Effect of Eliminating Red Meat Consumption on the Cardiovascular System - A Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in Hematological Parameters - Haemoglobin
研究概览
简要总结
The objective of this clinical trial is to evaluate, in clinically healthy young omnivores, whether excluding red and processed meat from their diets for four weeks results in:
- measurable changes in arterial structure and function;
- measurable changes in key metabolic parameters.
The sample consisted of clinically healthy young people who had been following an omnivorous diet for at least one year. Those with a history that could influence the results were excluded. Exclusion criteria included alcohol or coffee abuse, vitamin B12 supplement intake, anemia, hypertension, cholesterol, diabetes, a history of cardiovascular disease, or an unstable clinical situation. Participants taking chronic medication, except those using oral contraceptives, were also excluded.
A single-group longitudinal study design is adopted, comprising a 4-week intervention period. Each participant undergoes two assessments: at baseline (T0) and 4 weeks after eliminating red/processed meat from the diet (T1). After being informed about the study and signing the informed consent form, participants are asked to complete a questionnaire containing information on sociodemographic (sex, age, weight, and height), behavioral (diet, smoking, alcohol consumption, coffee, vitamin B12 supplements, energy drinks, and sports activity), and clinical parameters (use of oral contraceptives, medications, anemia, hypertension, cholesterol, diabetes, and personal history of CVD). Participants are also instructed to replace red and processed meat in their daily diet with fish, eggs, or white meat, and to maintain the food proportions of their meals unchanged.
详细描述
Biochemical and Haematological parameters:
To determine blood parameters, 10 ml of peripheral blood was collected by venipuncture for serum and plasma in K3EDTA tubes. The biochemical profile was determined spectrophotometrically on a Prestige 24i chemistry analyzer (Tokyo Boeky, Tokyo, Japan) with reagents from Cormay® (Warsaw, Poland). Complete blood counts are performed on a Cell-Dyn Sapphire™ hematology analyzer (Abbott Laboratories, Santa Clara, CA, USA).
Approximately 7 mL of venous blood is collected per sample in a dry gel tube and centrifuged under vacuum at 1800 g, 4°C for 10 minutes. The serum is then separated into aliquots and stored at -20°C until the desired parameters are achieved. The analytical parameters total cholesterol, HDL-C, LDL-C, triglycerides, and glucose are obtained using the corresponding kit from Cormay, Poland. Concentrations are assessed spectrophotometrically according to the protocol and using the Prestige 24i equipment (TOKYO BOEKI MEDICAL SYSTEM LTD, Tokyo, Japan). The K3EDTA tube is used to perform complete blood counts on the Cell-Dyn Sapphire™ equipment (Abbott Laboratories, Santa Clara, CA, USA). All tests were validated and subjected to quality control.
Vascular parameters:
Participants are placed in the supine position and have a 5-minute rest period before data collection. Subsequently, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are measured. The cuff is placed on the right arm, aligned with the brachial artery, and adjusted to the arm circumference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy young people;
- •Young people who have followed an omnivorous diet for at least one year.
排除标准
- •Previous alcohol or coffee abuse;
- •Use of vitamin B12 supplements;
- •Unstable clinical status;
- •Individuals with anemia, hypertension, high cholesterol, diabetes, or a history of cardiovascular disease;
- •Chronic use of medications, except oral contraceptives.
结局指标
主要结局
Changes in Hematological Parameters - Haemoglobin
时间窗: 4 weeks
Changes in mean hemoglobin, measured in g/dL, from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Changes in Hematological Parameters - Reticulocytes
时间窗: 4 weeks
Changes in mean reticulocytes, measured in percentage, from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Changes in Biochemical Parameters
时间窗: 4 weeks
Changes in mean biochemical parameters, namely Total Cholesterol, Triglycerides, HDL-C (High Density Lipoprotein Cholesterol), LDL-C (Low Density Lipoprotein Cholesterol), and Glucose, measured in mg/dL, from baseline to 4 weeks after the exclusion of red and processed meat from the study participants' diets.
Changes in Vascular Parameters - Common Carotid Artery diameters
时间窗: 4 weeks
Changes in mean systolic and mean diastolic diameters of the common carotid artery, measured in millimeters, from baseline to 4 weeks after the exclusion of red and processed meat from the diet of study participants.
Changes in Vascular Parameters - Intima-Media Tickness
时间窗: 4 weeks
Changes in mean Intima-Media Tickness, measure in millimeters, from baseline to 4 weeks after the exclusion of red and processed meat from the diet of study participants.
Changes in Vascular Parameters - Compliance
时间窗: 4 weeks
Changes in mean compliance, measure in mm\^2. mm Hg\^( -1), from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Changes in Vascular Parameters - Common Carotid Artery Velocity
时间窗: 4 weeks
Changes in mean Peak Systolic velocity and Endodiastolic velocity of the common carotid artery, measured in cm/s, from baseline to 4 weeks after the exclusion of red and processed meat from the diet of study participants.
Changes in Vascular Parameters - Beta Stiffness index
时间窗: 4 weeks
Changes in mean common carotid artery beta stiffness index from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Changes in Vascular Parameters - Heart Rate
时间窗: 4 weeks
Changes in mean heart rate, measure in bpm, from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
次要结局
未报告次要终点
研究者
Maria Clara Rocha
Professor
Escola Superior de Tecnologia da Saúde de Coimbra