Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status (ProPas)

Federico II University

Status

Completed

Conditions

Overweight and Obesity

Treatments

Other: Control Pasta

Other: Probiotic Pasta

Study type

Interventional

Funder types

Other

Identifiers

NCT04962633

ProPas

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

healthy subjects;
men and women;
age 18-65 years;
25 kg/m2 ≤ BMI ≤ 35 kg/m2;
habitual daily pasta consumption (≥ 1 portion/day);
habitual diet characterized by absence of any food supplements and alternative medication, probiotics and prebiotics, whole grain and/or fiber enriched foods;
intake of fruit/vegetables < 3 servings/day;
low level of physical activity (< 500 metabolic equivalent min/week);
signed written informed consent.

Exclusion criteria

food allergies and intolerances and celiac disease;
gastrointestinal diseases;
relevant diseases;
pregnant or breastfeeding;
previous abdominal surgery;
hypertriglyceridemia (Triglycerides > 200 mg/dL);
hypercholesterolemia (Total cholesterol > 200 mg/dL);
hyperglycaemia (glycaemia ≥ 110 mg/dL);
hypertension (arterial blood pressure ≥140/90 mm Hg);
weight loss ≥ 3 kg within 2 months before the study;
antibiotics treatment within 3 months before the study;
any medication (different from antibiotics) at the enrollment and within 2 months before the study;
habitual diet characterized by high fruit and vegetables intakes (>3 portion/die);
high level of physical activity;
Alcohol consumption ≥ 3 alcohol units per day;
simultaneous participation in other trial.