Replacing Meat With Legumes in a Mediterranean Diet

NCT07847996 | Not Yet Recruiting

• 1 other identifier: PI 43/26
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Healthy Adult Participants

Keywords

legumes; meat; mediterranean diet; plant-based diet; cardiometabolic health

Outcome Measures

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.

  Baseline to Week 8

Secondary Outcomes (24)

• Change in HDL Cholesterol (HDL-C)

  Baseline to Week 8

• Change in Triglycerides

  Baseline to Week 8

• Change in Fasting Blood Glucose

  Baseline to Week 8

• Change in Fasting Insulin

  Baseline to Week 8

• Change in HOMA-IR

  Baseline to Week 8

Study Arms (2)

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.

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.

Behavioral: Mediterranean Diet With Legumes

Interventions

Mediterranean Diet With Grass-Fed Organic Meat BEHAVIORAL

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 Grass-Fed Organic Meat

Mediterranean Diet With Legumes BEHAVIORAL

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.

Mediterranean Diet With Legumes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Use of lipid-lowering, antihypertensive, or antidiabetic medication.
• Pregnancy or breastfeeding.
• Allergy or intolerance to legumes or meat.
• Significant gastrointestinal disorders.
• No tobacco use.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

MeSH Terms

Interventions

Diet, Mediterranean

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Miguel López Moreno, PhD

CONTACT

+34647892334; miguel.lopez@ufv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): October 13, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share