Diets, Lipoproteins and Inflammation Markers

NCT ID: NCT05423457

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2018-06-15

Brief Summary

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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

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Conditions

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Cardiovascular Diseases Metabolic Syndrome Diet, Healthy Vegan Diet Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vegan diet

Intervention Type BEHAVIORAL

The participants were advised to eat foods in their original type.

MyPlate (Taiwanese version)

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

Group Type ACTIVE_COMPARATOR

Vegan diet

Intervention Type BEHAVIORAL

The participants were advised to eat foods in their original type.

Interventions

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Vegan diet

The participants were advised to eat foods in their original type.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* chronic kidney disease
* history of coronary artery disease
* ischemic heart disease,
* heart failure,
* stroke,
* cancer of any type
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hualien Tzu Chi Hospital

Hualien City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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IRB106-92-B

Identifier Type: -

Identifier Source: org_study_id

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