Diets, Lipoproteins and Inflammation Markers

Buddhist Tzu Chi General Hospital

Status: Completed

Conditions: Inflammatory Response; Vegan Diet; Cardiovascular Diseases; Diet, Healthy; Metabolic Syndrome

Treatments: Behavioral: Vegan diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05423457

IRB106-92-B

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Vegan diet

Experimental group

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.

Treatment:

Behavioral: Vegan diet

MyPlate (Taiwanese version)

Active Comparator group

Description:

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

Treatment:

Behavioral: Vegan diet