Diets, Lipoproteins and Inflammation Markers

Not Applicable

Completed

• Conditions: Diet, Healthy; Vegan Diet; Inflammatory Response; Cardiovascular Diseases; Metabolic Syndrome
• Interventions: Behavioral: Vegan diet

• Registration Number: NCT05423457
• Lead Sponsor: Buddhist Tzu Chi General Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-18
• Primary Completion: 2018-06-14
• Study Completion: 2018-06-15
• Status Verified: 2019-06
• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vegan diet	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.
MyPlate (Taiwanese version)	Vegan diet	Each Participant has three group sessions and three individual nutrition counseling with a dietitian.

Primary Outcome Measures

Name	Time	Method
lipoprotein particles size	12 weeks	lipoprotein particles size (nm)
Traditional cadiometabolic risk factors 1	12 weeks	TG(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), Total cholesterol(mg/dL)
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）
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 3	12 weeks	HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index)
Traditional cadiometabolic risk factors 2	12 weeks	HbA1c(%)

Trial Locations

Locations (1)

Hualien Tzu Chi Hospital; 🇨🇳 Hualien City, Taiwan