Cardiovascular (CV) Risk, Nutrition, Cardiometabolic Health Indicators
Conditions
Keywords
Vegan, Vegetarian, Plant-based, Cardiometabolic health, Cardiometabolism, Cardiovascular health, Diet, Nutrition, Dietary Patterns, Nutrients
Brief summary
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.
Detailed description
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. Participants will self-report their dietary pattern as vegan (VGN), ovo-lacto-vegetarian (OLV), or omnivorous (OMNI). They will also indicate the estimated month and year of diet adoption and their main motivation (ethics, environment, health, taste, religion, spirituality, habit, or other). Dietary intake will be recorded for three days (two weekdays and one weekend day), and nutrient composition will be analyzed using MAR24 software, validated for the Argentine population. Fasting blood samples (12 hours) will be obtained to determine hematological, metabolic, and biochemical parameters. These include complete blood count, renal and liver function (urea, creatinine, AST, ALT, alkaline phosphatase, bilirubin, total proteins, albumin), lipid profile (total, HDL, and LDL cholesterol, triglycerides, apolipoprotein B), glucose and HbA1c, insulin (for HOMA-IR calculation), thyroid function (TSH), inflammation (high-sensitivity C-reactive protein), uric acid, vitamin B12, homocysteine, and iron status (serum iron, transferrin, percentage of transferrin saturation, and ferritin).
Interventions
Individuals reporting consumption of meat (including red meat, poultry, or fish), dairy products, and eggs less than once per month.
Individuals reporting consumption of meat (including red meat, poultry, or fish) less than once per month, with regular consumption of dairy products and/or eggs.
Individuals reporting regular consumption of meat (including red meat, poultry, or fish), dairy products, and/or eggs.
Sponsors
Study design
Eligibility
Inclusion criteria
* Adults aged 18 to 65 years. * Residence in the city of Rosario or surrounding areas. * Without major diseases. * BMI \>18.5 and \<30. * Adherence to a vegan, vegetarian, or omnivorous diet for at least 1 consecutive year at the time of recruitment.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition (Fat Mass and Lean Mass) | 12/2025 - 12/2027 | Total body fat mass and lean mass measured using bioelectrical impedance analysis (kg and %). |
| Uric Acid | 12/2025 - 12/2027 | Serum uric acid concentration (mg/dL) |
| Vitamin B12 | 12/2025 - 12/2027 | Serum vitamin B12 concentration (pg/mL) |
| Homocysteine | 12/2025 - 12/2027 | Plasma homocysteine concentration (µmol/L) |
| 25-hydroxy Vitamin D | 12/2025 - 12/2027 | Serum 25(OH)D concentration (ng/mL) |
| Serum Iron | 12/2025 - 12/2027 | Serum iron concentration (µg/dL) |
| Ferritin | 12/2025 - 12/2027 | Serum ferritin concentration(ng/mL) |
| Transferrin | 12/2025 - 12/2027 | Serum transferrin concentration(mg/dL) |
| Transferrin Saturation | 12/2025 - 12/2027 | Percentage of transferrin saturation calculated from serum iron and total iron-binding capacity (%) |
| Complete Blood Count (CBC) | 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 | 12/2025 - 12/2027 | Systolic and diastolic blood pressure measured in mmHg using a validated automated device. |
| Body Weight | 12/2025 - 12/2027 | Body weight measured in kilograms (kg) using a calibrated scale. |
| Body Mass Index (BMI) | 12/2025 - 12/2027 | BMI calculated as weight divided by height squared (kg/m²). |
| Waist Circumference | 12/2025 - 12/2027 | Waist circumference measured in centimeters (cm) at the midpoint between the last rib and the iliac crest. |
| Hip Circumference | 12/2025 - 12/2027 | Hip circumference measured in centimeters (cm) at the level of the greater trochanters. |
| Waist-to-Hip Ratio | 12/2025 - 12/2027 | Waist-to-hip ratio calculated as waist circumference divided by hip circumference (unitless). |
| Diet Composition | 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 | 12/2025 - 12/2027 | Serum total cholesterol concentration (mg/dl) |
| LDL-Cholesterol | 12/2025 - 12/2027 | Serum LDL cholesterol concentration calculated by Friedewald equation (mg/dl) |
| HDL-Cholesterol | 12/2025 - 12/2027 | Serum HDL-cholesterol concentration (mg/dl) |
| Triglycerides | 12/2025 - 12/2027 | Serum triglycerides concentration (mg/dl) |
| Fasting glucose | 12/2025 - 12/2027 | Serum fasting glucose concentration (mg/dl) |
| HbA1c | 12/2025 - 12/2027 | Glycated hemoglobin percentage (%) |
| Fasting Insulin | 12/2025 - 12/2027 | Serum fasting insulin concentration (µIU/mL) |
| HOMA-IR | 12/2025 - 12/2027 | Homeostatic Model Assessment of Insulin Resistance, calculated using fasting glucose and fasting insulin concentrations. |
| High-sensitivity C-reactive Protein | 12/2025 - 12/2027 | Serum High-sensitivity C-reactive Protein concentration (mg/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the current diet | 12/2025 - 12/2027 | D-Sat 28 Questionnaire |
| Physical activity levels and global quality of life | 12/2025 - 12/2027 | IPAQ and EQ5D-3L Questionnaires |
| Reasons for adopting dietary patterns | 12/2025 - 12/2027 | Ethics / animal rights, Environment, Health, Taste, Religion/Spirituality, Custom, Other (specify) |
| Alcohol and tobacco use | 12/2025 - 12/2027 | — |
| Serum Urea | 12/2025 - 12/2027 | Serum urea concentration (mg/dL). |
| Serum Creatinine | 12/2025 - 12/2027 | Serum creatinine concentration (mg/dL). |
| Alanine Aminotransferase (ALT/GPT) | 12/2025 - 12/2027 | Serum alanine aminotransferase concentration (U/L). |
| Aspartate Aminotransferase (AST/GOT) | 12/2025 - 12/2027 | Serum aspartate aminotransferase concentration (U/L). |
| Alkaline Phosphatase (ALP) | 12/2025 - 12/2027 | Serum alkaline phosphatase concentration (U/L). |
| Bilirubin | 12/2025 - 12/2027 | Serum total bilirubin concentration (mg/dL). |
| Total Protein | 12/2025 - 12/2027 | Serum total protein concentration (g/dL). |
| Thyroid-Stimulating Hormone (TSH) | 12/2025 - 12/2027 | Serum thyroid-stimulating hormone concentration (µIU/mL). |
| Grip Strength | 12/2025 - 12/2027 | Maximum voluntary isometric grip strength assessed with a calibrated hand dynamometer. The recorded value is the highest (kg) obtained from three valid attempts using the participant's dominant hand. |
| Supplement use | 12/2025 - 12/2027 | Type, dosing and if it was prescribed by a a health professional. |
Countries
Argentina