Vegan diet
BehavioralIndividuals reporting consumption of meat (including red meat, poultry, or fish), dairy products, and eggs less than once per month.
NCT Number: NCT07247487
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Consultorios Prisma, Rosario, Santa Fe Province, Argentina
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals reporting consumption of meat (including red meat, poultry, or fish), dairy products, and eggs less than once per month.
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.
Individuals reporting regular consumption of meat (including red meat, poultry, or fish), dairy products, and/or eggs.
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.
Time frame: 12/2025 - 12/2027
Serum total cholesterol concentration (mg/dl)
Time frame: 12/2025 - 12/2027
Serum LDL cholesterol concentration calculated by Friedewald equation (mg/dl)
Time frame: 12/2025 - 12/2027
Serum HDL-cholesterol concentration (mg/dl)
Time frame: 12/2025 - 12/2027
Serum triglycerides concentration (mg/dl)
Time frame: 12/2025 - 12/2027
Serum fasting glucose concentration (mg/dl)
Time frame: 12/2025 - 12/2027
Glycated hemoglobin percentage (%)
Time frame: 12/2025 - 12/2027
Serum fasting insulin concentration (µIU/mL)
Time frame: 12/2025 - 12/2027
Homeostatic Model Assessment of Insulin Resistance, calculated using fasting glucose and fasting insulin concentrations.
Time frame: 12/2025 - 12/2027
Serum High-sensitivity C-reactive Protein concentration (mg/L)
Time frame: 12/2025 - 12/2027
Serum uric acid concentration (mg/dL)
Time frame: 12/2025 - 12/2027
Serum vitamin B12 concentration (pg/mL)
Time frame: 12/2025 - 12/2027
Plasma homocysteine concentration (µmol/L)
Time frame: 12/2025 - 12/2027
Serum 25(OH)D concentration (ng/mL)
Time frame: 12/2025 - 12/2027
Serum iron concentration (µg/dL)
Time frame: 12/2025 - 12/2027
Serum ferritin concentration(ng/mL)
Time frame: 12/2025 - 12/2027
Serum transferrin concentration(mg/dL)
Time frame: 12/2025 - 12/2027
Percentage of transferrin saturation calculated from serum iron and total iron-binding capacity (%)
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.
Time frame: 12/2025 - 12/2027
Systolic and diastolic blood pressure measured in mmHg using a validated automated device.
Time frame: 12/2025 - 12/2027
Body weight measured in kilograms (kg) using a calibrated scale.
Time frame: 12/2025 - 12/2027
BMI calculated as weight divided by height squared (kg/m²).
Time frame: 12/2025 - 12/2027
Waist circumference measured in centimeters (cm) at the midpoint between the last rib and the iliac crest.
Time frame: 12/2025 - 12/2027
Hip circumference measured in centimeters (cm) at the level of the greater trochanters.
Time frame: 12/2025 - 12/2027
Waist-to-hip ratio calculated as waist circumference divided by hip circumference (unitless).
Time frame: 12/2025 - 12/2027
Total body fat mass and lean mass measured using bioelectrical impedance analysis (kg and %).
Time frame: 12/2025 - 12/2027
Type, dosing and if it was prescribed by a a health professional.
Time frame: 12/2025 - 12/2027
D-Sat 28 Questionnaire
Time frame: 12/2025 - 12/2027
IPAQ and EQ5D-3L Questionnaires
Time frame: 12/2025 - 12/2027
Ethics / animal rights, Environment, Health, Taste, Religion/Spirituality, Custom, Other (specify)
Time frame: 12/2025 - 12/2027
Time frame: 12/2025 - 12/2027
Serum urea concentration (mg/dL).
Time frame: 12/2025 - 12/2027
Serum creatinine concentration (mg/dL).
Time frame: 12/2025 - 12/2027
Serum alanine aminotransferase concentration (U/L).
Time frame: 12/2025 - 12/2027
Serum aspartate aminotransferase concentration (U/L).
Time frame: 12/2025 - 12/2027
Serum alkaline phosphatase concentration (U/L).
Time frame: 12/2025 - 12/2027
Serum total bilirubin concentration (mg/dL).
Time frame: 12/2025 - 12/2027
Serum total and direct bilirubin concentration (mg/dL).
Time frame: 12/2025 - 12/2027
Serum total protein concentration (g/dL).
Time frame: 12/2025 - 12/2027
Serum thyroid-stimulating hormone concentration (µIU/mL).
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.
Contact information is provided by the study sponsor or research team.
Ariel Kraselnik, MD
CONTACT
Gabriela Giribaldi, RD
CONTACT
Universidad del Centro Educativo Latinoamericano
Other
Comparative Analysis of Diet and Cardiometabolic Health in Individuals Following Vegan, Vegetarian, and Omnivorous Diets in the City of Rosario
Acronym: DiCaMeR
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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