Diets, Lipoproteins and Inflammation Markers

Study Overview
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Brief Summary
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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

Official Title
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Effectiveness of Vegan Diet and MyPlate Diet (Taiwanese Version) on Lipoproteins, Novel Markers of Cardiovascular Diseases, and Traditional Cardiometabolic Risk Factors

Conditions
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Cardiovascular Diseases, Metabolic Syndrome, Diet, Healthy, Vegan Diet, Inflammatory Response

Intervention / Treatment
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* Behavioral: Vegan diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vegan diet<br>Participants were provided with and instructed to eat these foods: flaxseed meal, walnuts, pecans, extra-virgin olive oil, Brazil nuts Taiwanese purple laver (also known as hong-mao-tai or Bangia atropurpurea, and was selected to test for its vitamin B12 bioavailability). Each Participant has three group sessions and three individual nutrition counseling with a dietitian. | Behavioral: Vegan diet<br>* The participants were advised to eat foods in their original type.<br>|
| Active Comparator: MyPlate (Taiwanese version)<br>Each Participant has three group sessions and three individual nutrition counseling with a dietitian. | Behavioral: Vegan diet<br>* The participants were advised to eat foods in their original type.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration | GlycA (umol/L), lipoprotein particles concentration(umol/L) | 12 weeks | 
| Lipoprotein particles concentration | lipoprotein particles concentration (nmol/L） | 12 weeks | 
| lipoprotein particles size | lipoprotein particles size (nm) | 12 weeks | 
| Trimethylamine-N-oxide | TMAO (uM). TMAO is a low molecular weight compound that belongs to the class of amine oxides | 12 weeks | 
| Traditional cadiometabolic risk factors 1 | TG(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), Total cholesterol(mg/dL) | 12 weeks | 
| Traditional cadiometabolic risk factors 2 | HbA1c(%) | 12 weeks | 
| Traditional cadiometabolic risk factors 3 | HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index) | 12 weeks |