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临床试验/NCT05582720
NCT05582720招募中不适用

Development of Innovative Functional Meat Analogues Using Alternative Sources of Plant Proteins and Novel Technologies

Harokopio University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Change from baseline in systolic blood pressure (SBP) at 4 weeks

研究概览

简要总结

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.

详细描述

The nutritional value and health effects of red meat and processed meat products (e.g., cold cuts, sausages, burgers) remain the object of intense research and scientific controversy in the fields of Nutrition and Food Science. Red meat is a rich source of macronutrients (e.g., proteins of high biological value) and several micronutrients (e.g., iron), and a food group particularly appealing to consumers. However, in recent years there has been an increase in the total consumption of red meat and processed meat products in developed countries, which has been associated with both increased risk of chronic diseases (e.g., cardiovascular diseases, obesity, diabetes mellitus, various types of cancer and autoimmune diseases) and increased total mortality. The aggravating effect of red meat consumption on health is likely attributed to its increased content of saturated fatty acids, which have been associated with the occurrence of insulin resistance, dyslipidemia, and disturbances in the intestinal microbiota, as well as other components produced during its processing (e.g., oxidized forms of fat, heterocyclic amines, polycyclic aromatic hydrocarbons), which can trigger mechanisms of inflammation, oxidative stress and carcinogenesis, and further contribute to the pathogenesis of cardiometabolic and neoplastic diseases. Based on the available research data, scientific associations and health organizations at the local and international level recommend limiting the consumption of red meat and meat products and replacing them with products of plant origin in the context of adopting a balanced health-promoting diet and reducing the risk of chronic cardiometabolic disorders in the general population.

Burger is one of the most popular 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 content in animal fat, which is mostly saturated, 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 simultaneously degrading 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 value, which could also find acceptance by meat-eating populations. The challenges in this direction are many, such as the reduction of lipids and/or the replacement of saturated fatty acids with other health-beneficial lipids without degrading the texture and taste of the product, and the replacement of animal proteins with plant proteins. Until now, the majority of commercially available meat analogs are made from soy protein or gluten. However, protein products have also been developed from other raw materials, including vegetables and legumes (e.g., peas and chickpeas). In addition, protein products from fungi and bacteria are available, which are suitable for reproducing the taste and texture of meat. Regarding fat, various ingredients have also been explored as substitutes for animal fat, such as dietary fiber and vegetable oils.

The aim of the present study is to explore the potential cardio-protective effects of an innovative burger of high nutritional and organoleptic value (vegan burger), developed through the substitution of animal proteins and lipids with plant-based constituents using innovative technologies, compared to a conventional burger, in apparently healthy subjects.

The study will be a randomized, cross-over, double blind clinical trial. The study sample will consist of 15 apparently healthy subjects aged 30-60 years, with a body mass index of ≥25 kg/m2 and a habitual red meat consumption of ≥3 times/week. Candidates will be excluded from the study on the basis of the following: i) presence of chronic diseases, such as diabetes mellitus, active cancer, cardiovascular, liver kidney, respiratory, gastrointestinal, chronic inflammatory and psychiatric diseases; ii) use of certain types of medication, i.e., immunosuppressants, anti-inflammatory drugs and cortisol, and dietary supplements, i.e., protein, amino acids, fatty acids, dietary fiber, probiotics and prebiotics (other prescribed medications and micronutrient supplements will be allowed, provided that their reception will remain stable throughout the trial); iii) habitual excessive consumption of alcohol (>210 g and >140 g of ethanol per week for men and women, respectively), iv) currently being on a restrictive diet (e.g., weight loss or vegetarian diet) or any significant recent change (within 6 months) in lifestyle habits, and v) pregnancy and breastfeeding for women.

Participants will be randomized to consume 2 servings per week of either a conventional burger or a vegan burger (serving size: 150 g of raw product corresponding to 120 g of cooked product) for 4 weeks, with a 2-week wash-out period between the two interventions. Randomization will be performed by a researcher with no clinical involvement in the study and will be blind to all members of the research team.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 0 (baseline) and 4 weeks

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

Change from baseline in triglycerides at 4 weeks

时间窗: 0 (baseline) and 4 weeks

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

Change from baseline in uric acid at 4 weeks

时间窗: 0 (baseline) and 4 weeks

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

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

时间窗: 0 (baseline) and 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.

Change from baseline in total cholesterol at 4 weeks

时间窗: 0 (baseline) and 4 weeks

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

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

时间窗: 0 (baseline) and 4 weeks

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

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

时间窗: 0 (baseline) and 4 weeks

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

Change from baseline in urea at 4 weeks

时间窗: 0 (baseline) and 4 weeks

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

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

时间窗: 0 (baseline) and 4 weeks

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

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

时间窗: 0 (baseline) and 4 weeks

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

次要结局

  • 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 alanine aminotransferase (ALT) at 4 weeks(0 (baseline) and 4 weeks)
  • Change from baseline in gamma-glutamyl transferase (GGT) 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 hematocrit at 4 weeks(0 (baseline) and 4 weeks)
  • Change from baseline in albumin at 4 weeks(0 (baseline) and 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tzortzis Nomikos

Associate Professor of Biochemistry

Harokopio University

研究点 (2)

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