Diets, Lipoproteins and Inflammation Markers

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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Metabolic Syndrome; Inflammatory Response; Diet, Healthy; Vegan Diet
• Intervention / Treatment: Behavioral: Vegan diet

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hualien City, Taiwan
    • Hualien Tzu Chi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vegan diet; 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; The participants were advised to eat foods in their original type.
Active Comparator: MyPlate (Taiwanese version); Each Participant has three group sessions and three individual nutrition counseling with a dietitian.	Behavioral: Vegan diet; The participants were advised to eat foods in their original type.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): June 14, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome
• Other Study ID Numbers: IRB106-92-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No