Diets, Lipoproteins and Inflammation Markers

NCT05423457 | Completed

• 1 other identifier: IRB106-92-B
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration

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

  12 weeks

• Lipoprotein particles concentration

  lipoprotein particles concentration (nmol/L）

  12 weeks

• lipoprotein particles size

  lipoprotein particles size (nm)

  12 weeks

• Trimethylamine-N-oxide

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

  12 weeks

• Traditional cadiometabolic risk factors 1

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

  12 weeks

• Traditional cadiometabolic risk factors 2

  HbA1c(%)

  12 weeks

• Traditional cadiometabolic risk factors 3

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

  12 weeks

Study Arms (2)

Vegan diet

EXPERIMENTAL

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

MyPlate (Taiwanese version)

ACTIVE COMPARATOR

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

Behavioral: Vegan diet

Interventions

Vegan diet BEHAVIORAL

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

MyPlate (Taiwanese version); Vegan diet

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• chronic kidney disease
• history of coronary artery disease
• ischemic heart disease,
• heart failure,
• stroke,
• cancer of any type

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Interventions

Diet, Vegan

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 21, 2022
• Study Start: July 18, 2017
• Primary Completion: June 14, 2018
• Study Completion: June 15, 2018
• Last Updated: February 21, 2023

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)