Cardiovascular (CV) RiskERRMNCT07205237
Effect of Eliminating Red Meat Consumption on the Cardiovascular System
A study testing Diet without Red and Processed Meat in people with Cardiovascular (CV) Risk, run by Maria Clara Rocha at 1 site in Portugal.
Trial summary
The objective of this clinical trial is to evaluate, in clinically healthy young omnivores, whether excluding red and processed meat from their diets for four weeks results in: measurable changes in arterial structure and function; measurable changes in key metabolic parameters. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular (CV) Risk
- What is being tested?
- Diet without Red and Processed Meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Feb 2023to 3 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young people;
- Young people who have followed an omnivorous diet for at least one year.
Who cannot join
- Previous alcohol or coffee abuse;
- Use of vitamin B12 supplements;
- Unstable clinical status;
- Individuals with anemia, hypertension, high cholesterol, diabetes, or a history of cardiovascular disease;
- Chronic use of medications, except oral contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Eliminating Red Meat Consumption on the Cardiovascular System - A Longitudinal Study
The objective of this clinical trial is to evaluate, in clinically healthy young omnivores, whether excluding red and processed meat from their diets for four weeks results in:
- measurable changes in arterial structure and function;
- measurable changes in key metabolic parameters.
Read more
The sample consisted of clinically healthy young people who had been following an omnivorous diet for at least one year. Those with a history that could influence the results were excluded. Exclusion criteria included alcohol or coffee abuse, vitamin B12 supplement intake, anemia, hypertension, cholesterol, diabetes, a history of cardiovascular disease, or an unstable clinical situation. Participants taking chronic medication, except those using oral contraceptives, were also excluded.
A single-group longitudinal study design is adopted, comprising a 4-week intervention period. Each participant undergoes two assessments: at baseline (T0) and 4 weeks after eliminating red/processed meat from the diet (T1). After being informed about the study and signing the informed consent form, participants are asked to complete a questionnaire containing information on sociodemographic (sex, age, weight, and height), behavioral (diet, smoking, alcohol consumption, coffee, vitamin B12 supplements, energy drinks, and sports activity), and clinical parameters (use of oral contraceptives, medications, anemia, hypertension, cholesterol, diabetes, and personal history of CVD). Participants are also instructed to replace red and processed meat in their daily diet with fish, eggs, or white meat, and to maintain the food proportions of their meals unchanged.
Read the detailed description
Biochemical and Haematological parameters:
To determine blood parameters, 10 ml of peripheral blood was collected by venipuncture for serum and plasma in K3EDTA tubes. The biochemical profile was determined spectrophotometrically on a Prestige 24i chemistry analyzer (Tokyo Boeky, Tokyo, Japan) with reagents from Cormay® (Warsaw, Poland). Complete blood counts are performed on a Cell-Dyn Sapphire™ hematology analyzer (Abbott Laboratories, Santa Clara, CA, USA).
Approximately 7 mL of venous blood is collected per sample in a dry gel tube and centrifuged under vacuum at 1800 g, 4°C for 10 minutes. The serum is then separated into aliquots and stored at -20°C until the desired parameters are achieved. The analytical parameters total cholesterol, HDL-C, LDL-C, triglycerides, and glucose are obtained using the corresponding kit from Cormay, Poland. Concentrations are assessed spectrophotometrically according to the protocol and using the Prestige 24i equipment (TOKYO BOEKI MEDICAL SYSTEM LTD, Tokyo, Japan). The K3EDTA tube is used to perform complete blood counts on the Cell-Dyn Sapphire™ equipment (Abbott Laboratories, Santa Clara, CA, USA). All tests were validated and subjected to quality control.
Vascular parameters:
Participants are placed in the supine position and have a 5-minute rest period before data collection. Subsequently, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are measured. The cuff is placed on the right arm, aligned with the brachial artery, and adjusted to the arm circumference.
The common carotid artery (CCA) is assessed using a GE® Vivid T8 ultrasound device with a 6-12 MHz linear probe. The participant is placed in the supine position with the neck in slight hyperextension. A longitudinal section of the CCA is taken, and the image is saved for measurement of systolic (SD) and diastolic diameters (DD) and intima-media thickness (IMT). Subsequently, peak systolic (PSV) and endodiastolic (ED) velocities of the CCA are recorded using pulsed Doppler. Assessments are performed bilaterally. All measurements are performed with the aid of an electrocardiogram electrode.
- Conditions
- Cardiovascular (CV) Risk
- Being tested
- Diet without Red and Processed Meat
- Keywords
- Red meat, Processed meat, Omnivorous, Carotid disease, Lipid changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet without Red and Processed MeatDietary supplement
Participants replaced red and processed meat in their daily diet with fish, eggs, or white meat, while keeping the food proportions of their meals unchanged.
| Study group | Role | What they receive |
|---|---|---|
| Single Group - Diet without Red and Processed Meat | Experimental | All participants follow a four-week diet excluding red and processed meat. Vascular, biochemical, and hematological parameters are assessed at baseline and post-intervention. Receives: Dietary Supplement: Diet without Red and Processed Meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hematological Parameters - Haemoglobin
Changes in mean hemoglobin, measured in g/dL, from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Measured: 4 weeks
Changes in Hematological Parameters - Reticulocytes
Changes in mean reticulocytes, measured in percentage, from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Measured: 4 weeks
Changes in Biochemical Parameters
Changes in mean biochemical parameters, namely Total Cholesterol, Triglycerides, HDL-C (High Density Lipoprotein Cholesterol), LDL-C (Low Density Lipoprotein Cholesterol), and Glucose, measured in mg/dL, from baseline to 4 weeks after the exclusion of red and processed meat from the study participants' diets.
Measured: 4 weeks
Changes in Vascular Parameters - Common Carotid Artery diameters
Changes in mean systolic and mean diastolic diameters of the common carotid artery, measured in millimeters, from baseline to 4 weeks after the exclusion of red and processed meat from the diet of study participants.
Measured: 4 weeks
Changes in Vascular Parameters - Common Carotid Artery Velocity
Changes in mean Peak Systolic velocity and Endodiastolic velocity of the common carotid artery, measured in cm/s, from baseline to 4 weeks after the exclusion of red and processed meat from the diet of study participants.
Measured: 4 weeks
Changes in Vascular Parameters - Intima-Media Tickness
Changes in mean Intima-Media Tickness, measure in millimeters, from baseline to 4 weeks after the exclusion of red and processed meat from the diet of study participants.
Measured: 4 weeks
Changes in Vascular Parameters - Beta Stiffness index
Changes in mean common carotid artery beta stiffness index from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Measured: 4 weeks
Changes in Vascular Parameters - Compliance
Changes in mean compliance, measure in mm^2. mm Hg^( -1), from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Measured: 4 weeks
Changes in Vascular Parameters - Heart Rate
Changes in mean heart rate, measure in bpm, from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start2 Feb 2023
- Primary completion3 May 2023
- Study completion3 May 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group longitudinal study design was adopted, comprising a 4-week intervention period. Each participant was submitted to 2 evaluation times: at baseline (T0), 4 weeks after eliminating red/processed meat from the diet (T1). The sample was obtained into two different laboratories, in each of which different parameters were assessed: Haematological and Vascular parameters. After clarification of the study and signed informed consent, participants were asked to complete a questionnaire containing information on sociodemographic parameters (gender, age, weight and height), behavioural parameters (diet, smoking, alcohol consumption, coffee, vitamin B12 supplements and energy drinks consumption and sports practice) and clinical parameters (use of oral contraception, medication, anaemia, hypertension, cholesterol, diabetes and personal history of CVD). Participants were also instructed to replace red and processed meat from their daily diet, replacing it with fish, eggs or white meat.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Clara Rocha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Clara Rocha, Escola Superior de Tecnologia da Saúde de Coimbra
- Investigators
- Helder Santos, Principal investigator, Health School-Polytechnic Institute of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205237
- Sponsor's protocol ID
- ERRM2025
- Acronym
- ERRM
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eliminating Red Meat Consumption on the Cardiovascular System - A Longitudinal Study
- ClinicalTrials.gov ID
- NCT07205237
- Acronym / sponsor ID
- ERRM / ERRM2025
- Conditions
- Cardiovascular (CV) Risk
- Keywords
- Red meat, Processed meat, Omnivorous, Carotid disease, Lipid changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maria Clara RochaUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2025 (actual)
- First posted
- 3 Oct 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 objective of this clinical trial is to evaluate, in clinically healthy young omnivores, whether excluding red and processed meat from their diets for four weeks results in:
- measurable changes in arterial structure and function;
- measurable changes in key metabolic parameters.
The sample consisted of clinically healthy young people who had been following an omnivorous diet for at least one year. Those with a history that could influence the results were excluded. Exclusion criteria included alcohol or coffee abuse, vitamin B12 supplement intake, anemia, hypertension, cholesterol, diabetes, a history of cardiovascular disease, or an unstable clinical situation. Participants taking chronic medication, except those using oral contraceptives, were also excluded.
A single-group longitudinal study design is adopted, comprising a 4-week intervention period. Each participant undergoes two assessments: at baseline (T0) and 4 weeks after eliminating red/processed meat from the diet (T1). After being informed about the study and signing the informed consent form, participants are asked to complete a questionnaire containing information on sociodemographic (sex, age, weight, and height), behavioral (diet, smoking, alcohol consumption, coffee, vitamin B12 supplements, energy drinks, and sports activity), and clinical parameters (use of oral contraceptives, medications, anemia, hypertension, cholesterol, diabetes, and personal history of CVD). Participants are also instructed to replace red and processed meat in their daily diet with fish, eggs, or white meat, and to maintain the food proportions of their meals unchanged.
Detailed description
Biochemical and Haematological parameters:
To determine blood parameters, 10 ml of peripheral blood was collected by venipuncture for serum and plasma in K3EDTA tubes. The biochemical profile was determined spectrophotometrically on a Prestige 24i chemistry analyzer (Tokyo Boeky, Tokyo, Japan) with reagents from Cormay® (Warsaw, Poland). Complete blood counts are performed on a Cell-Dyn Sapphire™ hematology analyzer (Abbott Laboratories, Santa Clara, CA, USA).
Approximately 7 mL of venous blood is collected per sample in a dry gel tube and centrifuged under vacuum at 1800 g, 4°C for 10 minutes. The serum is then separated into aliquots and stored at -20°C until the desired parameters are achieved. The analytical parameters total cholesterol, HDL-C, LDL-C, triglycerides, and glucose are obtained using the corresponding kit from Cormay, Poland. Concentrations are assessed spectrophotometrically according to the protocol and using the Prestige 24i equipment (TOKYO BOEKI MEDICAL SYSTEM LTD, Tokyo, Japan). The K3EDTA tube is used to perform complete blood counts on the Cell-Dyn Sapphire™ equipment (Abbott Laboratories, Santa Clara, CA, USA). All tests were validated and subjected to quality control.
Vascular parameters:
Participants are placed in the supine position and have a 5-minute rest period before data collection. Subsequently, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are measured. The cuff is placed on the right arm, aligned with the brachial artery, and adjusted to the arm circumference.
The common carotid artery (CCA) is assessed using a GE® Vivid T8 ultrasound device with a 6-12 MHz linear probe. The participant is placed in the supine position with the neck in slight hyperextension. A longitudinal section of the CCA is taken, and the image is saved for measurement of systolic (SD) and diastolic diameters (DD) and intima-media thickness (IMT). Subsequently, peak systolic (PSV) and endodiastolic (ED) velocities of the CCA are recorded using pulsed Doppler. Assessments are performed bilaterally. All measurements are performed with the aid of an electrocardiogram electrode.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group longitudinal study design was adopted, comprising a 4-week intervention period. Each participant was submitted to 2 evaluation times: at baseline (T0), 4 weeks after eliminating red/processed meat from the diet (T1). The sample was obtained into two different laboratories, in each of which different parameters were assessed: Haematological and Vascular parameters. After clarification of the study and signed informed consent, participants were asked to complete a questionnaire containing information on sociodemographic parameters (gender, age, weight and height), behavioural parameters (diet, smoking, alcohol consumption, coffee, vitamin B12 supplements and energy drinks consumption and sports practice) and clinical parameters (use of oral contraception, medication, anaemia, hypertension, cholesterol, diabetes and personal history of CVD). Participants were also instructed to replace red and processed meat from their daily diet, replacing it with fish, eggs or white meat.
| Arm | Type | Receives |
|---|---|---|
| Single Group - Diet without Red and Processed Meat | Experimental | Dietary Supplement: Diet without Red and Processed MeatAll participants follow a four-week diet excluding red and processed meat. Vascular, biochemical, and hematological parameters are assessed at baseline and post-intervention. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy young people;
- Young people who have followed an omnivorous diet for at least one year.
Key exclusion criteria (5 listed)
- Previous alcohol or coffee abuse;
- Use of vitamin B12 supplements;
- Unstable clinical status;
- Individuals with anemia, hypertension, high cholesterol, diabetes, or a history of cardiovascular disease;
- Chronic use of medications, except oral contraceptives.
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 |
|---|---|---|
| Diet without Red and Processed MeatParticipants replaced red and processed meat in their daily diet with fish, eggs, or white meat, while keeping the food proportions of their meals unchanged. | Dietary supplement | Single Group - Diet without Red and Processed Meat |
Primary outcome
Changes in Hematological Parameters - Haemoglobin
Time frame: 4 weeks
Changes in mean hemoglobin, measured in g/dL, from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Changes in Hematological Parameters - Reticulocytes
Time frame: 4 weeks
Changes in mean reticulocytes, measured in percentage, from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Changes in Biochemical Parameters
Time frame: 4 weeks
Changes in mean biochemical parameters, namely Total Cholesterol, Triglycerides, HDL-C (High Density Lipoprotein Cholesterol), LDL-C (Low Density Lipoprotein Cholesterol), and Glucose, measured in mg/dL, from baseline to 4 weeks after the exclusion of red and processed meat from the study participants' diets.
Changes in Vascular Parameters - Common Carotid Artery diameters
Time frame: 4 weeks
Changes in mean systolic and mean diastolic diameters of the common carotid artery, measured in millimeters, from baseline to 4 weeks after the exclusion of red and processed meat from the diet of study participants.
Changes in Vascular Parameters - Common Carotid Artery Velocity
Time frame: 4 weeks
Changes in mean Peak Systolic velocity and Endodiastolic velocity of the common carotid artery, measured in cm/s, from baseline to 4 weeks after the exclusion of red and processed meat from the diet of study participants.
Changes in Vascular Parameters - Intima-Media Tickness
Time frame: 4 weeks
Changes in mean Intima-Media Tickness, measure in millimeters, from baseline to 4 weeks after the exclusion of red and processed meat from the diet of study participants.
Changes in Vascular Parameters - Beta Stiffness index
Time frame: 4 weeks
Changes in mean common carotid artery beta stiffness index from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Changes in Vascular Parameters - Compliance
Time frame: 4 weeks
Changes in mean compliance, measure in mm^2. mm Hg^( -1), from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Changes in Vascular Parameters - Heart Rate
Time frame: 4 weeks
Changes in mean heart rate, measure in bpm, from baseline to 4 weeks after excluding red and processed meat from the study participants' diets.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
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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. This study is not recruiting at the moment.
Helder Santos principal investigator
Health School-Polytechnic Institute of Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet without Red and Processed Meat in people with Cardiovascular (CV) Risk, run by Maria Clara Rocha at 1 site in Portugal.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hematological Parameters - Haemoglobin (time frame: 4 weeks). The study lists 9 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 Oct 2025.