Comparative Analysis of Diet and Cardiometabolic Health in Individuals Following Vegan, Vegetarian, and Omnivorous Diets in the City of Rosario
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Diet Composition
研究概览
简要总结
The DiCaMeR study is an observational, cross-sectional study aimed at evaluating the relationship between dietary patterns and cardiometabolic health in adults. The study includes adults following vegan, vegetarian, and omnivorous diets residing in Rosario, Argentina. Participants undergo comprehensive assessments including dietary intake, anthropometric measurements, body composition, blood pressure, grip strenght, and laboratory biomarkers related to cardiovascular and metabolic health. The main objective is to compare diet characteristics and cardiometabolic risk profiles across different dietary patterns, providing insights into the potential health benefits and risks associated with each dietary pattern.
详细描述
This study will collect demographic, medical, dietary, and biochemical data to evaluate differences among vegan (VGN), ovo-lacto-vegetarian (OLV), and omnivorous (OMNI) participants. Demographic information will include age, sex, district of residence, marital status, number of children, occupation, health coverage (public, social security, or private), and highest educational level attained. Questions were adapted from the Argentine National Surveys of Households and Risk Factors.
Medical history will include current or past significant diseases, psychiatric conditions, reproductive status (premenopausal or menopausal), and habitual medication use. Participants taking drugs that may alter study outcomes (such as antihypertensives, lipid-lowering agents, or oral contraceptives) within the past 6 months will be excluded. Tobacco use will be classified as current, former, or never smoker. Information on supplement use and alcohol intake will also be collected. Alcohol consumption will be categorized as non-drinker, within recommended limits (up to one drink per day for women and two for men), or risk drinker (above these limits). Physical activity will be evaluated using the International Physical Activity Questionnaire (IPAQ) in it's short version, allowing classification into low, moderate, or high activity levels.
Self-perceived quality of life will be assessed with the EQ5D-3L questionnaire validated in Argentina, covering five health dimensions (mobility, self-care, daily activities, pain/discomfort, and anxiety/depression). Following national survey methodology, answers will be grouped into "no problem" or "some problem."
Dietary satisfaction will be evaluated using the DSat-28 questionnaire, which measures satisfaction in domains such as healthy lifestyle, eating out, cost, and food concerns. Higher scores indicate greater satisfaction.
Physical examination will include blood pressure measurement (validated automatic device), weight, height, and waist circumference according to WHO standards. Body composition will be assessed using bioelectrical impedance analysis (BIA), a validated method showing high correlation with DXA. Maximum voluntary isometric grip strength assessed with a calibrated hand dynamometer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 65 years.
- •Residence in the city of Rosario or surrounding areas.
- •Without major diseases.
- •BMI >18.5 and <
- •Adherence to a vegan, vegetarian, or omnivorous diet for at least 1 consecutive year at the time of recruitment.
排除标准
- •Acute or chronic diseases (cancer, infections, heart disease, or others), gastrointestinal disorders affecting diet, diabetes mellitus, chronic kidney or liver disease, or any other condition that could affect study outcomes.
- •Food allergies or intolerances that substantially affect the individual's usual diet.
- •Pregnant or breastfeeding women.
- •High-performance athletes (>15 hours per week of high-intensity physical activity).
- •Use of medications that could affect study outcomes, including antihypertensives, lipid-lowering drugs, hypoglycemic agents, glucocorticoids, and anti-obesity drugs. Note: vitamin, mineral, or other dietary supplements are not exclusion criteria.
- •Problematic use of alcohol or other drugs.
- •Simultaneous participation in another clinical trial.
- •Inability (physical or psychological) to perform the procedures required by this study.
- •Blood transfusions within the last 3 months.
结局指标
主要结局
Diet Composition
时间窗: 12/2025 - 12/2027
Descriptive and comparative analysis of vegan, vegetarian and omnivorous diets. Dietary intake estimation through validated questionnaires and tools to estimate nutrient composition.
Total Cholesterol
时间窗: 12/2025 - 12/2027
Serum total cholesterol concentration (mg/dl)
LDL-Cholesterol
时间窗: 12/2025 - 12/2027
Serum LDL cholesterol concentration calculated by Friedewald equation (mg/dl)
HDL-Cholesterol
时间窗: 12/2025 - 12/2027
Serum HDL-cholesterol concentration (mg/dl)
Triglycerides
时间窗: 12/2025 - 12/2027
Serum triglycerides concentration (mg/dl)
Fasting glucose
时间窗: 12/2025 - 12/2027
Serum fasting glucose concentration (mg/dl)
HbA1c
时间窗: 12/2025 - 12/2027
Glycated hemoglobin percentage (%)
Fasting Insulin
时间窗: 12/2025 - 12/2027
Serum fasting insulin concentration (µIU/mL)
HOMA-IR
时间窗: 12/2025 - 12/2027
Homeostatic Model Assessment of Insulin Resistance, calculated using fasting glucose and fasting insulin concentrations.
High-sensitivity C-reactive Protein
时间窗: 12/2025 - 12/2027
Serum High-sensitivity C-reactive Protein concentration (mg/L)
Uric Acid
时间窗: 12/2025 - 12/2027
Serum uric acid concentration (mg/dL)
Vitamin B12
时间窗: 12/2025 - 12/2027
Serum vitamin B12 concentration (pg/mL)
Homocysteine
时间窗: 12/2025 - 12/2027
Plasma homocysteine concentration (µmol/L)
25-hydroxy Vitamin D
时间窗: 12/2025 - 12/2027
Serum 25(OH)D concentration (ng/mL)
Serum Iron
时间窗: 12/2025 - 12/2027
Serum iron concentration (µg/dL)
Ferritin
时间窗: 12/2025 - 12/2027
Serum ferritin concentration(ng/mL)
Transferrin
时间窗: 12/2025 - 12/2027
Serum transferrin concentration(mg/dL)
Transferrin Saturation
时间窗: 12/2025 - 12/2027
Percentage of transferrin saturation calculated from serum iron and total iron-binding capacity (%)
Complete Blood Count (CBC)
时间窗: 12/2025 - 12/2027
Hemoglobin, hematocrit, red blood cell indices (MCV, MCH, MCHC), red blood cell count, white blood cell count (including differential), and platelet count as reported by the laboratory.
Blood Pressure
时间窗: 12/2025 - 12/2027
Systolic and diastolic blood pressure measured in mmHg using a validated automated device.
Body Weight
时间窗: 12/2025 - 12/2027
Body weight measured in kilograms (kg) using a calibrated scale.
Body Mass Index (BMI)
时间窗: 12/2025 - 12/2027
BMI calculated as weight divided by height squared (kg/m²).
Waist Circumference
时间窗: 12/2025 - 12/2027
Waist circumference measured in centimeters (cm) at the midpoint between the last rib and the iliac crest.
Hip Circumference
时间窗: 12/2025 - 12/2027
Hip circumference measured in centimeters (cm) at the level of the greater trochanters.
Waist-to-Hip Ratio
时间窗: 12/2025 - 12/2027
Waist-to-hip ratio calculated as waist circumference divided by hip circumference (unitless).
Body Composition (Fat Mass and Lean Mass)
时间窗: 12/2025 - 12/2027
Total body fat mass and lean mass measured using bioelectrical impedance analysis (kg and %).
次要结局
- Serum Creatinine(12/2025 - 12/2027)
- Supplement use(12/2025 - 12/2027)
- Satisfaction with the current diet(12/2025 - 12/2027)
- Physical activity levels and global quality of life(12/2025 - 12/2027)
- Reasons for adopting dietary patterns(12/2025 - 12/2027)
- Alcohol and tobacco use(12/2025 - 12/2027)
- Serum Urea(12/2025 - 12/2027)
- Alanine Aminotransferase (ALT/GPT)(12/2025 - 12/2027)
- Aspartate Aminotransferase (AST/GOT)(12/2025 - 12/2027)
- Alkaline Phosphatase (ALP)(12/2025 - 12/2027)
- Bilirubin(12/2025 - 12/2027)
- Total Protein(12/2025 - 12/2027)
- Thyroid-Stimulating Hormone (TSH)(12/2025 - 12/2027)
- Grip Strength(12/2025 - 12/2027)
研究者
Ariel Kraselnik
Medical Doctor, Professor
Universidad del Centro Educativo Latinoamericano