Replacing red meat with pulses to improve heart health and gut microbiome

Discovering the Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds

This study is testing if swapping red meat for pulses can improve heart health and gut bacteria in people with unhealthy habits who are at risk for heart disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Federico II University (Academic / other)
• Locations: 1 site (Portici)
• Trial ID: NCT05999136 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of substituting red meat with pulses on cardiometabolic health and gut microbiome in individuals with unhealthy habits and sedentary lifestyles at high risk for cardiovascular diseases. Participants will be assigned to one of three dietary groups: a Pulses Diet, a Plant Proteins Diet, or a Habitual Diet. The study aims to assess how these dietary changes affect cardiovascular risk markers, gut microbiome composition, and various health indices. By focusing on the nutritional benefits of legumes, the trial seeks to provide insights into healthier dietary practices.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18-65 with a BMI between 20 and 35 who consume a high amount of red meat and lead a sedentary lifestyle.

Not a fit: Patients with significant medical conditions, food allergies, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular health and better gut microbiome function for patients at risk of heart disease.

How similar studies have performed: Previous studies have shown positive associations between high legume consumption and reduced cardiovascular risks, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* men and women aged 18-65;
* 20 ≤ BMI ≤ 35 kg/m2;
* habitual diet characterized by ≥ 3 medium servings of fresh red meat or processed meat (equivalent to a portion weight of 100g of fresh meat and 50g of cured meats);
* habitual diet without probiotics, functional foods, and/or any type of food supplements;
* low level of physical activity (sedentary lifestyle);
* signing the informed consent form and expressing consent for the processing of personal data.

Exclusion Criteria:

* Food allergies and intolerances, such as celiac disease, lactose intolerance, and others;
* Gastrointestinal disorders of any kind;
* Significant medical conditions;
* Pregnancy or breastfeeding;
* Hypertriglyceridemia (Triglycerides \> 200 mg/dL);
* Hypercholesterolemia (Cholesterol \> 200 mg/dL);
* Diabetes (Blood glucose ≥ 126 mg/dL);
* Hypertension (Blood pressure \> 140/90 mm Hg);
* Weight loss ≥ 3 kg in the past 2 months prior to the study;
* Use of any medication at enrollment and in the 2 months prior to the study;
* Regular diet rich in fruits and vegetables;
* Consumption of alcohol equivalent to or exceeding 3 glasses of wine per day;
* Concurrent participation in other clinical trials.

Where this trial is running

Portici

• Department of Agricultural Sciences, Federico II University — Portici, Italy (Recruiting)

Study contacts

• Study coordinator: Paola Vitaglione, Professor

Conditions Lifestyle-related Condition; Gut microbiome; Legumes; Pulses; Plant proteins; Cardiovascular diseases; Red meat substitution; Protein transition