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

  17. The concentration of blood fasting glucose

    Time frame: baseline, pre-intervention

    blood fasting glucose in mg/dL

  18. The concentration of blood fasting glucose

    Time frame: within one week after the intervention

    blood fasting glucose in mg/dL

  19. blood HbA1C

    Time frame: baseline, pre-intervention

    blood HbA1C in percentage

  20. blood HbA1C

    Time frame: within one week after the intervention

    blood HbA1C in percentage

  21. The concentration of blood insulin

    Time frame: baseline, pre-intervention

    blood insulin in mg/dL

  22. The concentration of blood insulin

    Time frame: within one week after the intervention

    blood insulin in mg/dL

  23. The activity of blood aspartate aminotransferase

    Time frame: baseline, pre-intervention

    blood aspartate aminotransferase in U/L

  24. The activity of blood aspartate aminotransferase

    Time frame: within one week after the intervention

    blood aspartate aminotransferase in U/L

  25. The activity of blood alanine aminotransferase

    Time frame: baseline, pre-intervention

    blood alanine aminotransferase in U/L

  26. The activity of blood alanine aminotransferase

    Time frame: within one week after the intervention

    blood alanine aminotransferase in U/L

  27. The concentration of blood urinary nitrogen (BUN)

    Time frame: baseline, pre-intervention

    BUN in mg/L

  28. The concentration of blood urinary nitrogen (BUN)

    Time frame: within one week after the intervention

    BUN in mg/L

  29. The concentration of blood creatinine

    Time frame: baseline, pre-intervention

    BUN in mg/dL

  30. The concentration of blood creatinine

    Time frame: within one week after the intervention

    BUN in mg/dL

  31. The concentration of blood uric acid

    Time frame: baseline, pre-intervention

    blood uric acid in mg/dL

  32. The concentration of blood uric acid

    Time frame: within one week after the intervention

    blood uric acid in mg/dL

  33. The concentration of blood total protein

    Time frame: baseline, pre-intervention

    blood uric acid in mg/dL

  34. The concentration of blood total protein

    Time frame: within one week after the intervention

    blood uric acid in mg/dL

  35. The concentration of blood albumin

    Time frame: baseline, pre-intervention

    blood uric acid in mg/dL

  36. The concentration of blood albumin

    Time frame: within one week after the intervention

    blood uric acid in mg/dL

  37. The concentration of blood globulin

    Time frame: baseline, pre-intervention

    blood uric acid in mg/dL

  38. The concentration of blood globulin

    Time frame: within one week after the intervention

    blood uric acid in mg/dL

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2021
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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