Healthy Adult ParticipantsMED-SWAPNCT07847996
Replacing Meat With Legumes in a Mediterranean Diet
A study testing Mediterranean Diet With Grass-Fed Organic Meat and Mediterranean Diet With Legumes in people with Healthy Adult Participants, run by Universidad Francisco de Vitoria.
Trial summary
This study will investigate whether replacing grass-fed organic meat with legumes within a Mediterranean diet affects cardiometabolic health in healthy adults. Participants will be randomly assigned to follow a Mediterranean diet that includes either grass-fed organic meat or legumes as the main protein source for 8… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Mediterranean Diet With Grass-Fed Organic Meat and Mediterranean Diet With Legumes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2026to 14 Dec 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Body mass index (BMI) 18.5-29.9 kg/m².
- No previous diagnosis of cardiovascular disease, diabetes mellitus, kidney disease, or chronic inflammatory disease.
- Habitual consumption of meat and willingness to follow the assigned dietary intervention.
- No vegetarian or vegan diet during the previous 6 months.
- Ability to provide written informed consent.
Who cannot join
- Use of lipid-lowering, antihypertensive, or antidiabetic medication.
- Pregnancy or breastfeeding.
- Allergy or intolerance to legumes or meat.
- Significant gastrointestinal disorders.
- No tobacco use.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Replacing Grass-Fed Organic Meat With Legumes Within a Mediterranean Diet on Cardiometabolic Biomarkers in Healthy Adults: A Randomized Controlled Trial
This study will investigate whether replacing grass-fed organic meat with legumes within a Mediterranean diet affects cardiometabolic health in healthy adults. Participants will be randomly assigned to follow a Mediterranean diet that includes either grass-fed organic meat or legumes as the main protein source for 8 weeks. The study will compare changes in blood cholesterol, blood glucose, inflammation, blood pressure, and other health measures between the two groups. The main outcome will be the change in LDL cholesterol, a type of cholesterol associated with cardiovascular health. The study will include healthy adults aged 25 to 65 years living in the Community of Madrid, Spain.
Read the detailed description
The Mediterranean diet is a dietary pattern associated with cardiovascular health and is characterized by a high consumption of plant foods, including vegetables, fruits, whole grains, legumes, nuts, and olive oil. Within this dietary pattern, different combinations of animal- and plant-based protein sources can be used while maintaining the overall characteristics of the diet.
Legumes provide protein, dietary fiber, resistant starch, phytosterols, and phenolic compounds, which may influence lipid and glucose metabolism. Meat provides high-quality protein and highly bioavailable micronutrients, while its nutritional composition may vary according to the production system. In particular, meat from pasture-fed animals may differ in fatty acid composition and other nutritional characteristics from meat produced using conventional intensive systems.
Previous studies have investigated the effects of replacing meat with legumes on cardiometabolic health. However, much of the available evidence has evaluated conventional meat sources or has compared broader dietary patterns rather than specifically examining the replacement of grass-fed organic meat with legumes while maintaining a Mediterranean dietary pattern. Therefore, the cardiometabolic effects of this specific dietary substitution remain insufficiently characterized.
The MED-SWAP study is a randomized, controlled, parallel-group clinical trial designed to investigate the effects of replacing grass-fed organic meat with legumes within a Mediterranean diet. Participants will be randomly assigned to one of two dietary interventions for 8 weeks. Both groups will follow a structured Mediterranean dietary pattern, with the main systematic difference being the principal protein source.
The control group will follow a Mediterranean diet including grass-fed organic meat, consisting of at least four servings per week of a mixture of red and white meat, while limiting legumes as a main dish to a maximum of one serving per week. The intervention group will follow a Mediterranean diet including legumes, with at least four servings per week of legumes such as lentils, chickpeas, beans, or traditional soy, while limiting grass-fed organic meat to a maximum of one serving per week.
The replacement of meat with legumes will be designed to be isocaloric, with the aim of maintaining comparable total energy intake and the overall macronutrient distribution between groups. The remaining components of the Mediterranean dietary pattern will be structured similarly in both groups. Participants will receive structured menus, standard serving sizes, and food equivalences to facilitate adherence and standardization.
Dietary adherence will be monitored throughout the intervention using periodic 3-day dietary records, including one weekend day, 24-hour dietary recalls, and regular contacts with a dietitian-nutritionist. Adherence to the prescribed weekly servings of the main protein source will also be assessed during follow-up visits. Participants who show inadequate adherence will receive individualized dietary reinforcement and will remain in the study whenever possible.
The study will evaluate whether this specific modification of the protein sources within a Mediterranean dietary pattern is associated with differences in cardiometabolic biomarkers after the 8-week intervention. The primary outcome is the change in LDL cholesterol. Secondary assessments include other lipid parameters, glucose metabolism, inflammatory markers, blood pressure, anthropometric measures, and the neutrophil-to-lymphocyte ratio.
The study will provide clinical evidence on the effects of modifying the relative contribution of animal and plant protein sources within a Mediterranean dietary pattern, with particular emphasis on the substitution of grass-fed organic meat with legumes. The findings may contribute to a better understanding of how specific food substitutions within an established healthy dietary pattern relate to cardiometabolic health.
- Conditions
- Healthy Adult Participants
- Being tested
- Mediterranean Diet With Grass-Fed Organic Meat, Mediterranean Diet With Legumes
- Keywords
- legumes, meat, mediterranean diet, plant-based diet, cardiometabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet With Grass-Fed Organic MeatBehavioural
Participants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of grass-fed organic meat, consisting of a mixture of red and white meat. Consumption of legumes as a main dish will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist.
Mediterranean Diet With LegumesBehavioural
Participants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of legumes, such as lentils, chickpeas, beans, or traditional soy. Consumption of meat will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet With Grass-Fed Organic Meat | Active comparator | Participants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of grass-fed organic meat, consisting of a mixture of red and white meat. Consumption of legumes as a main dish will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist. Receives: Behavioral: Mediterranean Diet With Grass-Fed Organic Meat |
| Mediterranean Diet With Legumes | Experimental | Participants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of legumes, such as lentils, chickpeas, beans, or traditional soy. Consumption of meat will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist. Receives: Behavioral: Mediterranean Diet With Legumes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL Cholesterol (LDL-C)
Change in LDL cholesterol from baseline to week 8, measured in mg/dL. The effect of the intervention will be assessed by comparing the change in LDL cholesterol between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Secondary outcomes (24)
Change in HDL Cholesterol (HDL-C)
Change in HDL cholesterol from baseline to week 8, measured in mg/dL. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Triglycerides
Change in blood triglyceride concentration from baseline to week 8, measured in mg/dL. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Fasting Blood Glucose
Change in fasting blood glucose from baseline to week 8, measured in mg/dL. Blood samples will be collected after an overnight fast. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Fasting Insulin
Change in fasting insulin concentration from baseline to week 8, measured in appropriate laboratory units. Blood samples will be collected after an overnight fast. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in HOMA-IR
Change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to week 8. HOMA-IR will be calculated from fasting glucose and fasting insulin measurements. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in High-Sensitivity C-Reactive Protein
Change in high-sensitivity C-reactive protein (hs-CRP) concentration from baseline to week 8, measured in mg/L. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Neutrophil-to-Lymphocyte Ratio
Change in the neutrophil-to-lymphocyte ratio (NLR) from baseline to week 8. NLR will be calculated from neutrophil and lymphocyte counts obtained from the complete blood count. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Body Mass Index
Change in body mass index (BMI) from baseline to week 8, calculated as body weight in kilograms divided by height in meters squared (kg/m²). The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Waist Circumference
Change in waist circumference from baseline to week 8, measured in centimeters. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline to week 8, measured in mmHg. Blood pressure will be assessed using the mean of three measurements. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline to week 8, measured in mmHg. Blood pressure will be assessed using the mean of three measurements. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Total Testosterone
Change in total testosterone concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Serum Cortisol
Change in serum cortisol concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Serum Iron
Change in serum iron concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Serum Ferritin
Change in serum ferritin concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Serum Transferrin
Change in serum transferrin concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Insulin-Like Growth Factor 1
Change in insulin-like growth factor 1 (IGF-1) concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Hemoglobin A1c
Change in hemoglobin A1c (HbA1c) from baseline to week 8, measured as a percentage. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Apolipoprotein B
Change in apolipoprotein B (ApoB) concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Apolipoprotein A-I
Change in apolipoprotein A-I (ApoA-I) concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Lipoprotein(a)
Baseline concentration of lipoprotein(a) [Lp(a)], measured in appropriate laboratory units before the dietary intervention.
Measured: Baseline
Change in Fat Mass
Change in total fat mass from baseline to week 8, measured in kilograms. Body composition will be assessed at baseline and week 8 using the study's standardized body composition assessment method. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Fat-Free Mass
Change in fat-free mass from baseline to week 8, measured in kilograms. Body composition will be assessed at baseline and week 8 using the study's standardized body composition assessment method. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Change in Body Fat Percentage
Change in body fat percentage from baseline to week 8, expressed as a percentage. Body composition will be assessed at baseline and week 8 using the study's standardized body composition assessment method. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start13 Oct 2026 (estimated)
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel López Moreno, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847996
- Sponsor's protocol ID
- PI 43/26
- Acronym
- MED-SWAP
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data-sharing plan has been established for this study. Results will be reported and shared in aggregate form through scientific publications and other dissemination activities.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Replacing Grass-Fed Organic Meat With Legumes Within a Mediterranean Diet on Cardiometabolic Biomarkers in Healthy Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07847996
- Acronym / sponsor ID
- MED-SWAP / PI 43/26
- Conditions
- Healthy Adult Participants
- Keywords
- legumes, meat, mediterranean diet, plant-based diet, cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 29 Sep 2026 (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.
This study will investigate whether replacing grass-fed organic meat with legumes within a Mediterranean diet affects cardiometabolic health in healthy adults. Participants will be randomly assigned to follow a Mediterranean diet that includes either grass-fed organic meat or legumes as the main protein source for 8 weeks. The study will compare changes in blood cholesterol, blood glucose, inflammation, blood pressure, and other health measures between the two groups. The main outcome will be the change in LDL cholesterol, a type of cholesterol associated with cardiovascular health. The study will include healthy adults aged 25 to 65 years living in the Community of Madrid, Spain.
Detailed description
The Mediterranean diet is a dietary pattern associated with cardiovascular health and is characterized by a high consumption of plant foods, including vegetables, fruits, whole grains, legumes, nuts, and olive oil. Within this dietary pattern, different combinations of animal- and plant-based protein sources can be used while maintaining the overall characteristics of the diet.
Legumes provide protein, dietary fiber, resistant starch, phytosterols, and phenolic compounds, which may influence lipid and glucose metabolism. Meat provides high-quality protein and highly bioavailable micronutrients, while its nutritional composition may vary according to the production system. In particular, meat from pasture-fed animals may differ in fatty acid composition and other nutritional characteristics from meat produced using conventional intensive systems.
Previous studies have investigated the effects of replacing meat with legumes on cardiometabolic health. However, much of the available evidence has evaluated conventional meat sources or has compared broader dietary patterns rather than specifically examining the replacement of grass-fed organic meat with legumes while maintaining a Mediterranean dietary pattern. Therefore, the cardiometabolic effects of this specific dietary substitution remain insufficiently characterized.
The MED-SWAP study is a randomized, controlled, parallel-group clinical trial designed to investigate the effects of replacing grass-fed organic meat with legumes within a Mediterranean diet. Participants will be randomly assigned to one of two dietary interventions for 8 weeks. Both groups will follow a structured Mediterranean dietary pattern, with the main systematic difference being the principal protein source.
The control group will follow a Mediterranean diet including grass-fed organic meat, consisting of at least four servings per week of a mixture of red and white meat, while limiting legumes as a main dish to a maximum of one serving per week. The intervention group will follow a Mediterranean diet including legumes, with at least four servings per week of legumes such as lentils, chickpeas, beans, or traditional soy, while limiting grass-fed organic meat to a maximum of one serving per week.
The replacement of meat with legumes will be designed to be isocaloric, with the aim of maintaining comparable total energy intake and the overall macronutrient distribution between groups. The remaining components of the Mediterranean dietary pattern will be structured similarly in both groups. Participants will receive structured menus, standard serving sizes, and food equivalences to facilitate adherence and standardization.
Dietary adherence will be monitored throughout the intervention using periodic 3-day dietary records, including one weekend day, 24-hour dietary recalls, and regular contacts with a dietitian-nutritionist. Adherence to the prescribed weekly servings of the main protein source will also be assessed during follow-up visits. Participants who show inadequate adherence will receive individualized dietary reinforcement and will remain in the study whenever possible.
The study will evaluate whether this specific modification of the protein sources within a Mediterranean dietary pattern is associated with differences in cardiometabolic biomarkers after the 8-week intervention. The primary outcome is the change in LDL cholesterol. Secondary assessments include other lipid parameters, glucose metabolism, inflammatory markers, blood pressure, anthropometric measures, and the neutrophil-to-lymphocyte ratio.
The study will provide clinical evidence on the effects of modifying the relative contribution of animal and plant protein sources within a Mediterranean dietary pattern, with particular emphasis on the substitution of grass-fed organic meat with legumes. The findings may contribute to a better understanding of how specific food substitutions within an established healthy dietary pattern relate to cardiometabolic health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet With Grass-Fed Organic Meat | Active comparator | Behavioral: Mediterranean Diet With Grass-Fed Organic MeatParticipants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of grass-fed organic meat, consisting of a mixture of red and white meat. Consumption of legumes as a main dish will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist. |
| Mediterranean Diet With Legumes | Experimental | Behavioral: Mediterranean Diet With LegumesParticipants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of legumes, such as lentils, chickpeas, beans, or traditional soy. Consumption of meat will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 years.
- Body mass index (BMI) 18.5-29.9 kg/m².
- No previous diagnosis of cardiovascular disease, diabetes mellitus, kidney disease, or chronic inflammatory disease.
- Habitual consumption of meat and willingness to follow the assigned dietary intervention.
- No vegetarian or vegan diet during the previous 6 months.
Key exclusion criteria (5 listed)
- Use of lipid-lowering, antihypertensive, or antidiabetic medication.
- Pregnancy or breastfeeding.
- Allergy or intolerance to legumes or meat.
- Significant gastrointestinal disorders.
- No tobacco use.
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 |
|---|---|---|
| Mediterranean Diet With Grass-Fed Organic MeatParticipants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of grass-fed organic meat, consisting of a mixture of red and white meat. Consumption of legumes as a main dish will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist. | Behavioural | Mediterranean Diet With Grass-Fed Organic Meat |
| Mediterranean Diet With LegumesParticipants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of legumes, such as lentils, chickpeas, beans, or traditional soy. Consumption of meat will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist. | Behavioural | Mediterranean Diet With Legumes |
Primary outcome
Change in LDL Cholesterol (LDL-C)
Time frame: Baseline to Week 8
Change in LDL cholesterol from baseline to week 8, measured in mg/dL. The effect of the intervention will be assessed by comparing the change in LDL cholesterol between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.
24 secondary outcomes
Change in HDL Cholesterol (HDL-C)
Time frame: Baseline to Week 8
Change in Triglycerides
Time frame: Baseline to Week 8
Change in Fasting Blood Glucose
Time frame: Baseline to Week 8
Change in Fasting Insulin
Time frame: Baseline to Week 8
Change in HOMA-IR
Time frame: Baseline to Week 8
Change in High-Sensitivity C-Reactive Protein
Time frame: Baseline to Week 8
Change in Neutrophil-to-Lymphocyte Ratio
Time frame: Baseline to Week 8
Change in Body Mass Index
Time frame: Baseline to Week 8
Change in Waist Circumference
Time frame: Baseline to Week 8
Change in Systolic Blood Pressure
Time frame: Baseline to Week 8
Change in Diastolic Blood Pressure
Time frame: Baseline to Week 8
Change in Total Testosterone
Time frame: Baseline to Week 8
Change in Serum Cortisol
Time frame: Baseline to Week 8
Change in Serum Iron
Time frame: Baseline to Week 8
Change in Serum Ferritin
Time frame: Baseline to Week 8
Change in Serum Transferrin
Time frame: Baseline to Week 8
Change in Insulin-Like Growth Factor 1
Time frame: Baseline to Week 8
Change in Hemoglobin A1c
Time frame: Baseline to Week 8
Change in Apolipoprotein B
Time frame: Baseline to Week 8
Change in Apolipoprotein A-I
Time frame: Baseline to Week 8
Lipoprotein(a)
Time frame: Baseline
Change in Fat Mass
Time frame: Baseline to Week 8
Change in Fat-Free Mass
Time frame: Baseline to Week 8
Change in Body Fat Percentage
Time frame: Baseline to Week 8
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 29 Sep 2026.
- Individual participant dataSharing planned: No. No individual participant data-sharing plan has been established for this study. Results will be reported and shared in aggregate form through scientific publications and other dissemination activities.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet With Grass-Fed Organic Meat and Mediterranean Diet With Legumes in people with Healthy Adult Participants, run by Universidad Francisco de Vitoria.
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 6 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Miguel López Moreno, PhD (+34647892334, miguel.lopez@ufv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL Cholesterol (LDL-C) (time frame: Baseline to Week 8). 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 29 Sep 2026.