Cardiovascular (CV) RiskDiCaMeRNCT07247487
Diet and Cardiometabolism in Rosario
An observational study of Cardiovascular (CV) Risk and Nutrition, run by Universidad del Centro Educativo Latinoamericano at 2 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular (CV) Risk, Nutrition, Cardiometabolic Health Indicators
- What is being tested?
- Vegan diet, Vegetarian diet and Omnivorous diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 105 participants
- Where
- 2 sitesArgentina
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina2 sites, 2 recruiting
- Recruiting
Consultorios Prisma
Rosario, Santa Fe Province, 2000
Ariel Kraselnik, MD, +54 9 11 58698996, akraselnik@ucel.edu.ar
- Recruiting
Universidad del Centro Educativo Latinoamericano
Rosario, Santa Fe Province, 2000
Gabriel Frontons, +54 0341 449-9292, gfrontons@ucel.edu.ar
Gabriela Giribaldi, RD, +54 9 341 609 5608, ggiribaldi@ucel.edu.ar
About this study
Official title: 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.
Read the 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).
- Being tested
- Vegan diet, Vegetarian diet, Omnivorous diet
- Keywords
- Vegan, Vegetarian, Plant-based, Cardiometabolic health, Cardiometabolism, Cardiovascular health, Diet, Nutrition, Dietary Patterns, Nutrients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan dietBehavioural
Individuals reporting consumption of meat (including red meat, poultry, or fish), dairy products, and eggs less than once per month.
Vegetarian dietBehavioural
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 dietBehavioural
Individuals reporting regular consumption of meat (including red meat, poultry, or fish), dairy products, and/or eggs.
| Study group | Role | What they receive |
|---|---|---|
| Vegan | Consumption of meat (including red meat, poultry or fish), dairy products or eggs less than once per month. Receives: 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. Receives: Behavioral: Vegetarian diet | |
| Omnivorous | Regular consumption of meat (including red meat, poultry or fish), dairy products, and/or eggs. Receives: Behavioral: Omnivorous diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Composition
Descriptive and comparative analysis of vegan, vegetarian and omnivorous diets. Dietary intake estimation through validated questionnaires and tools to estimate nutrient composition.
Measured: 12/2025 - 12/2027
Total Cholesterol
Serum total cholesterol concentration (mg/dl)
Measured: 12/2025 - 12/2027
LDL-Cholesterol
Serum LDL cholesterol concentration calculated by Friedewald equation (mg/dl)
Measured: 12/2025 - 12/2027
HDL-Cholesterol
Serum HDL-cholesterol concentration (mg/dl)
Measured: 12/2025 - 12/2027
Triglycerides
Serum triglycerides concentration (mg/dl)
Measured: 12/2025 - 12/2027
Fasting glucose
Serum fasting glucose concentration (mg/dl)
Measured: 12/2025 - 12/2027
HbA1c
Glycated hemoglobin percentage (%)
Measured: 12/2025 - 12/2027
Fasting Insulin
Serum fasting insulin concentration (µIU/mL)
Measured: 12/2025 - 12/2027
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance, calculated using fasting glucose and fasting insulin concentrations.
Measured: 12/2025 - 12/2027
High-sensitivity C-reactive Protein
Serum High-sensitivity C-reactive Protein concentration (mg/L)
Measured: 12/2025 - 12/2027
Uric Acid
Serum uric acid concentration (mg/dL)
Measured: 12/2025 - 12/2027
Vitamin B12
Serum vitamin B12 concentration (pg/mL)
Measured: 12/2025 - 12/2027
Homocysteine
Plasma homocysteine concentration (µmol/L)
Measured: 12/2025 - 12/2027
25-hydroxy Vitamin D
Serum 25(OH)D concentration (ng/mL)
Measured: 12/2025 - 12/2027
Serum Iron
Serum iron concentration (µg/dL)
Measured: 12/2025 - 12/2027
Ferritin
Serum ferritin concentration(ng/mL)
Measured: 12/2025 - 12/2027
Transferrin
Serum transferrin concentration(mg/dL)
Measured: 12/2025 - 12/2027
Transferrin Saturation
Percentage of transferrin saturation calculated from serum iron and total iron-binding capacity (%)
Measured: 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.
Measured: 12/2025 - 12/2027
Blood Pressure
Systolic and diastolic blood pressure measured in mmHg using a validated automated device.
Measured: 12/2025 - 12/2027
Body Weight
Body weight measured in kilograms (kg) using a calibrated scale.
Measured: 12/2025 - 12/2027
Body Mass Index (BMI)
BMI calculated as weight divided by height squared (kg/m²).
Measured: 12/2025 - 12/2027
Waist Circumference
Waist circumference measured in centimeters (cm) at the midpoint between the last rib and the iliac crest.
Measured: 12/2025 - 12/2027
Hip Circumference
Hip circumference measured in centimeters (cm) at the level of the greater trochanters.
Measured: 12/2025 - 12/2027
Waist-to-Hip Ratio
Waist-to-hip ratio calculated as waist circumference divided by hip circumference (unitless).
Measured: 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 %).
Measured: 12/2025 - 12/2027
Secondary outcomes (15)
Supplement use
Type, dosing and if it was prescribed by a a health professional.
Measured: 12/2025 - 12/2027
Satisfaction with the current diet
D-Sat 28 Questionnaire
Measured: 12/2025 - 12/2027
Physical activity levels and global quality of life
IPAQ and EQ5D-3L Questionnaires
Measured: 12/2025 - 12/2027
Reasons for adopting dietary patterns
Ethics / animal rights, Environment, Health, Taste, Religion/Spirituality, Custom, Other (specify)
Measured: 12/2025 - 12/2027
Alcohol and tobacco use
Measured: 12/2025 - 12/2027
Serum Urea
Serum urea concentration (mg/dL).
Measured: 12/2025 - 12/2027
Serum Creatinine
Serum creatinine concentration (mg/dL).
Measured: 12/2025 - 12/2027
Alanine Aminotransferase (ALT/GPT)
Serum alanine aminotransferase concentration (U/L).
Measured: 12/2025 - 12/2027
Aspartate Aminotransferase (AST/GOT)
Serum aspartate aminotransferase concentration (U/L).
Measured: 12/2025 - 12/2027
Alkaline Phosphatase (ALP)
Serum alkaline phosphatase concentration (U/L).
Measured: 12/2025 - 12/2027
Bilirubin
Serum total bilirubin concentration (mg/dL).
Measured: 12/2025 - 12/2027
Bilirubin
Serum total and direct bilirubin concentration (mg/dL).
Measured: 12/2025 - 12/2027
Total Protein
Serum total protein concentration (g/dL).
Measured: 12/2025 - 12/2027
Thyroid-Stimulating Hormone (TSH)
Serum thyroid-stimulating hormone concentration (µIU/mL).
Measured: 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.
Measured: 12/2025 - 12/2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular (CV) RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad del Centro Educativo Latinoamericano
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional de Rosario
- Responsible party
- Principal investigator, Ariel Kraselnik, Universidad del Centro Educativo Latinoamericano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247487
- Sponsor's protocol ID
- NUT 817
- Acronym
- DiCaMeR
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available under request for research purposes, and after evaluation by the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Diet and Cardiometabolic Health in Individuals Following Vegan, Vegetarian, and Omnivorous Diets in the City of Rosario
- ClinicalTrials.gov ID
- NCT07247487
- Acronym / sponsor ID
- DiCaMeR / NUT 817
- Keywords
- Vegan, Vegetarian, Plant-based, Cardiometabolic health, Cardiometabolism, Cardiovascular health, Diet, Nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Universidad del Centro Educativo LatinoamericanoUniversity, hospital or other
- Collaborators
- Universidad Nacional de Rosario
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegan | – | Behavioral: Vegan dietConsumption of meat (including red meat, poultry or fish), dairy products or eggs less than once per month. |
| Vegetarian | – | Behavioral: Vegetarian dietConsumption of meat (including red meat, poultry, or fish) less than once per month, with regular consumption of dairy products and/or eggs. |
| Omnivorous | – | Behavioral: Omnivorous dietRegular consumption of meat (including red meat, poultry or fish), dairy products, and/or eggs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegan dietIndividuals reporting consumption of meat (including red meat, poultry, or fish), dairy products, and eggs less than once per month. | Behavioural | Vegan |
| Vegetarian dietIndividuals reporting consumption of meat (including red meat, poultry, or fish) less than once per month, with regular consumption of dairy products and/or eggs. | Behavioural | Vegetarian |
| Omnivorous dietIndividuals reporting regular consumption of meat (including red meat, poultry, or fish), dairy products, and/or eggs. | Behavioural | Omnivorous |
Primary outcome
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.
Total Cholesterol
Time frame: 12/2025 - 12/2027
Serum total cholesterol concentration (mg/dl)
LDL-Cholesterol
Time frame: 12/2025 - 12/2027
Serum LDL cholesterol concentration calculated by Friedewald equation (mg/dl)
HDL-Cholesterol
Time frame: 12/2025 - 12/2027
Serum HDL-cholesterol concentration (mg/dl)
Triglycerides
Time frame: 12/2025 - 12/2027
Serum triglycerides concentration (mg/dl)
Fasting glucose
Time frame: 12/2025 - 12/2027
Serum fasting glucose concentration (mg/dl)
HbA1c
Time frame: 12/2025 - 12/2027
Glycated hemoglobin percentage (%)
Fasting Insulin
Time frame: 12/2025 - 12/2027
Serum fasting insulin concentration (µIU/mL)
HOMA-IR
Time frame: 12/2025 - 12/2027
Homeostatic Model Assessment of Insulin Resistance, calculated using fasting glucose and fasting insulin concentrations.
High-sensitivity C-reactive Protein
Time frame: 12/2025 - 12/2027
Serum High-sensitivity C-reactive Protein concentration (mg/L)
Uric Acid
Time frame: 12/2025 - 12/2027
Serum uric acid concentration (mg/dL)
Vitamin B12
Time frame: 12/2025 - 12/2027
Serum vitamin B12 concentration (pg/mL)
Homocysteine
Time frame: 12/2025 - 12/2027
Plasma homocysteine concentration (µmol/L)
25-hydroxy Vitamin D
Time frame: 12/2025 - 12/2027
Serum 25(OH)D concentration (ng/mL)
Serum Iron
Time frame: 12/2025 - 12/2027
Serum iron concentration (µg/dL)
Ferritin
Time frame: 12/2025 - 12/2027
Serum ferritin concentration(ng/mL)
Transferrin
Time frame: 12/2025 - 12/2027
Serum transferrin concentration(mg/dL)
Transferrin Saturation
Time frame: 12/2025 - 12/2027
Percentage of transferrin saturation calculated from serum iron and total iron-binding capacity (%)
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.
Blood Pressure
Time frame: 12/2025 - 12/2027
Systolic and diastolic blood pressure measured in mmHg using a validated automated device.
Body Weight
Time frame: 12/2025 - 12/2027
Body weight measured in kilograms (kg) using a calibrated scale.
Body Mass Index (BMI)
Time frame: 12/2025 - 12/2027
BMI calculated as weight divided by height squared (kg/m²).
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.
Hip Circumference
Time frame: 12/2025 - 12/2027
Hip circumference measured in centimeters (cm) at the level of the greater trochanters.
Waist-to-Hip Ratio
Time frame: 12/2025 - 12/2027
Waist-to-hip ratio calculated as waist circumference divided by hip circumference (unitless).
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 %).
15 secondary outcomes
Supplement use
Time frame: 12/2025 - 12/2027
Satisfaction with the current diet
Time frame: 12/2025 - 12/2027
Physical activity levels and global quality of life
Time frame: 12/2025 - 12/2027
Reasons for adopting dietary patterns
Time frame: 12/2025 - 12/2027
Alcohol and tobacco use
Time frame: 12/2025 - 12/2027
Serum Urea
Time frame: 12/2025 - 12/2027
Serum Creatinine
Time frame: 12/2025 - 12/2027
Alanine Aminotransferase (ALT/GPT)
Time frame: 12/2025 - 12/2027
Aspartate Aminotransferase (AST/GOT)
Time frame: 12/2025 - 12/2027
Alkaline Phosphatase (ALP)
Time frame: 12/2025 - 12/2027
Bilirubin
Time frame: 12/2025 - 12/2027
Bilirubin
Time frame: 12/2025 - 12/2027
Total Protein
Time frame: 12/2025 - 12/2027
Thyroid-Stimulating Hormone (TSH)
Time frame: 12/2025 - 12/2027
Grip Strength
Time frame: 12/2025 - 12/2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Official study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data available under request for research purposes, and after evaluation by the investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular (CV) Risk and Nutrition, run by Universidad del Centro Educativo Latinoamericano at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariel Kraselnik, MD (+54 9 11 5869 8996, akraselnik@ucel.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Composition (time frame: 12/2025 - 12/2027). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.