Diet and Cardiometabolism in Rosario (DiCaMeR)

November 25, 2025 updated by: Ariel Kraselnik, Universidad del Centro Educativo Latinoamericano

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Consultorios Prisma
        • Contact:
      • Rosario, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Universidad del Centro Educativo Latinoamericano
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ariel Kraselnik, MD
        • Sub-Investigator:
          • Gabriela Giribaldi, RD
        • Sub-Investigator:
          • Patricia Torres, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12/2025 - 12/2027
Total Cholesterol
Time Frame: 12/2025 - 12/2027
Serum total cholesterol concentration (mg/dl)
12/2025 - 12/2027
LDL-Cholesterol
Time Frame: 12/2025 - 12/2027
Serum LDL cholesterol concentration calculated by Friedewald equation (mg/dl)
12/2025 - 12/2027
HDL-Cholesterol
Time Frame: 12/2025 - 12/2027
Serum HDL-cholesterol concentration (mg/dl)
12/2025 - 12/2027
Triglycerides
Time Frame: 12/2025 - 12/2027
Serum triglycerides concentration (mg/dl)
12/2025 - 12/2027
Fasting glucose
Time Frame: 12/2025 - 12/2027
Serum fasting glucose concentration (mg/dl)
12/2025 - 12/2027
HbA1c
Time Frame: 12/2025 - 12/2027
Glycated hemoglobin percentage (%)
12/2025 - 12/2027
Fasting Insulin
Time Frame: 12/2025 - 12/2027
Serum fasting insulin concentration (µIU/mL)
12/2025 - 12/2027
HOMA-IR
Time Frame: 12/2025 - 12/2027
Homeostatic Model Assessment of Insulin Resistance, calculated using fasting glucose and fasting insulin concentrations.
12/2025 - 12/2027
High-sensitivity C-reactive Protein
Time Frame: 12/2025 - 12/2027
Serum High-sensitivity C-reactive Protein concentration (mg/L)
12/2025 - 12/2027
Uric Acid
Time Frame: 12/2025 - 12/2027
Serum uric acid concentration (mg/dL)
12/2025 - 12/2027
Vitamin B12
Time Frame: 12/2025 - 12/2027
Serum vitamin B12 concentration (pg/mL)
12/2025 - 12/2027
Homocysteine
Time Frame: 12/2025 - 12/2027
Plasma homocysteine concentration (µmol/L)
12/2025 - 12/2027
25-hydroxy Vitamin D
Time Frame: 12/2025 - 12/2027
Serum 25(OH)D concentration (ng/mL)
12/2025 - 12/2027
Serum Iron
Time Frame: 12/2025 - 12/2027
Serum iron concentration (µg/dL)
12/2025 - 12/2027
Ferritin
Time Frame: 12/2025 - 12/2027
Serum ferritin concentration(ng/mL)
12/2025 - 12/2027
Transferrin
Time Frame: 12/2025 - 12/2027
Serum transferrin concentration(mg/dL)
12/2025 - 12/2027
Transferrin Saturation
Time Frame: 12/2025 - 12/2027
Percentage of transferrin saturation calculated from serum iron and total iron-binding capacity (%)
12/2025 - 12/2027
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.
12/2025 - 12/2027
Blood Pressure
Time Frame: 12/2025 - 12/2027
Systolic and diastolic blood pressure measured in mmHg using a validated automated device.
12/2025 - 12/2027
Body Weight
Time Frame: 12/2025 - 12/2027
Body weight measured in kilograms (kg) using a calibrated scale.
12/2025 - 12/2027
Body Mass Index (BMI)
Time Frame: 12/2025 - 12/2027
BMI calculated as weight divided by height squared (kg/m²).
12/2025 - 12/2027
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.
12/2025 - 12/2027
Hip Circumference
Time Frame: 12/2025 - 12/2027
Hip circumference measured in centimeters (cm) at the level of the greater trochanters.
12/2025 - 12/2027
Waist-to-Hip Ratio
Time Frame: 12/2025 - 12/2027
Waist-to-hip ratio calculated as waist circumference divided by hip circumference (unitless).
12/2025 - 12/2027
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 %).
12/2025 - 12/2027

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Supplement use
Time Frame: 12/2025 - 12/2027
Type, dosing and if it was prescribed by a a health professional.
12/2025 - 12/2027
Satisfaction with the current diet
Time Frame: 12/2025 - 12/2027
D-Sat 28 Questionnaire
12/2025 - 12/2027
Physical activity levels and global quality of life
Time Frame: 12/2025 - 12/2027
IPAQ and EQ5D-3L Questionnaires
12/2025 - 12/2027
Reasons for adopting dietary patterns
Time Frame: 12/2025 - 12/2027
Ethics / animal rights, Environment, Health, Taste, Religion/Spirituality, Custom, Other (specify)
12/2025 - 12/2027
Alcohol and tobacco use
Time Frame: 12/2025 - 12/2027
12/2025 - 12/2027
Serum Urea
Time Frame: 12/2025 - 12/2027
Serum urea concentration (mg/dL).
12/2025 - 12/2027
Serum Creatinine
Time Frame: 12/2025 - 12/2027
Serum creatinine concentration (mg/dL).
12/2025 - 12/2027
Alanine Aminotransferase (ALT/GPT)
Time Frame: 12/2025 - 12/2027
Serum alanine aminotransferase concentration (U/L).
12/2025 - 12/2027
Aspartate Aminotransferase (AST/GOT)
Time Frame: 12/2025 - 12/2027
Serum aspartate aminotransferase concentration (U/L).
12/2025 - 12/2027
Alkaline Phosphatase (ALP)
Time Frame: 12/2025 - 12/2027
Serum alkaline phosphatase concentration (U/L).
12/2025 - 12/2027
Bilirubin
Time Frame: 12/2025 - 12/2027
Serum total bilirubin concentration (mg/dL).
12/2025 - 12/2027
Bilirubin
Time Frame: 12/2025 - 12/2027
Serum total and direct bilirubin concentration (mg/dL).
12/2025 - 12/2027
Total Protein
Time Frame: 12/2025 - 12/2027
Serum total protein concentration (g/dL).
12/2025 - 12/2027
Thyroid-Stimulating Hormone (TSH)
Time Frame: 12/2025 - 12/2027
Serum thyroid-stimulating hormone concentration (µIU/mL).
12/2025 - 12/2027
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.
12/2025 - 12/2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad del Centro Educativo Latinoamericano

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Nacional de Rosario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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