Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic
      durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic
      parameters and inflammatory status, on gut permeability and functionality, on daily energy
      intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences,
      blood pressure, body composition and wellbeing status in overweight and obese subjects.
    

Detailed description: 
      Growing evidence highlights the role of the individual diet and gut microbiome in modulating
      human metabolism, inflammatory status and cardiovascular risk.

      This scenario supports nutritional approaches targeted to modify gut microbiota composition
      to trigger health benefits and the interest to develop novel functional foods enriched with
      probiotics. Most of commercial probiotic foods are in the category of dairy products and
      contain Lactobacillus strains. Besides that, Bacillus spp. along with the ability to form
      spores show probiotic attributes by exhibiting pathogen exclusion and antioxidant,
      antimicrobial and immune-modulatory abilities. Furthermore, they possess a stronger viability
      and stability to withstand high temperature processes, such as baking and boiling, than other
      probiotic bacteria thus representing an ideal choice for the development of functional
      cereal-based products.

      In particular, Bacillus clausii UBBC07 exhibits probiotic properties by alleviating the
      severity and symptoms of acute diarrhoea in adults and children and show a high stability
      over a wide range of temperatures with potential applications in a variety of formulations
      and foods. The health benefits of B. clausii UBBC07 in overweight and obese subjects is
      unexplored.

      This study aims to investigate the effects of consumption for 4 weeks of a probiotic durum
      wheat pasta enriched with spores of B. clausii UBBC07 vs a conventional durum wheat pasta
      (control) on metabolic and inflammatory status, on gut permeability and functionality, on
      daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip
      circumferences, blood pressure, body composition and wellbeing status in overweight and obese
      subjects.
    

Intervention name(s): Probiotic Pasta; Control Pasta
Intervention type(s): Other; Other
Intervention description(s): Subjects will consume for 4 weeks 80 g per day of probiotic durum wheat pasta. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.; Subjects will consume for 4 weeks 80 g per day of conventional durum wheat pasta without probiotics. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment