Diets, Lipoproteins and Inflammation Markers

Sponsor

Buddhist Tzu Chi General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05423457

Collaborator

(none)

Enrollment

Location

Arms

10.9

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Metabolic Syndrome Diet, Healthy Vegan Diet Inflammatory Response	Behavioral: Vegan diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jul 18, 2017

Actual Primary Completion Date :

Jun 14, 2018

Actual Study Completion Date :

Jun 15, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hualien Tzu Chi Hospital	Hualien City		Taiwan

Sponsors and Collaborators

Buddhist Tzu Chi General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Buddhist Tzu Chi General Hospital

ClinicalTrials.gov Identifier:

NCT05423457

Other Study ID Numbers:

IRB106-92-B

First Posted:

Jun 21, 2022

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Metabolic Syndrome

Study Results

No Results Posted as of Jun 21, 2022