Diets, Lipoproteins and Inflammation Markers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423457
• Other study ID #: IRB106-92-B
• Status: Completed
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: June 2019
• Source: Buddhist Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Vegan diet
The participants were advised to eat foods in their original type.

Locations

Country	Name	City	State
Taiwan	Hualien Tzu Chi Hospital	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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