Diet and Cardiometabolism in Rosario

NCT07247487 | Recruiting

• 1 other identifier: NUT 817
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular (CV) Risk; Nutrition; Cardiometabolic Health Indicators

Keywords

Vegan; Vegetarian; Plant-based; Cardiometabolic health; Cardiometabolism; Cardiovascular health; Diet; Nutrition; Dietary Patterns; Nutrients

Outcome Measures

Primary Outcomes (26)

• 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 Outcomes (15)

• Supplement use

  12/2025 - 12/2027

• Satisfaction with the current diet

  12/2025 - 12/2027

• Physical activity levels and global quality of life

  12/2025 - 12/2027

• Reasons for adopting dietary patterns

  12/2025 - 12/2027

• Alcohol and tobacco use

  12/2025 - 12/2027

Study Arms (3)

Vegan

Consumption of meat (including red meat, poultry or fish), dairy products or eggs less than once per month.

Behavioral: Vegan diet

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

Omnivorous

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

Behavioral: Omnivorous diet

Interventions

Vegan diet BEHAVIORAL

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

Vegan

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.

Vegetarian

Omnivorous diet BEHAVIORAL

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

Omnivorous

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Universidad del Centro Educativo Latinoamericano: lead
• Universidad Nacional de Rosario: collaborator

Study Sites (2)

Consultorios Prisma

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Universidad del Centro Educativo Latinoamericano

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Related Links

• Official study website

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Interventions

Diet, Vegan; Diet, Vegetarian

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Ariel Kraselnik, MD

CONTACT

+54 9 11 5869 8996; akraselnik@ucel.edu.ar

Gabriela Giribaldi, RD

CONTACT

+54 9 341 609 5608; gabrielagiribaldi156@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

AR (2)