Replacing Meat With Legumes in a Mediterranean Diet
ConditionHealthy Adult Participants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad Francisco de Vitoria
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Use of lipid-lowering, antihypertensive, or antidiabetic medication.
Pregnancy or breastfeeding.
Allergy or intolerance to legumes or meat.
Significant gastrointestinal disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Mediterranean Diet With Grass-Fed Organic Meat
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Mediterranean Diet With Grass-Fed Organic MeatActive comparator 1 intervention
Group B: Mediterranean Diet With LegumesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Week 8Secondary outcomes
1
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.
Time frame
Baseline to Week 82
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.
Time frame
Baseline to Week 83
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.
Time frame
Baseline to Week 84
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.
Time frame
Baseline to Week 8Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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