Vegetarian Diet in Patients With Ischemic Heart Disease

Ischemic Heart Disease Clinical Trial

— VERDI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942628
• Other study ID #: Regionorebrolan
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: February 2020
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stable ischemic heart disease and previous percutaneous coronary intervention (PCI.

• Under optimal medical treatment including aspirin and cholesterol lowering drugs (statins)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• Vegetarian diet followed by meat diet or vice versa
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.

Locations

Country	Name	City	State
Sweden	Regionorebrolan	Örebro

Sponsors (3)

Lead Sponsor	Collaborator
Region Örebro County	Göteborg University, Swedish University of Agricultural Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in oxidative stress evaluated by oxidized LDL cholesterol changes		4 weeks
Secondary	Changes in cardiovascular risk profile according to the Framingham Risk Score		4 weeks
Secondary	Changes in biomarkers of inflammation	Markers: hs-CRP (high sensitivity C-reactive protein), IL-6 (interleukin 6), TNF-a (tumor necrosis factor a), interferon gamma (IFN-?).	4 weeks
Secondary	Changes in biomarkers of lipid status	Markers: total cholesterol, LDL-cholesterol, TGA (triacylglycerides), apolipoprotein B, apolipoprotein A1, HDL cholesterol.	4 weeks
Secondary	Changes in HbA1c		4 weeks
Secondary	Changes in TMAO levels in plasma	TMAO: trimethylamine N-oxide assessed by stable isotope dilution high-performance liquid chromatography.	4 weeks
Secondary	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.	4 weeks