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

Summary

The goal of this clinical trial is to investigate the effects of replacing red meat with pulses, on cardiometabolic health and gut microbiome in individuals with unhealthy habits and sedentary lifestyles at high risk for cardiovascular diseases. The main questions it aims to answer are:

1. How does the substitution of red meat with pulses affect some markers of cardiovascular risk?
2. How does this dietary intervention influence the composition and function of the gut microbiome, nutritional status, well-being indices, and biomarkers related to metabolic, oxidative, inflammatory, immune, and intestinal permeability status?

Participants will:

* be assigned to either the Pulses Diet (PulD) group or the Plant Proteins Diet (PPD) group or the Habitual diet (HabD) group;
* follow their habitual diet (HabD) or the prescribed dietary plan designed on individual habitual diet to be isocaloric and isoprotein but replacing red meat with pulses (PulD group) or a combination of pulses and plant-based meat substitutes (PPD group);
* keep their physical activity levels unchanged during the entire intervention period;
* be required to complete 7-day food diaries and associated questionnaires on appetite, along with additional questionnaires related to physical activity levels, overall well-being, mood, sleep quality, stool frequency and consistency at each nutritional intervention time-point.

Researchers will compare PulD, PPD, and HabD to assess if the dietary interventions have an impact on cardiometabolic health and gut microbiome.

Conditions

• Lifestyle-related Condition

Interventions

OTHER

Pulses diet

Subjects in the PulD group will be assigned a personalized diet prepared based on their own eating habits as established by 7-day food diary recalls. Energy values of habitual diets will be kept unchanged during the PulD intervention. The diet will be characterized by isocaloric and isoprotein substitutions, replacing habitual servings of red meat or processed meat with servings of pulses.

OTHER

Plant proteins diet

Subjects in the PPD group will be assigned a personalized diet prepared based on their own eating habits as established by 7-day food diary recalls. Energy values of habitual diets will be kept unchanged during the PPD intervention. The diet will be characterized by isocaloric and isoprotein substitutions, replacing habitual servings of red meat or processed meat with a mixture of pulses and plant-based meat substitutes.

OTHER

Habitual diet

Control subjects will not change their habitual diet during intervention. All subjects will be requested not to change physical activity levels during the 8 week intervention period.

Sponsors & Collaborators

• Paola Vitaglione

  lead OTHER

Principal Investigators

• Paola Vitaglione, Professor · Department of Agricultural Sciences, Federico II University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-10

Primary Completion

2024-10-16

Completion

2024-10-16

Countries

• Italy

Study Locations