Cerebrovascular DiseaseNCT05092087
Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases
An observational study of Cerebrovascular Disease, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- nutrition counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 129 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Apr 2021to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who volunteer to pay and completed nutrition consultations from Bon-Vivant Health Lifestyle Management Center.
Who may be able to join
- 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
Who cannot join
- Age <20
- pregnant
- Mental problem
- unable to do the measurement of body composition
- incomplete the nutritional counseling program
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebrovascular Disease
- Being tested
- nutrition counseling
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition counselingBehavioural
nutrition counseling
| Study group | Role | What they receive |
|---|---|---|
| Control group/ non-regularity group | those who completed 8 consultations by average interval time more than 3 weeks were in the non-regularity group Receives: Behavioral: nutrition counseling | |
| test group/ regularity group | those who completed the consultations and interval time within in 3 weeks were in the higher regularity Receives: Behavioral: nutrition counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
body weight in kilograms
Measured: baseline, pre-intervention
body weight
body weight in kilograms
Measured: immediately after the intervention
height
height in meters
Measured: baseline, pre-intervention
height
height in meters
Measured: immediately after the intervention
body mass index
body mass index in kg/m^2
Measured: baseline, pre-intervention
body mass index
body mass index in kg/m^2
Measured: immediately after the intervention
body fat
body fat in ratio
Measured: baseline, pre-intervention
body fat
body fat in ratio
Measured: immediately after the intervention
The concentration of blood triglyceride
blood triglyceride in mg/dL
Measured: baseline, pre-intervention
The concentration of blood total cholesterol
blood total cholesterol in mg/dL
Measured: within one week after the intervention
The concentration of blood low density lipoprotein-cholesterol
blood blood low density lipoprotein-cholesterol in mg/dL
Measured: baseline, pre-intervention
The concentration of blood low density lipoprotein-cholesterol
blood blood low density lipoprotein-cholesterol in mg/dL
Measured: within one week after the intervention
The concentration of blood high density lipoprotein-cholesterol-cholesterol
blood high density lipoprotein-cholesterol in mg/dL
Measured: baseline, pre-intervention
The concentration of blood high density lipoprotein-cholesterol-cholesterol
blood high density lipoprotein-cholesterol in mg/dL
Measured: within one week after the intervention
The concentration of blood high sensitive C-reactive protein
blood high sensitive sensitive C-reactive protein in mg/L
Measured: baseline, pre-intervention
The concentration of blood high sensitive C-reactive protein
blood high sensitive sensitive C-reactive protein in mg/L
Measured: within one week after the intervention
The concentration of blood fasting glucose
blood fasting glucose in mg/dL
Measured: baseline, pre-intervention
The concentration of blood fasting glucose
blood fasting glucose in mg/dL
Measured: within one week after the intervention
blood HbA1C
blood HbA1C in percentage
Measured: baseline, pre-intervention
blood HbA1C
blood HbA1C in percentage
Measured: within one week after the intervention
The concentration of blood insulin
blood insulin in mg/dL
Measured: baseline, pre-intervention
The concentration of blood insulin
blood insulin in mg/dL
Measured: within one week after the intervention
The activity of blood aspartate aminotransferase
blood aspartate aminotransferase in U/L
Measured: baseline, pre-intervention
The activity of blood aspartate aminotransferase
blood aspartate aminotransferase in U/L
Measured: within one week after the intervention
The activity of blood alanine aminotransferase
blood alanine aminotransferase in U/L
Measured: baseline, pre-intervention
The activity of blood alanine aminotransferase
blood alanine aminotransferase in U/L
Measured: within one week after the intervention
The concentration of blood urinary nitrogen (BUN)
BUN in mg/L
Measured: baseline, pre-intervention
The concentration of blood urinary nitrogen (BUN)
BUN in mg/L
Measured: within one week after the intervention
The concentration of blood creatinine
BUN in mg/dL
Measured: baseline, pre-intervention
The concentration of blood creatinine
BUN in mg/dL
Measured: within one week after the intervention
The concentration of blood uric acid
blood uric acid in mg/dL
Measured: baseline, pre-intervention
The concentration of blood uric acid
blood uric acid in mg/dL
Measured: within one week after the intervention
The concentration of blood total protein
blood uric acid in mg/dL
Measured: baseline, pre-intervention
The concentration of blood total protein
blood uric acid in mg/dL
Measured: within one week after the intervention
The concentration of blood albumin
blood uric acid in mg/dL
Measured: baseline, pre-intervention
The concentration of blood albumin
blood uric acid in mg/dL
Measured: within one week after the intervention
The concentration of blood globulin
blood uric acid in mg/dL
Measured: baseline, pre-intervention
The concentration of blood globulin
blood uric acid in mg/dL
Measured: within one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start21 Apr 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suh-Ching Yang, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092087
- Sponsor's protocol ID
- N202103134
- Status last verified
- Apr 2021
- First submitted
- 1 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Counseling Regularity on the Risk of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT05092087
- Acronym / sponsor ID
- N202103134
- Conditions
- Cerebrovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group/ non-regularity group | – | Behavioral: nutrition counselingthose who completed 8 consultations by average interval time more than 3 weeks were in the non-regularity group |
| test group/ regularity group | – | Behavioral: nutrition counselingthose who completed the consultations and interval time within in 3 weeks were in the higher regularity |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who volunteer to pay and completed nutrition consultations from Bon-Vivant Health Lifestyle Management Center.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Age <20
- pregnant
- Mental problem
- unable to do the measurement of body composition
- incomplete the nutritional counseling program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition counselingnutrition counseling | Behavioural | Control group/ non-regularity group, test group/ regularity group |
Primary outcome
body weight
Time frame: baseline, pre-intervention
body weight in kilograms
body weight
Time frame: immediately after the intervention
body weight in kilograms
height
Time frame: baseline, pre-intervention
height in meters
height
Time frame: immediately after the intervention
height in meters
body mass index
Time frame: baseline, pre-intervention
body mass index in kg/m^2
body mass index
Time frame: immediately after the intervention
body mass index in kg/m^2
body fat
Time frame: baseline, pre-intervention
body fat in ratio
body fat
Time frame: immediately after the intervention
body fat in ratio
The concentration of blood triglyceride
Time frame: baseline, pre-intervention
blood triglyceride in mg/dL
The concentration of blood total cholesterol
Time frame: within one week after the intervention
blood total cholesterol in mg/dL
The concentration of blood low density lipoprotein-cholesterol
Time frame: baseline, pre-intervention
blood blood low density lipoprotein-cholesterol in mg/dL
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 high density lipoprotein-cholesterol-cholesterol
Time frame: baseline, pre-intervention
blood high density lipoprotein-cholesterol in mg/dL
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 high sensitive C-reactive protein
Time frame: baseline, pre-intervention
blood high sensitive sensitive C-reactive protein in mg/L
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 fasting glucose
Time frame: baseline, pre-intervention
blood fasting glucose in mg/dL
The concentration of blood fasting glucose
Time frame: within one week after the intervention
blood fasting glucose in mg/dL
blood HbA1C
Time frame: baseline, pre-intervention
blood HbA1C in percentage
blood HbA1C
Time frame: within one week after the intervention
blood HbA1C in percentage
The concentration of blood insulin
Time frame: baseline, pre-intervention
blood insulin in mg/dL
The concentration of blood insulin
Time frame: within one week after the intervention
blood insulin in mg/dL
The activity of blood aspartate aminotransferase
Time frame: baseline, pre-intervention
blood aspartate aminotransferase in U/L
The activity of blood aspartate aminotransferase
Time frame: within one week after the intervention
blood aspartate aminotransferase in U/L
The activity of blood alanine aminotransferase
Time frame: baseline, pre-intervention
blood alanine aminotransferase in U/L
The activity of blood alanine aminotransferase
Time frame: within one week after the intervention
blood alanine aminotransferase in U/L
The concentration of blood urinary nitrogen (BUN)
Time frame: baseline, pre-intervention
BUN in mg/L
The concentration of blood urinary nitrogen (BUN)
Time frame: within one week after the intervention
BUN in mg/L
The concentration of blood creatinine
Time frame: baseline, pre-intervention
BUN in mg/dL
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: baseline, pre-intervention
blood uric acid 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 total protein
Time frame: baseline, pre-intervention
blood uric acid in mg/dL
The concentration of blood total protein
Time frame: within one week after the intervention
blood uric acid in mg/dL
The concentration of blood albumin
Time frame: baseline, pre-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
The concentration of blood globulin
Time frame: baseline, pre-intervention
blood uric acid in mg/dL
The concentration of blood globulin
Time frame: within one week after the intervention
blood uric acid in mg/dL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suh-Ching Yang study chair
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disease, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: baseline, pre-intervention). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.