Diet and Cardiometabolism in Rosario
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vegan diet, Vegetarian diet, Omnivorous diet.
- Who it may be relevant to
- Registry conditions: Cardiovascular (CV) Risk, Nutrition, Cardiometabolic Health Indicators. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparative Analysis of Diet and Cardiometabolic Health in Individuals Following Vegan, Vegetarian, and Omnivorous Diets in the City of Rosario
Overview
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
- Behavioral Vegan diet
Individuals reporting consumption of meat (including red meat, poultry, or fish), dairy products, and eggs less than once per month. - Behavioral Vegetarian diet
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. - Behavioral Omnivorous diet
Individuals reporting regular consumption of meat (including red meat, poultry, or fish), dairy products, and/or eggs.
Primary outcome measures
- Diet Composition [Time frame: 12/2025 - 12/2027]
- Total Cholesterol [Time frame: 12/2025 - 12/2027]
- LDL-Cholesterol [Time frame: 12/2025 - 12/2027]
- HDL-Cholesterol [Time frame: 12/2025 - 12/2027]
- Triglycerides [Time frame: 12/2025 - 12/2027]
- Fasting glucose [Time frame: 12/2025 - 12/2027]
- HbA1c [Time frame: 12/2025 - 12/2027]
- Fasting Insulin [Time frame: 12/2025 - 12/2027]
- HOMA-IR [Time frame: 12/2025 - 12/2027]
- High-sensitivity C-reactive Protein [Time frame: 12/2025 - 12/2027]
Secondary outcome measures (12)
- Supplement use [Time frame: 12/2025 - 12/2027]
- Satisfaction with the current diet [Time frame: 12/2025 - 12/2027]
- Physical activity levels and global quality of life [Time frame: 12/2025 - 12/2027]
- Reasons for adopting dietary patterns [Time frame: 12/2025 - 12/2027]
- Alcohol and tobacco use [Time frame: 12/2025 - 12/2027]
- Serum Urea [Time frame: 12/2025 - 12/2027]
- Serum Creatinine [Time frame: 12/2025 - 12/2027]
- Alanine Aminotransferase (ALT/GPT) [Time frame: 12/2025 - 12/2027]
- Aspartate Aminotransferase (AST/GOT) [Time frame: 12/2025 - 12/2027]
- Alkaline Phosphatase (ALP) [Time frame: 12/2025 - 12/2027]
- Bilirubin [Time frame: 12/2025 - 12/2027]
- Bilirubin [Time frame: 12/2025 - 12/2027]
Eligibility criteria
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Argentina · 2 centers
- Consultorios Prisma — Rosario
- Universidad del Centro Educativo Latinoamericano — Rosario
Identifiers
NCT: NCT07247487 · NUT 817