Skip to content

Diet and Cardiometabolism in Rosario

Comparative Analysis of Diet and Cardiometabolic Health in Individuals Following Vegan, Vegetarian, and Omnivorous Diets in the City of Rosario

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07247487
Acronym
DiCaMeR
Enrollment
105
Registered
2025-11-25
Start date
2025-12-01
Completion date
2027-12-01
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular (CV) Risk, Nutrition, Cardiometabolic Health Indicators

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

BEHAVIORALVegan diet

Individuals reporting consumption of meat (including red meat, poultry, or fish), dairy products, and eggs less than once per month.

BEHAVIORALVegetarian 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.

BEHAVIORALOmnivorous diet

Individuals reporting regular consumption of meat (including red meat, poultry, or fish), dairy products, and/or eggs.

Sponsors

Universidad Nacional de Rosario
CollaboratorOTHER
Universidad del Centro Educativo Latinoamericano
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Body Composition (Fat Mass and Lean Mass)12/2025 - 12/2027Total body fat mass and lean mass measured using bioelectrical impedance analysis (kg and %).
Uric Acid12/2025 - 12/2027Serum uric acid concentration (mg/dL)
Vitamin B1212/2025 - 12/2027Serum vitamin B12 concentration (pg/mL)
Homocysteine12/2025 - 12/2027Plasma homocysteine concentration (µmol/L)
25-hydroxy Vitamin D12/2025 - 12/2027Serum 25(OH)D concentration (ng/mL)
Serum Iron12/2025 - 12/2027Serum iron concentration (µg/dL)
Ferritin12/2025 - 12/2027Serum ferritin concentration(ng/mL)
Transferrin12/2025 - 12/2027Serum transferrin concentration(mg/dL)
Transferrin Saturation12/2025 - 12/2027Percentage of transferrin saturation calculated from serum iron and total iron-binding capacity (%)
Complete Blood Count (CBC)12/2025 - 12/2027Hemoglobin, 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 Pressure12/2025 - 12/2027Systolic and diastolic blood pressure measured in mmHg using a validated automated device.
Body Weight12/2025 - 12/2027Body weight measured in kilograms (kg) using a calibrated scale.
Body Mass Index (BMI)12/2025 - 12/2027BMI calculated as weight divided by height squared (kg/m²).
Waist Circumference12/2025 - 12/2027Waist circumference measured in centimeters (cm) at the midpoint between the last rib and the iliac crest.
Hip Circumference12/2025 - 12/2027Hip circumference measured in centimeters (cm) at the level of the greater trochanters.
Waist-to-Hip Ratio12/2025 - 12/2027Waist-to-hip ratio calculated as waist circumference divided by hip circumference (unitless).
Diet Composition12/2025 - 12/2027Descriptive and comparative analysis of vegan, vegetarian and omnivorous diets. Dietary intake estimation through validated questionnaires and tools to estimate nutrient composition.
Total Cholesterol12/2025 - 12/2027Serum total cholesterol concentration (mg/dl)
LDL-Cholesterol12/2025 - 12/2027Serum LDL cholesterol concentration calculated by Friedewald equation (mg/dl)
HDL-Cholesterol12/2025 - 12/2027Serum HDL-cholesterol concentration (mg/dl)
Triglycerides12/2025 - 12/2027Serum triglycerides concentration (mg/dl)
Fasting glucose12/2025 - 12/2027Serum fasting glucose concentration (mg/dl)
HbA1c12/2025 - 12/2027Glycated hemoglobin percentage (%)
Fasting Insulin12/2025 - 12/2027Serum fasting insulin concentration (µIU/mL)
HOMA-IR12/2025 - 12/2027Homeostatic Model Assessment of Insulin Resistance, calculated using fasting glucose and fasting insulin concentrations.
High-sensitivity C-reactive Protein12/2025 - 12/2027Serum High-sensitivity C-reactive Protein concentration (mg/L)

Secondary

MeasureTime frameDescription
Satisfaction with the current diet12/2025 - 12/2027D-Sat 28 Questionnaire
Physical activity levels and global quality of life12/2025 - 12/2027IPAQ and EQ5D-3L Questionnaires
Reasons for adopting dietary patterns12/2025 - 12/2027Ethics / animal rights, Environment, Health, Taste, Religion/Spirituality, Custom, Other (specify)
Alcohol and tobacco use12/2025 - 12/2027
Serum Urea12/2025 - 12/2027Serum urea concentration (mg/dL).
Serum Creatinine12/2025 - 12/2027Serum creatinine concentration (mg/dL).
Alanine Aminotransferase (ALT/GPT)12/2025 - 12/2027Serum alanine aminotransferase concentration (U/L).
Aspartate Aminotransferase (AST/GOT)12/2025 - 12/2027Serum aspartate aminotransferase concentration (U/L).
Alkaline Phosphatase (ALP)12/2025 - 12/2027Serum alkaline phosphatase concentration (U/L).
Bilirubin12/2025 - 12/2027Serum total bilirubin concentration (mg/dL).
Total Protein12/2025 - 12/2027Serum total protein concentration (g/dL).
Thyroid-Stimulating Hormone (TSH)12/2025 - 12/2027Serum thyroid-stimulating hormone concentration (µIU/mL).
Grip Strength12/2025 - 12/2027Maximum 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 use12/2025 - 12/2027Type, dosing and if it was prescribed by a a health professional.

Countries

Argentina

Contacts

Primary ContactAriel Kraselnik, MD
akraselnik@ucel.edu.ar+54 9 11 5869 8996
Backup ContactGabriela Giribaldi, RD
gabrielagiribaldi156@gmail.com+54 9 341 609 5608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026