Clinical trial NCT04962633: Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status
Official title: Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in fasting inflammatory blood markers
timeFrame: 1 months
measure: Changes in fasting plasma lipids
timeFrame: 1 months
measure: Changes in fasting plasma glucose
timeFrame: 1 months
Secondary outcomes:
measure: Changes in small intestine permeability
timeFrame: 1 month
measure: Changes in colonic permeability
timeFrame: 1 month
measure: Changes in stool consistency
timeFrame: 1 month
measure: Changes in stool weight
timeFrame: 1 month
measure: Changes in stool frequency
timeFrame: 1 month
measure: Changes in gastrointestinal functionality
timeFrame: 1 month
measure: Changes in faecal microbiome
timeFrame: 1 month
measure: Variation of plasma glucagon like peptide-1 concentration
timeFrame: 1 month
measure: Variation of plasma gastric inhibitory polypeptide hormone concentration
timeFrame: 1 month
measure: Variation of plasma Glucagon hormone concentration
timeFrame: 1 month
measure: Variation of plasma Ghrelin hormone concentration
timeFrame: 1 month
measure: Variation of plasma Insulin hormone concentration
timeFrame: 1 month
measure: Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration
timeFrame: 1 month
measure: Variation of serum dipeptidyl-dipeptidase-IV activity
timeFrame: 1 month
measure: Changes in body weight
timeFrame: 1 month
measure: Changes in body mass index
timeFrame: 1 month
measure: Changes in waist circumference
timeFrame: 1 month
measure: Changes in hip circumference
timeFrame: 1 month
measure: Changes in blood pressure
timeFrame: 1 month
measure: Changes in body composition
timeFrame: 1 month
measure: Variation of daily energy intakes
timeFrame: 1 month
measure: Variation of hunger sensation scores
timeFrame: 1 month
measure: Variation of fullness sensation scores
timeFrame: 1 month
measure: Variation of satiety sensation scores
timeFrame: 1 month
measure: Variation of wellbeing status
timeFrame: 1 month
Other outcomes:
Locations:
city: Portici
country: Italy
facility: Department of Agricultural Sciences
Study officials:
affiliation: Department of Agricultural Sciences, Federico II University
name: Paola Vitaglione, Professor
role: STUDY_DIRECTOR
References: