Cardioprotective Properties of Vegan Burger

Summary

Several studies over the last decades have demonstrated the important role of nutrition in the development of chronic diseases, such as cardiovascular disease and cancer. One dietary component that has been in the center of scientific research is red meat and processed meat (e.g., cold cuts, sausages, burgers). Burger, in particular, is one of the most popular red meat products and its consumption has increased rapidly in recent years due to the expansion of fast-food restaurants, its wide availability and its low price. However, due to its high animal fat content which is mostly saturated and high degree of processing, its nutritional value and the safety of its long-term high consumption have been questioned. The wide acceptance of burger by the general population, combined with the perception that it is a "burdensome" food for health, makes it an ideal subject for interventions aiming at modifying its nutritional value without downgrading its organoleptic characteristics and increasing its cost. Such an approach could be applied to the meat industry in order to develop innovative, functional meat analogues of high nutritional and organoleptic value, which could find acceptance by both meat-eating and vegetarian/vegan populations. Therefore, the aim of the present double-blind, randomized, crossover clinical trial is to explore the potential cardioprotective properties of "vegan burger", a novel meat analogue developed through the substitution of animal proteins and lipids with plant-based constituents using innovative technologies, against the conventional animal-based burger, in apparently healthy volunteers.

Conditions

• Cardiometabolic Health

Interventions

BEHAVIORAL

Conventional burger

Participants initially randomized to this intervention arm will be provided with a total of 8 conventional burgers and will be asked to consume them twice weekly for 4 weeks. Conventional burgers will be produced by Hellenic Catering S.A. using standard procedures. Participants will also be instructed to maintain their usual dietary intake, physical activity level, prescribed medications and dietary supplements, as well as to refrain from any weight loss effort during the intervention. After a 2-week wash-out period (no burger consumption), participants will cross over to the other intervention arm.

BEHAVIORAL

Vegan burger

Participants initially randomized to this intervention arm will be provided with a total of 8 vegan burgers and will be asked to consume them twice weekly for 4 weeks. Vegan burgers will be produced by Hellenic Catering S.A. using novel technologies. Participants will also be instructed to maintain their usual dietary intake, physical activity level, prescribed medications and dietary supplements, as well as to refrain from any weight loss effort during the intervention. After a 2-week wash-out period (no burger consumption), participants will cross over to the other intervention arm.

Sponsors & Collaborators

• Hellenic Catering S.A.

  collaborator UNKNOWN

• Laboratory of Design and Process Analysis, School of Chemical Engineering, National Technical University of Athens

  collaborator UNKNOWN

• Laboratory of Biotechnology, Department of Biological Applications & Technology, University of Ioannina

  collaborator UNKNOWN

• European Regional Development Fund

  collaborator OTHER

• Harokopio University

  lead OTHER

Principal Investigators

• Tzortzis Nomikos, PhD · Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

• Smaragdi Antonopoulou, PhD · Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

• Elizabeth Fragopoulou, PhD · Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

• Meropi Kontogianni, PhD · Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

• Michael Georgoulis, PhD · Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2023-05-31

Completion

2023-05-31

Countries

• Greece

Study Locations