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Diets, Lipoproteins and Inflammation Markers

Primary Purpose

Cardiovascular Diseases, Metabolic Syndrome, Diet, Healthy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vegan diet
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Diseases

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hualien Tzu Chi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vegan diet

MyPlate (Taiwanese version)

Arm Description

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.

Each Participant has three group sessions and three individual nutrition counseling with a dietitian.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 30, 2022
Last Updated
February 17, 2023
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05423457
Brief Title
Diets, Lipoproteins and Inflammation Markers
Official Title
Effectiveness of Vegan Diet and MyPlate Diet (Taiwanese Version) on Lipoproteins, Novel Markers of Cardiovascular Diseases, and Traditional Cardiometabolic Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Metabolic Syndrome, Diet, Healthy, Vegan Diet, Inflammatory Response

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vegan diet
Arm Type
Experimental
Arm Description
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.
Arm Title
MyPlate (Taiwanese version)
Arm Type
Active Comparator
Arm Description
Each Participant has three group sessions and three individual nutrition counseling with a dietitian.
Intervention Type
Behavioral
Intervention Name(s)
Vegan diet
Intervention Description
The participants were advised to eat foods in their original type.
Primary Outcome Measure Information:
Title
Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration
Description
GlycA (umol/L), lipoprotein particles concentration(umol/L)
Time Frame
12 weeks
Title
Lipoprotein particles concentration
Description
lipoprotein particles concentration (nmol/L）
Time Frame
12 weeks
Title
lipoprotein particles size
Description
lipoprotein particles size (nm)
Time Frame
12 weeks
Title
Trimethylamine-N-oxide
Description
TMAO (uM). TMAO is a low molecular weight compound that belongs to the class of amine oxides
Time Frame
12 weeks
Title
Traditional cadiometabolic risk factors 1
Description
TG(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), Total cholesterol(mg/dL)
Time Frame
12 weeks
Title
Traditional cadiometabolic risk factors 2
Description
HbA1c(%)
Time Frame
12 weeks
Title
Traditional cadiometabolic risk factors 3
Description
HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Diets, Lipoproteins and Inflammation Markers

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