NCT02942628

Brief Summary

Open label, 4 week randomized, cross-over study to compare the effect of a vegetarian diet to a conventional (meat containing) diet based on the Swedish average meat consumption on a range of parameters with prognostic importance for cardiovascular disease.The study will be conducted in patients diagnosed with ischemic heart disease. We hypothesize that patients will benefit from a vegetarian diet as assessed by multiple risk markers for this type of disease with a primary focus on changes in oxidized LDL cholesterol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

October 20, 2016

Last Update Submit

February 12, 2020

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Change in oxidative stress evaluated by oxidized LDL cholesterol changes

    4 weeks

Secondary Outcomes (6)

  • Changes in cardiovascular risk profile according to the Framingham Risk Score

    4 weeks

  • Changes in biomarkers of inflammation

    4 weeks

  • Changes in biomarkers of lipid status

    4 weeks

  • Changes in HbA1c

    4 weeks

  • Changes in TMAO levels in plasma

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Vegetarian - Meat

EXPERIMENTAL

4 weeks of vegetarian diet followed by 4 weeks of 'wash out' (no intervention) and 4 weeks of meat-containing diet

Other: Vegetarian diet followed by meat diet or vice versa

Meat - Vegetarian

ACTIVE COMPARATOR

4 weeks of meat-containing diet followed by 4 weeks of 'wash out' (no intervention) and 4 weeks of vegetarian diet

Other: Vegetarian diet followed by meat diet or vice versa

Interventions

Vegetarian diet followed by meat diet or vice versaOTHER

Half the patients will follow either a vegetarian diet for 6 weeks and the other half will adhere to or a meat-based diet for six weekd. This is followed by a 4 week period where patients eat their usual diet. Thereafter patients initially randomized to a vegetarian diet will follow a meat-based diet for six weeks while the patients initially randomized to meat will follow a vegetarian diet for six weeks.

Meat - VegetarianVegetarian - Meat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable ischemic heart disease and previous percutaneous coronary intervention (PCI.
  • Under optimal medical treatment including aspirin and cholesterol lowering drugs (statins)

You may not qualify if:

  • PCI treatment during the last 30 days
  • Inability to provide informed consent
  • Already following a vegetarian or a vegan diet
  • Known vitamin B deficiency
  • Known food allergy
  • Previous obesity surgery or gastric bypass surgery
  • Life expectancy \<1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regionorebrolan

Örebro, Sweden

Location

Related Publications (1)

  • Djekic D, Shi L, Brolin H, Carlsson F, Sarnqvist C, Savolainen O, Cao Y, Backhed F, Tremaroli V, Landberg R, Frobert O. Effects of a Vegetarian Diet on Cardiometabolic Risk Factors, Gut Microbiota, and Plasma Metabolome in Subjects With Ischemic Heart Disease: A Randomized, Crossover Study. J Am Heart Assoc. 2020 Sep 15;9(18):e016518. doi: 10.1161/JAHA.120.016518. Epub 2020 Sep 6.

    PMID: 32893710DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Demir Djekic, MD

    Region Örebro County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 24, 2016

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

June 1, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

SE(1)