Effect of Eliminating Red Meat Consumption on the Cardiovascular System

NCT07205237 | Completed DMC

• 1 other identifier: ERRM2025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular (CV) Risk

Keywords

Red meat; Processed meat; Omnivorous; Carotid disease; Lipid changes

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  4 weeks

Study Arms (1)

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.

Dietary Supplement: Diet without Red and Processed Meat

Interventions

Diet without Red and Processed Meat DIETARY_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.

Single Group - Diet without Red and Processed Meat

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy young people;
• Young people who have followed an omnivorous diet for at least one year.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Clara Rocha: lead

Study Sites (1)

Health School-Polytechnic Institute of Coimbra

Coimbra, Portugal

Location

MeSH Terms

Interventions

Diet; Dyrk Kinases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Protein-Tyrosine Kinases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Helder Santos

  Health School-Polytechnic Institute of Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: October 3, 2025
• Study Start: February 2, 2023
• Primary Completion: May 3, 2023
• Study Completion: May 3, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared via the author's email.

Locations

PT (1)