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NCT Number: NCT07247487

Diet and Cardiometabolism in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Consultorios Prisma, Rosario, Santa Fe Province, Argentina

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vegan diet

Behavioral

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

Vegetarian diet

Behavioral

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 diet

Behavioral

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

Primary outcomes

  1. Diet Composition

    Time frame: 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.

  2. Total Cholesterol

    Time frame: 12/2025 - 12/2027

    Serum total cholesterol concentration (mg/dl)

  3. LDL-Cholesterol

    Time frame: 12/2025 - 12/2027

    Serum LDL cholesterol concentration calculated by Friedewald equation (mg/dl)

  4. HDL-Cholesterol

    Time frame: 12/2025 - 12/2027

    Serum HDL-cholesterol concentration (mg/dl)

  5. Triglycerides

    Time frame: 12/2025 - 12/2027

    Serum triglycerides concentration (mg/dl)

  6. Fasting glucose

    Time frame: 12/2025 - 12/2027

    Serum fasting glucose concentration (mg/dl)

  7. HbA1c

    Time frame: 12/2025 - 12/2027

    Glycated hemoglobin percentage (%)

  8. Fasting Insulin

    Time frame: 12/2025 - 12/2027

    Serum fasting insulin concentration (µIU/mL)

  9. HOMA-IR

    Time frame: 12/2025 - 12/2027

    Homeostatic Model Assessment of Insulin Resistance, calculated using fasting glucose and fasting insulin concentrations.

  10. High-sensitivity C-reactive Protein

    Time frame: 12/2025 - 12/2027

    Serum High-sensitivity C-reactive Protein concentration (mg/L)

  11. Uric Acid

    Time frame: 12/2025 - 12/2027

    Serum uric acid concentration (mg/dL)

  12. Vitamin B12

    Time frame: 12/2025 - 12/2027

    Serum vitamin B12 concentration (pg/mL)

  13. Homocysteine

    Time frame: 12/2025 - 12/2027

    Plasma homocysteine concentration (µmol/L)

  14. 25-hydroxy Vitamin D

    Time frame: 12/2025 - 12/2027

    Serum 25(OH)D concentration (ng/mL)

  15. Serum Iron

    Time frame: 12/2025 - 12/2027

    Serum iron concentration (µg/dL)

  16. Ferritin

    Time frame: 12/2025 - 12/2027

    Serum ferritin concentration(ng/mL)

  17. Transferrin

    Time frame: 12/2025 - 12/2027

    Serum transferrin concentration(mg/dL)

  18. Transferrin Saturation

    Time frame: 12/2025 - 12/2027

    Percentage of transferrin saturation calculated from serum iron and total iron-binding capacity (%)

  19. Complete Blood Count (CBC)

    Time frame: 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.

  20. Blood Pressure

    Time frame: 12/2025 - 12/2027

    Systolic and diastolic blood pressure measured in mmHg using a validated automated device.

  21. Body Weight

    Time frame: 12/2025 - 12/2027

    Body weight measured in kilograms (kg) using a calibrated scale.

  22. Body Mass Index (BMI)

    Time frame: 12/2025 - 12/2027

    BMI calculated as weight divided by height squared (kg/m²).

  23. Waist Circumference

    Time frame: 12/2025 - 12/2027

    Waist circumference measured in centimeters (cm) at the midpoint between the last rib and the iliac crest.

  24. Hip Circumference

    Time frame: 12/2025 - 12/2027

    Hip circumference measured in centimeters (cm) at the level of the greater trochanters.

  25. Waist-to-Hip Ratio

    Time frame: 12/2025 - 12/2027

    Waist-to-hip ratio calculated as waist circumference divided by hip circumference (unitless).

  26. Body Composition (Fat Mass and Lean Mass)

    Time frame: 12/2025 - 12/2027

    Total body fat mass and lean mass measured using bioelectrical impedance analysis (kg and %).

Secondary outcomes

  1. Supplement use

    Time frame: 12/2025 - 12/2027

    Type, dosing and if it was prescribed by a a health professional.

  2. Satisfaction with the current diet

    Time frame: 12/2025 - 12/2027

    D-Sat 28 Questionnaire

  3. Physical activity levels and global quality of life

    Time frame: 12/2025 - 12/2027

    IPAQ and EQ5D-3L Questionnaires

  4. Reasons for adopting dietary patterns

    Time frame: 12/2025 - 12/2027

    Ethics / animal rights, Environment, Health, Taste, Religion/Spirituality, Custom, Other (specify)

  5. Alcohol and tobacco use

    Time frame: 12/2025 - 12/2027

  6. Serum Urea

    Time frame: 12/2025 - 12/2027

    Serum urea concentration (mg/dL).

  7. Serum Creatinine

    Time frame: 12/2025 - 12/2027

    Serum creatinine concentration (mg/dL).

  8. Alanine Aminotransferase (ALT/GPT)

    Time frame: 12/2025 - 12/2027

    Serum alanine aminotransferase concentration (U/L).

  9. Aspartate Aminotransferase (AST/GOT)

    Time frame: 12/2025 - 12/2027

    Serum aspartate aminotransferase concentration (U/L).

  10. Alkaline Phosphatase (ALP)

    Time frame: 12/2025 - 12/2027

    Serum alkaline phosphatase concentration (U/L).

  11. Bilirubin

    Time frame: 12/2025 - 12/2027

    Serum total bilirubin concentration (mg/dL).

  12. Bilirubin

    Time frame: 12/2025 - 12/2027

    Serum total and direct bilirubin concentration (mg/dL).

  13. Total Protein

    Time frame: 12/2025 - 12/2027

    Serum total protein concentration (g/dL).

  14. Thyroid-Stimulating Hormone (TSH)

    Time frame: 12/2025 - 12/2027

    Serum thyroid-stimulating hormone concentration (µIU/mL).

  15. Grip Strength

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel Kraselnik, MD

CONTACT

[email protected]

+54 9 11 5869 8996

Gabriela Giribaldi, RD

CONTACT

[email protected]

+54 9 341 609 5608

Sponsors and collaborators

Lead sponsor

Universidad del Centro Educativo Latinoamericano

Other

Collaborators

  • Universidad Nacional de Rosario

Registry information

Official study title

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

Acronym: DiCaMeR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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