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Ischemic Heart DiseaseVERDINCT02942628

Vegetarian Diet in Patients With Ischemic Heart Disease

A study testing Vegetarian diet followed by meat diet or vice versa in people with Ischemic Heart Disease, run by Region Örebro County at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Heart Disease
What is being tested?
Vegetarian diet followed by meat diet or vice versa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSweden
Study dates
1 Oct 2017to 1 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Regionorebrolan

    Örebro

Other trials in Sweden

About this study

Official title: Vegetarian Diet in Patients With Ischemic Heart Disease: An Open-label, Randomized, Prospective Crossover Study

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.

Read the detailed description

Background

Cardiovascular disease is the leading cause of death globally. Ischemic heart disease (IHD) contributes the most to this statistic and since 1990 the global burden of IHD has increased. It is estimated that 50 000 Swedish patients are hospitalized every year due to IHD. The risk of developing IHD is to a large extent determined by the existence and state of several modifiable risk factors including dietary habits, smoking, hypertension, diabetes mellitus, hyperlipidemia, high apolipoprotein B/ apolipoprotein A1-ratio, abdominal obesity, physical inactivity, alcohol consumption and psychosocial factors. High levels of oxidative stress, oxidized LDL cholesterol and the microbial metabolite trimethylamine N-oxide TMAO have been suggested to be associated with development of IHD.

A plant-based (vegetarian) diet may provide cardiovascular health benefits through various mechanisms. Clinical studies suggest that a vegetarian diet has positive effects on low-density lipoprotein (LDL) cholesterol, oxidized LDL cholesterol, total cholesterol, triglycerides, apolipoprotein B, body mass index (BMI), inflammatory markers, blood pressure, arterial intima-media thickness, insulin sensitivity, glycated hemoglobin, (HbA1c) and fasting glucose levels. Through positive impacts on risk factors that a vegetarian diet is associated with a lowered incidence and mortality of IHD and an overall reduced mortality.

A weakness of several prior long-term controlled studies comparing vegetarian and meat-containing diets is the lack of well-defined control diets leading to study heterogeneity. For example, some of the subjects on meat-containing diets consume great quantities of red meat, others eat substantial amounts of processed meat products and some eat mostly white meat and fish complicating interpretation of outcome. In cross-sectional or observational cohort studies comparing long-term vegetarians to long-term omnivores, results may be influenced by other lifestyle choices besides the studied diet, such as smoking and exercise.Furthermore, the participants in many previous studies were often healthy volunteers and not patients with overt cardiovascular disease.

Purpose

The objective is to perform an 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: lipids, inflammation, oxidative stress, BMI, HbA1c, apolipoprotein B/apolipoprotein A1-ratio, gut microbiota, endothelial function and quality of life. The study will be conducted in patients diagnosed with STEMI (ST-segment elevation myocardial infarction), non-STEMI (non-ST-segment elevation myocardial infarction) or angina pectoris and treated by percutaneous coronary intervention (PCI).

Hypothesis

The study hypothesis is that patients diagnosed with IHD can 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.

Clinical relevance

During the last decades the global mortality from IHD has remained unchanged regardless of development of new invasive and pharmacological treatments. Despite the fact that the prevalence and mortality from IHD have decreased in this country since 1990 and that the decrease most likely is due to lifestyle changes, IHD remains the leading cause of death in Sweden.

Being tested
Vegetarian diet followed by meat diet or vice versa
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02942628
Study groupRoleWhat they receive
Vegetarian - MeatExperimental4 weeks of vegetarian diet followed by 4 weeks of 'wash out' (no intervention) and 4 weeks of meat-containing diet
Receives: Other: Vegetarian diet followed by meat diet or vice versa
Meat - VegetarianActive comparator4 weeks of meat-containing diet followed by 4 weeks of 'wash out' (no intervention) and 4 weeks of vegetarian diet
Receives: Other: Vegetarian diet followed by meat diet or vice versa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in oxidative stress evaluated by oxidized LDL cholesterol changes

    Measured: 4 weeks

Secondary outcomes (6)
  1. Changes in cardiovascular risk profile according to the Framingham Risk Score

    Measured: 4 weeks

  2. Changes in biomarkers of inflammation

    Markers: hs-CRP (high sensitivity C-reactive protein), IL-6 (interleukin 6), TNF-α (tumor necrosis factor α), interferon gamma (IFN-γ).

    Measured: 4 weeks

  3. Changes in biomarkers of lipid status

    Markers: total cholesterol, LDL-cholesterol, TGA (triacylglycerides), apolipoprotein B, apolipoprotein A1, HDL cholesterol.

    Measured: 4 weeks

  4. Changes in HbA1c

    Measured: 4 weeks

  5. Changes in TMAO levels in plasma

    TMAO: trimethylamine N-oxide assessed by stable isotope dilution high-performance liquid chromatography.

    Measured: 4 weeks

  6. Changes in gut microbiota

    Assessment of: Bacteroides, Prevotella, Bacteroides-Prevotella, Bacteroides thetaiotaomicron, Clostridium clostridioforme and Faecalibacterium prausnitzii and 16S rRNA profiling and next-generation sequencing to analyze the gut microbiome.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2016 (estimated)
  2. Study start1 Oct 2017
  3. Primary completion1 Oct 2018
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02942628
Sponsor's protocol ID
Regionorebrolan
Acronym
VERDI
Status last verified
Feb 2020
First submitted
20 Oct 2016
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32893710

Questions about this trial

What is this clinical trial studying?

A study testing Vegetarian diet followed by meat diet or vice versa in people with Ischemic Heart Disease, run by Region Örebro County at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in oxidative stress evaluated by oxidized LDL cholesterol changes (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02942628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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