Diet and Cardiometabolism in Rosario (DiCaMeR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition; Cardiovascular (CV) Risk; Cardiometabolic Health Indicators
• Intervention / Treatment: Behavioral: Vegan diet; Behavioral: Vegetarian diet; Behavioral: Omnivorous diet

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).

• Study Type: Observational
• Enrollment (Estimated): 105

Contacts and Locations

• Study Contact: Name: Ariel Kraselnik, MD; Phone Number: +54 9 11 5869 8996; Email: akraselnik@ucel.edu.ar
• Study Contact Backup: Name: Gabriela Giribaldi, RD; Phone Number: +54 9 341 609 5608; Email: gabrielagiribaldi156@gmail.com

Study Locations

• Argentina
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Recruiting
      • Consultorios Prisma
      • Contact: Ariel Kraselnik, MD; Phone Number: +54 9 11 58698996; Email: akraselnik@ucel.edu.ar
    • Rosario, Santa Fe Province, Argentina, 2000
      • Recruiting
      • Universidad del Centro Educativo Latinoamericano
      • Contact: Gabriel Frontons; Phone Number: +54 0341 449-9292; Email: gfrontons@ucel.edu.ar
      • Contact: Gabriela Giribaldi, RD; Phone Number: +54 9 341 609 5608; Email: ggiribaldi@ucel.edu.ar
      • Principal Investigator: Ariel Kraselnik, MD
      • Sub-Investigator: Gabriela Giribaldi, RD
      • Sub-Investigator: Patricia Torres, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-65 years from Rosario, Argentina, following a vegan, vegetarian, or omnivorous diet for ≥1 year. Generally healthy, BMI 18.5-30. Excludes pregnant or breastfeeding women, high-performance athletes, individuals with major diseases, problematic alcohol or drug use, recent blood transfusions, or those unable to complete study procedures.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vegan; Consumption of meat (including red meat, poultry or fish), dairy products or eggs less than once per month.	Behavioral: Vegan diet; Individuals reporting consumption of meat (including red meat, poultry, or fish), dairy products, and eggs less than once per month.
Vegetarian; Consumption of meat (including red meat, poultry, or fish) less than once per month, with regular consumption of dairy products and/or eggs.	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.
Omnivorous; Regular consumption of meat (including red meat, poultry or fish), 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet Composition	Descriptive and comparative analysis of vegan, vegetarian and omnivorous diets. Dietary intake estimation through validated questionnaires and tools to estimate nutrient composition.	12/2025 - 12/2027
Total Cholesterol	Serum total cholesterol concentration (mg/dl)	12/2025 - 12/2027
LDL-Cholesterol	Serum LDL cholesterol concentration calculated by Friedewald equation (mg/dl)	12/2025 - 12/2027
HDL-Cholesterol	Serum HDL-cholesterol concentration (mg/dl)	12/2025 - 12/2027
Triglycerides	Serum triglycerides concentration (mg/dl)	12/2025 - 12/2027
Fasting glucose	Serum fasting glucose concentration (mg/dl)	12/2025 - 12/2027
HbA1c	Glycated hemoglobin percentage (%)	12/2025 - 12/2027
Fasting Insulin	Serum fasting insulin concentration (µIU/mL)	12/2025 - 12/2027
HOMA-IR	Homeostatic Model Assessment of Insulin Resistance, calculated using fasting glucose and fasting insulin concentrations.	12/2025 - 12/2027
High-sensitivity C-reactive Protein	Serum High-sensitivity C-reactive Protein concentration (mg/L)	12/2025 - 12/2027
Uric Acid	Serum uric acid concentration (mg/dL)	12/2025 - 12/2027
Vitamin B12	Serum vitamin B12 concentration (pg/mL)	12/2025 - 12/2027
Homocysteine	Plasma homocysteine concentration (µmol/L)	12/2025 - 12/2027
25-hydroxy Vitamin D	Serum 25(OH)D concentration (ng/mL)	12/2025 - 12/2027
Serum Iron	Serum iron concentration (µg/dL)	12/2025 - 12/2027
Ferritin	Serum ferritin concentration(ng/mL)	12/2025 - 12/2027
Transferrin	Serum transferrin concentration(mg/dL)	12/2025 - 12/2027
Transferrin Saturation	Percentage of transferrin saturation calculated from serum iron and total iron-binding capacity (%)	12/2025 - 12/2027
Complete Blood Count (CBC)	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.	12/2025 - 12/2027
Blood Pressure	Systolic and diastolic blood pressure measured in mmHg using a validated automated device.	12/2025 - 12/2027
Body Weight	Body weight measured in kilograms (kg) using a calibrated scale.	12/2025 - 12/2027
Body Mass Index (BMI)	BMI calculated as weight divided by height squared (kg/m²).	12/2025 - 12/2027
Waist Circumference	Waist circumference measured in centimeters (cm) at the midpoint between the last rib and the iliac crest.	12/2025 - 12/2027
Hip Circumference	Hip circumference measured in centimeters (cm) at the level of the greater trochanters.	12/2025 - 12/2027
Waist-to-Hip Ratio	Waist-to-hip ratio calculated as waist circumference divided by hip circumference (unitless).	12/2025 - 12/2027
Body Composition (Fat Mass and Lean Mass)	Total body fat mass and lean mass measured using bioelectrical impedance analysis (kg and %).	12/2025 - 12/2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supplement use	Type, dosing and if it was prescribed by a a health professional.	12/2025 - 12/2027
Satisfaction with the current diet	D-Sat 28 Questionnaire	12/2025 - 12/2027
Physical activity levels and global quality of life	IPAQ and EQ5D-3L Questionnaires	12/2025 - 12/2027
Reasons for adopting dietary patterns	Ethics / animal rights, Environment, Health, Taste, Religion/Spirituality, Custom, Other (specify)	12/2025 - 12/2027
Alcohol and tobacco use		12/2025 - 12/2027
Serum Urea	Serum urea concentration (mg/dL).	12/2025 - 12/2027
Serum Creatinine	Serum creatinine concentration (mg/dL).	12/2025 - 12/2027
Alanine Aminotransferase (ALT/GPT)	Serum alanine aminotransferase concentration (U/L).	12/2025 - 12/2027
Aspartate Aminotransferase (AST/GOT)	Serum aspartate aminotransferase concentration (U/L).	12/2025 - 12/2027
Alkaline Phosphatase (ALP)	Serum alkaline phosphatase concentration (U/L).	12/2025 - 12/2027
Bilirubin	Serum total bilirubin concentration (mg/dL).	12/2025 - 12/2027
Bilirubin	Serum total and direct bilirubin concentration (mg/dL).	12/2025 - 12/2027
Total Protein	Serum total protein concentration (g/dL).	12/2025 - 12/2027
Thyroid-Stimulating Hormone (TSH)	Serum thyroid-stimulating hormone concentration (µIU/mL).	12/2025 - 12/2027
Grip Strength	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.	12/2025 - 12/2027

Collaborators and Investigators

• Sponsor: Universidad del Centro Educativo Latinoamericano
• Collaborators: Universidad Nacional de Rosario

Publications and helpful links

Helpful Links

• Official study website

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): November 25, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Nutrition; Diet; Vegan; Dietary Patterns; Cardiovascular health; Vegetarian; Cardiometabolic health; Plant-based; Nutrients; Cardiometabolism
• Additional Relevant MeSH Terms: Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Vegetarian; Diet, Vegan
• Other Study ID Numbers: NUT 817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data available under request for research purposes, and after evaluation by the investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No