RecruitingACTRN12620000011987

The acute effect of plant-based meat-alternatives on arterial endothelial function and cardiovascular risk markers


Sponsor

Associate Professor Michael Skilton

Enrollment

25 participants

Start Date

Nov 5, 2020

Study Type

Interventional

Conditions

Summary

The consumption of red meat and processed red meat is associated with cardiovascular disease and mortality risk. There is strong evidence that plant-based sources of protein are associated with beneficial outcomes, particularly when replacing red meat in the diet. This project will be looking at the effect of a plant-based meat-alternative burger versus a traditional meat burger on post-meal biomarkers including TMAO, triglycerides, as well as endothelial function in 20 healthy human adults, aged 18-45 years. Participants will be given one of the two types of burger on each visit, after an overnight fast. A blood sample and an ultrasound will be taken at before consuming the meal, and 2 hours and 4 hours post-meal. An additional blood sample will be taken at 24 hours post-meal. Cardiovascular risk factors including LDL-cholesterol, triglycerides, IL-6, glucose, blood pressure and body weight will also be assessed at each visit.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Many people are now choosing plant-based meat alternatives as a healthier or more sustainable option, but we don't yet have strong evidence on how these products compare to traditional meat in terms of their immediate effects on heart health. This study directly compares a plant-based burger with a conventional meat burger to see how each affects markers of cardiovascular risk in the hours after eating. Participants will visit the research centre twice — once eating each type of burger after an overnight fast. Blood samples will be collected before eating and at 2, 4, and 24 hours after the meal. An ultrasound of the blood vessels will also be taken at each time point to measure how well the arteries are functioning (called endothelial function), along with measurements of blood pressure, cholesterol, and other heart health markers. This study is looking for healthy adults aged 18 to 45 with a BMI under 30 who currently eat red meat within national dietary guidelines. People who smoke, are pregnant or breastfeeding, have been diagnosed with cardiovascular disease, diabetes, high blood pressure, or gastrointestinal disorders, or who currently take cholesterol-lowering medications are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will be invited to the CPC RPA clinic on four occasions. Participants will be asked to moderate their red meat intake for two days prior (no more than a serve per day) and fast for at lea

Participants will be invited to the CPC RPA clinic on four occasions. Participants will be asked to moderate their red meat intake for two days prior (no more than a serve per day) and fast for at least 10 hours prior to study visits 1 & 3. During study visits 1 & 3, participants will consume two burgers in a randomized order (one during each study) with a minimum of 4 weeks apart. The two burgers will be 1) a burger made with a beef patty, or 2) a plant-based meat-alternative burger (Beyond Burger, ingredients include peas protein, bean protein, rice protein, etc.). The size of the animal-derived meat patty will be matched with the Beyond Burger patty (1/4 lb raw weight, i.e., 113 grams). The burgers will differ only in their patty; other components will be identical (bun, sauce, salad). All intervention food will be consumed under supervision. All burgers will be prepared in the metabolic kitchen of the CPC RPA clinic, The University of Sydney, by researchers hold a Food Handling Level 1 Certificate. The participants will return for study visits 2 & 4, undertaken the day after visits 1 & 3, respectively. Study visits 2 & 4 will consist of an additional venous blood sample (no more than 20mL, approximately 24 hours post-meal). Participants will be instructed to not consume red meat or processed meat in the 24-hour period between visits 1 & 2, and visits 3 & 4.


Locations(1)

NSW, Australia

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ACTRN12620000011987