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Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds
Sponsor: Paola Vitaglione
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.
Official title: Discovering the Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2024-01-10
Completion Date
2024-12-20
Last Updated
2026-06-22
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
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.
Locations (1)
Department of Agricultural Sciences, Federico II University
Portici, Italy