Cardiovascular Diseases Clinical Trial
Official title:
Effectiveness of Vegan Diet and MyPlate Diet (Taiwanese Version) on Lipoproteins, Novel Markers of Cardiovascular Diseases, and Traditional Cardiometabolic Risk Factors
NCT number | NCT05423457 |
Other study ID # | IRB106-92-B |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2017 |
Est. completion date | June 15, 2018 |
Verified date | June 2019 |
Source | Buddhist Tzu Chi General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Systematic inflammation and lipid profiles are two major therapeutic targets for cardiovascular diseases. The effectiveness of vegan diet has been reported (doi: 10.3389/fnut.2022.807810). Aim: To compare the effectiveness of a nutritionally balanced vegan diet and a Myplate diet ((Taiwanese version) on systematic inflammation and lipoprotein subclass. Design: Randomized crossover design
Status | Completed |
Enrollment | 21 |
Est. completion date | June 15, 2018 |
Est. primary completion date | June 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: Patients with dyslipidemia (at least one of the following) - TG = 150 mg/dL - TC = 200 mg/dL - LDL-c= 130 mg/dL, - HDL-c < 45 mg/dL for male or < 55 mg/dL for female or receiving statin treatment Exclusion Criteria (fulfill one of the following condition): - chronic kidney disease - history of coronary artery disease - ischemic heart disease, - heart failure, - stroke, - cancer of any type |
Country | Name | City | State |
---|---|---|---|
Taiwan | Hualien Tzu Chi Hospital | Hualien City |
Lead Sponsor | Collaborator |
---|---|
Buddhist Tzu Chi General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration | GlycA (umol/L), lipoprotein particles concentration(umol/L) | 12 weeks | |
Primary | Lipoprotein particles concentration | lipoprotein particles concentration (nmol/L) | 12 weeks | |
Primary | lipoprotein particles size | lipoprotein particles size (nm) | 12 weeks | |
Primary | Trimethylamine-N-oxide | TMAO (uM). TMAO is a low molecular weight compound that belongs to the class of amine oxides | 12 weeks | |
Primary | Traditional cadiometabolic risk factors 1 | TG(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), Total cholesterol(mg/dL) | 12 weeks | |
Primary | Traditional cadiometabolic risk factors 2 | HbA1c(%) | 12 weeks | |
Primary | Traditional cadiometabolic risk factors 3 | HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index) | 12 weeks |
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