Diets, Lipoproteins and Inflammation Markers

February 17, 2023 updated by: Buddhist Tzu Chi General Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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