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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000011987
Enrollment
0
Registered
2020-01-09
Start date
2020-11-05
Completion date
Unknown
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 Bur

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.

Sponsors

Associate Professor Michael Skilton
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy adults with a BMI less than 30kg/m2, who currently consuming red meat within the NHMRC dietary guidelines

Exclusion criteria

Current smokers or those who have ceased smoking within the past six months; women who are pregnant or breastfeeding; individuals who have previously been diagnosed with cardiovascular disease, hypertension, pre-diabetes, type 1 diabetes, type 2 diabetes, gastrointestinal disorders or any other major illness; currently using lipid-lowering or vasoactive medications (e.g. anti-hypertensives); those who have any known food intolerances or allergies.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026