Cardioprotective Properties of Vegan Burger

NCT05582720 | Unknown

• 1 other identifier: Γ-3047/17-06-2021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

read meat; meat analogues; burger; vegan burger; dietary intervention; plant proteins; inflammation; oxidative stress; thrombosis; cardioprotection

Outcome Measures

Primary Outcomes (10)

• Change from baseline in homeostasis model of assessment - insulin resistance (HOMA-IR) at 4 weeks

  HOMA-IR will be calculated based on fasting glucose and fasting insulin levels through the Mathews equation. Fasting glucose and insulin will be measured in serum via a photometric method in a biochemical analyzer.

  0 (baseline) and 4 weeks

• Change from baseline in total cholesterol at 4 weeks

  Total cholesterol will be measured in serum via a photometric method in a biochemical analyzer.

  0 (baseline) and 4 weeks

• Change from baseline in low-density lipoprotein (LDL) cholesterol at 4 weeks

  LDL cholesterol will be measured in serum via a photometric method in a biochemical analyzer.

  0 (baseline) and 4 weeks

• Change from baseline in high-density lipoprotein (LDL) cholesterol at 4 weeks

  HDL cholesterol will be measured in serum via a photometric method in a biochemical analyzer.

  0 (baseline) and 4 weeks

• Change from baseline in triglycerides at 4 weeks

  Triglycerides will be measured in serum via a photometric method in a biochemical analyzer.

  0 (baseline) and 4 weeks

• Change from baseline in uric acid at 4 weeks

  Uric acid will be measured in serum via a photometric method in a biochemical analyzer.

  0 (baseline) and 4 weeks

• Change from baseline in urea at 4 weeks

  Urea will be measured in serum via a photometric method in a biochemical analyzer.

  0 (baseline) and 4 weeks

• Change from baseline in high sensitivity C-reactive protein (hsCRP) at 4 weeks

  hsCRP will be measured in serum via an enzyme-linked immunoassay.

  0 (baseline) and 4 weeks

• Change from baseline in systolic blood pressure (SBP) at 4 weeks

  SBP will be measured with an automatic device operating on the oscillometric principle.

  0 (baseline) and 4 weeks

• Change from baseline in diastolic blood pressure (DBP) at 4 weeks

  DBP will be measured with an automatic device operating on the oscillometric principle.

  0 (baseline) and 4 weeks

Secondary Outcomes (7)

• Change from baseline in hematocrit at 4 weeks

  0 (baseline) and 4 weeks

• Change from baseline in iron at 4 weeks

  0 (baseline) and 4 weeks

• Change from baseline in ferritin at 4 weeks

  0 (baseline) and 4 weeks

• Change from baseline in total iron binding capacity at 4 weeks

  0 (baseline) and 4 weeks

• Change from baseline in albumin at 4 weeks

  0 (baseline) and 4 weeks

Study Arms (2)

Conventional burger group

ACTIVE COMPARATOR

This arm will consume 2 portions (each 120 g cooked) of conventional burger per week for a 4-week period.

Behavioral: Conventional burger

Vegan burger group

EXPERIMENTAL

This arm will consume 2 portions (each 120 g cooked) of vegan burger per week for a 4-week period.

Behavioral: Vegan burger

Interventions

Conventional burger BEHAVIORAL

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.

Conventional burger group

Vegan burger BEHAVIORAL

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.

Vegan burger group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 30-60 years old
• Body mass index ≥25 kg/m2
• Habitual red meat consumption ≥3 portions/week (1 portion: 120 g cooked meat)

You may not qualify if:

• Presence of chronic diseases, such as diabetes mellitus, active cancer, cardiovascular, liver kidney, respiratory, gastrointestinal, chronic inflammatory and psychiatric diseases
• Reception of immunosuppressant, anti-inflammatory or cortisol medication,
• Intake of protein, amino acid, fatty acid, dietary fiber, probiotic and prebiotic supplements
• Habitual excessive alcohol consumption, i.e., \>210 g and \>140 g of ethanol per week for men and women, respectively
• Currently being on a restrictive diet (e.g., weight loss or vegetarian diet) or any significant recent change (within 6 months) in lifestyle habits
• Pregnancy and breastfeeding for women

Sponsors & Collaborators

• Harokopio University: lead
• Hellenic Catering S.A.: collaborator
• Laboratory of Design and Process Analysis, School of Chemical Engineering, National Technical University of Athens: collaborator
• Laboratory of Biotechnology, Department of Biological Applications & Technology, University of Ioannina: collaborator
• European Regional Development Fund: collaborator

Study Sites (1)

Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

Kallithea, Attica, 17676, Greece

RECRUITING

MeSH Terms

Conditions

Inflammation; Thrombosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tzortzis Nomikos, PhD

  Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

  PRINCIPAL INVESTIGATOR

• Smaragdi Antonopoulou, PhD

  Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

  STUDY CHAIR

• Elizabeth Fragopoulou, PhD

  Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

  STUDY CHAIR

• Meropi Kontogianni, PhD

  Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

  STUDY CHAIR

• Michael Georgoulis, PhD

  Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

  STUDY DIRECTOR

Central Study Contacts

Tzortzis Nomikos, PhD

CONTACT

+302109549100; tnomikos@hua.gr

Michael Georgoulis, PhD

CONTACT

+302109549100; mgeor@hua.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biochemistry

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: October 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)