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OpenTrials
Completed

NCT Number: NCT05423457

Diets, Lipoproteins and Inflammation Markers

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

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Key information

Conditions

Cardiovascular Diseases Diet, Healthy Glucose Metabolism Disorders Hyperinsulinism Inflammatory Response Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Vegan Diet

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vegan diet

Behavioral

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

Primary outcomes

  1. Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration

    Time frame: 12 weeks

    GlycA (umol/L), lipoprotein particles concentration(umol/L)

  2. Lipoprotein particles concentration

    Time frame: 12 weeks

    lipoprotein particles concentration (nmol/L）

  3. lipoprotein particles size

    Time frame: 12 weeks

    lipoprotein particles size (nm)

  4. Trimethylamine-N-oxide

    Time frame: 12 weeks

    TMAO (uM). TMAO is a low molecular weight compound that belongs to the class of amine oxides

  5. Traditional cadiometabolic risk factors 1

    Time frame: 12 weeks

    TG(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), Total cholesterol(mg/dL)

  6. Traditional cadiometabolic risk factors 2

    Time frame: 12 weeks

    HbA1c(%)

  7. Traditional cadiometabolic risk factors 3

    Time frame: 12 weeks

    HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index)

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2022
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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