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

NCT ID: NCT04962633

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-12-31

Brief 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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Probiotic Pasta Group

Subjects in the Probiotic Pasta group will consume 80 g per day of a probiotic pasta for 4 weeks

Group Type: EXPERIMENTAL

Probiotic Pasta

Intervention Type: OTHER

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.

Control Pasta Group

Control Pasta Subjects in the Control Pasta group will consume 80 g per day of conventional pasta for 4 weeks.

Group Type: ACTIVE_COMPARATOR

Control Pasta

Intervention Type: OTHER

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.

Interventions

Probiotic Pasta

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.

Intervention Type: OTHER

Control Pasta

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Paola Vitaglione

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paola Vitaglione, Professor

Role: STUDY_DIRECTOR

Department of Agricultural Sciences, Federico II University

Locations

Department of Agricultural Sciences

Portici, , Italy

Countries

Italy

Other Identifiers

ProPas

Identifier Type: -

Identifier Source: org_study_id